The Right Tools to Build Your EU Compliance Roadmap

MDR - Competent Authorities

‘market surveillance’ means the activities carried out and measures taken by competent authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection;

Mainly MDR Section 3 Market surveillance, Article 101-102, 110, 113

Getting ready for the new regulations (EC)
- Competent authorities in non-EU/EEA countries (EC)
Factsheet for Authorities in non-EU/EEA States on MDs and IVDs
MDR/IVDR Roadmap
MDR Transitional Q&A
List of MDR requirements for manufacturers (MHRA)
Guide for Distributors of Medical Devices (HPRA)
Open letter from the CAMD Executive Group on EUDAMED
Reference list for Class I medical device manufacturers (HPRA)
Guide to Notified Bodies – Designation Process (HPRA)

IVDR - Competent Authorities

Mainly IVDR Article 6.3., 10.7., 10.8., 10.11, 10.13, 11, 13, 14, 16.4., 20.1., 22.2., 28, 31.6., 36, 42, 47-50, 54, 58.2., 78.4., 80, 81.2-3., 82-97, 102, 110.9., Annex I 20.4.1.(af), Annex III 1. (b), Annex VII 1.1.6. (g), 1.2.6., 1.3.1., 4.5.5., 4.10., Annex IX 5.2., 6, Annex X 3. (k), 5.5., 6., Annex XI 6., Annex XIV 1.7., 1.16., 4.6. and Chapter II 3.

Getting ready for the new regulations (EC)
- Competent authorities in non-EU/EEA countries (EC)
MDR/IVDR CAMD Roadmap
Guide to Notified Bodies – Designation Process (HPRA)

MDR - Health Professionals and Health Institutions

‘health institution’ means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health;

Mainly MDR Article 5.5., 17.3.-4., 18.2., 25.2. (c), 27.1. (c), 27.9, 121, Annex XIII

Getting ready for the new regulations (EC)
- Healthcare professionals and health institutions (EC)
- Health institutions reprocessing single-use devices (EC)
Factsheet for healthcare professionals and health institutions (EC)
Procurement Guidelines for Cybersecurity in Hospitals (ENISA)

IVDR - Health Professionals and Health Institutions

‘health institution’ means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health

Mainly IVDR Article 5.4., 5.5., 22.2(c), 24.1. (c), 24.9., 111

Getting ready for the new regulations (EC)
- Healthcare professionals and health institutions (EC)
Factsheet for healthcare professionals and health institutions (EC)
Procurement Guidelines for Cybersecurity in Hospitals (ENISA)

IVDR - Importer

‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market;

‘economic operator’ means a manufacturer, an authorised representative, an importer or a distributor;

Mainly IVDR Article 10.11., 13, 14.2.-5., 16, 22, 27-28, 110.8., Annex III 1. (a), Annex VI Part A

Getting ready for the new regulations (EC)
- Authorised Representatives, Importers, Distributors (EC)

MDR - Importer

‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market;

Mainly MDR Article 13, 16, 25, 30,31, Annex VI

Getting ready for the new regulations (EC)
- Authorised Representatives, Importers, Distributors (EC)
SNITEM MDR Summary for Importers

IVDR - Distributor

‘economic operator’ means a manufacturer, an authorised representative, an importer or a distributor;

‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service;

Mainly IVDR Article 10.11., 13.6., 14, 16, 22, 27.2., Annex III 1. (a)

Getting ready for the new regulations (EC)
- Authorised Representatives, Importers, Distributors (EC)
Guide for Distributors of Medical Devices (HPRA – Irish competent authority)

MDR - Distributor

‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service;

Mainly MDR Article 10.12., 13.6., 14, 16, 25, 30, Annex XIII

Getting ready for the new regulations (EC)
- Authorised Representatives, Importers, Distributors (EC)
Guide for Distributors of Medical Devices (HPRA – Irish competent authority)
SNITEM MDR Summary for Distributors

IVDR - Authorised Representative

‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under this Regulation;

‘economic operator’ means a manufacturer, an authorised representative, an importer or a distributor;

Mainly IVDR Article 10.7.-8., 11, 12, 13.2., 13.6-8., 14.2., 14.4-6., 15.6., 22, 27-28, 47.2., 55.1., 85, 90.1., 110. 8., Annex I 20.2. (d), Annex IV 1., Annex VI Part A, Part B 7., Annex VII 1.2.3., 4.3., Annex IX 2.1.-2., Chapter III 2., 6.,7., Annex X 2., 6. 7, Annex XI 6., Annex XII Chapter II 2., Annex XIV 1.2.

Getting ready for the new regulations (EC)
- Authorised Representatives, Importers, Distributors (EC)
Factsheet for Authorised Representatives, Importers and Distributors of MDs and IVDs

MDR - Authorised Representative

‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under this Regulation;

Mainly MDR Article 11, Article 12, Article 15(6), Article 25, Article 30, Article 31, Article 60, Article 90, Article 95,.. Annex VI, Annex XIII

Getting ready for the new regulations (EC)
- Authorised Representatives, Importers, Distributors (EC)
Swiss MedTech Guide on designating EC RP under MDR (French language) (German language)
Factsheet for Authorised Representatives, Importers and Distributors of MDs and IVDs
SNITEM MDR Summary for Authorised Representatives

MDR - Notice for Manufacturers

Getting ready for the new regulations (EC)
- Manufacturers MD (EC)
- Manufacturers of devices without an intended medical purpose (EC)
MDCG Joint Implementation/Preparedness Plan for MDR (MDCG)
MDCG Guidance notes for manufacturers of Class I Medical Devices (MDCG)
New rules to ensure safety
MDR and IVDR – Infographics
MedTech Europe MDR Flowchart on the new requirements
Implementation Model for MDR – Step by Step Guide (November 2018)
Step by step MDR Implementation model (July 2018)
Factsheet for the Procurement Ecosystem of MD and IVDs

MDR - Manufacturer

‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark;

Mainly MDR Article 10, 15, 18, 25, 29, 30, Chapter V, Annex I-VI, Annex VII-XVI

Getting ready for the new regulations (EC)
- Manufacturers MD (EC)
- Manufacturers of devices without an intended medical purpose (EC)
Q&A Document regarding the Implementation of the new Manufacturer Incident Report (MIR) Form
Manufacturer Incident Report Form 2020
European Medicines Agency Questions & Answers on Implementation of MDR and IVDR (EMA)
Factsheet for manufacturers of Medical Devices (July 2018)
Factsheet for Manufacturers of Medical Devices (November 2018)
List of MDR requirements for manufacturers (MHRA)
MIR (Manufacturer Incident Report) and related helptext under MDR/IVDR and Directives (December 2018)
Reference list for Class I medical device manufacturers (HPRA)

IVDR - Notice for Manufacturers

Getting ready for the new regulations – Manufacturer IVD (EC)
MDR and IVDR – Infographics
MedTech Europe IVDR Flowchart on the new requirements
Implementation Model for IVDR – Step by Step Guide (November 2018)
Factsheet for the Procurement Ecosystem of MD and IVDs

IVDR - Manufacturer

‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark;

‘economic operator’ means a manufacturer, an authorised representative, an importer or a distributor;

Getting ready for the new regulations – Manufacturer IVD (EC)
European Medicines Agency Questions & Answers on Implementation of MDR and IVDR (EMA)
Factsheet for Manufacturers of in vitro Diagnostic Medical Devices
MIR (Manufacturer Incident Report) and related helptext under MDR/IVDR and Directives (December 2018)

IVDR - European Commission

Getting ready for the new regulations (EC)
- Manufacturer IVD (EC)
- Authorised Representatives, Importers, Distributors (EC)
- Healthcare professionals and health institutions (EC)
- Competent authorities in non-EU/EEA countries (EC)
- The procurement of MDs and IVDs (EC)
Implementation Rolling Plan – December 2020 (EC)
Commission Notice on the application of Sections 2.3 and 3.3 of Annex IX to Regulation (EU) 2017/745 and Regulation (EU) 2017/746 with regard to notified bodies’ audits performed in the context of quality management system assessment (EC)
Commission Notice – The annual Union work programme for European standardisation for 2021 (EC)
NB Assessment State-of-play (EC)
Commission Recommendation of 18.11.2020 on the use of rapid antigen tests for the diagnosis of SARS-CoV-2 infection(EC)
Communication: Building a European Health Union – preparedness and resilience (EC)
Factsheet – The role of EU agencies (EC)
Proposal to extend the mandate of the European Medicines Agency (EC)
Proposal to extend the mandate of the European Centre for Disease Prevention and Control (EC)
Proposal for a Regulation on serious cross-border threats to health (EC)
Rolling plan (EC)
Commission Implementing Decision C(2020) 2532 of 15.5.2020 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization as regards medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746 of the European Parliament and of the Council
Commission Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the Covid-19 context.
Flyer – Call for expression of interest for expert panels on medical devices on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
UDI System Factsheet – FAQs
MDR and IVDR – Infographics
Implementation Model for IVDR – Step by Step Guide (November 2018)
Factsheet for the Procurement Ecosystem of MD and IVDs

MDR - European Commission

Getting ready for the new regulations (EC)
- Manufacturers MD (EC)
- Manufacturers of devices without an intended medical purpose (EC)
- Authorised Representatives, Importers, Distributors (EC)
- Healthcare professionals and health institutions (EC)
- Health institutions reprocessing single-use devices (EC)
- Competent authorities in non-EU/EEA countries (EC)
- The procurement of MDs and IVDs (EC)
Implementation Rolling Plan – December 2020 (EC)
Commission Notice on the application of Sections 2.3 and 3.3 of Annex IX to Regulation (EU) 2017/745 and Regulation (EU) 2017/746 with regard to notified bodies’ audits performed in the context of quality management system assessment (EC)
Commission Notice – The annual Union work programme for European standardisation for 2021 (EC)
NB Assessment State-of-play (EC)
Communication: Building a European Health Union – preparedness and resilience (EC)
Factsheet – The role of EU agencies (EC)
Proposal to extend the mandate of the European Medicines Agency (EC)
Proposal to extend the mandate of the European Centre for Disease Prevention and Control (EC)
Proposal for a Regulation on serious cross-border threats to health (EC)
Implementation Rolling plan – October 2020 (EC)
Commission Implementing Regulation (EU) 2020/1207: Common specifications for the reprocessing of single-use devices
Commission Guidance for the medical devices expert panels on the consistent interpretation of the decision criteria in the clinical evaluation consultation procedure (EC)
Fact sheet on MDR requirements for Transparency and Public Information (EC)
Survey on availability and capacity of notified bodies to carry out conformity assessments for COVID-19 essential devices (EC)
Guidance on regulatory requirements for medical face masks (EC)
Commission Implementing Decision C(2020) 2532 of 15.5.2020 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization as regards medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746 of the European Parliament and of the Council
Commission Communication on Aricle 59 of the MDR – Union-wide derogations (EC)
Commission Implementing Regulation (EU) 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies(EC)
Commission Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the Covid-19 context.
Conformity assessment procedures for protective equipment – COVID 19 (EC)
Commission Implementing Decision (EU) 2020/437 of 24 March 2020 on the harmonised standards for medical devices drafted in support of Council Directive 93/42/EEC
Commission Implementing Decision (EU) 2020/438 of 24 March 2020 on the harmonised standards for active implantable medical devices drafted in support of Council Directive 90/385/EEC
Commission Recommendation on conformity assessment and market surveillance procedures within the context of the COVID-19 threat
Factsheet on phthalates (SCHEER)
Flyer – Call for expression of interest for expert panels on medical devices on medical devices and in vitro diagnostic medical devices (2019/C 323/05)
UDI System Factsheet – EC FAQs
MDR and IVDR – EC Infographics
Implementation model for MDR – Step by Step Guide (November 2018) (EC)
Factsheet for the Procurement Ecosystem of MD and IVDs (EC)
Step by step MDR Implementation model (July 2018) (EC)
New rules to ensure safety (EC)

MDR - UK & Switzerland

UK

UK approved bodies for medical devices (MHRA)
Designated standards: medical devices (MHRA) & Designated standards: active implantable medical devices (MHRA)
Guidance for retailers: supplying medical devices to Northern Ireland(MHRA)
Guidance: Register as a manufacturer to sell medical devices from 1 January 2021 (MHRA)
Guidance: Regulating medical devices from 1 January 2021 (MHRA)
”Brexit readiness checklist” for companies doing business in the UK (EC)
Notice to Stakeholders: Withdrawal of the UK and EU rules for medicinal products for human use and veterinary products (EC)
Readiness notice for industrial products (EC)

Switzerland

Swiss MedTech Guide on designating EC RP under MDR (French language) (German language)
Swiss MedTech Notice to manufacturers (French language)

IVDR - UK & Switzerland

UK

UK approved bodies for medical devices (MHRA)
Designated standards: in vitro diagnostic medical devices (MHRA)
Guidance for retailers: supplying medical devices to Northern Ireland (MHRA)
Guidance on the regulation of In Vitro Diagnostic medical devices in Great Britain (MHRA)
Guidance: Register as a manufacturer to sell medical devices from 1 January 2021 (MHRA)
Guidance: Regulating medical devices from 1 January 2021 (MHRA)
”Brexit readiness checklist” for companies doing business in the UK (EC)
Notice to Stakeholders: Withdrawal of the UK and EU rules for medicinal products for human use and veterinary products (EC)
Readiness notice for industrial products (EC)

Switzerland

Swiss MedTech Notice to manufacturers (French language)

IVDR - EUDAMED

European database on medical devices (Eudamed)

Mainly IVDR Article 23, 26, 28-30, 113.3. (f)

ACTOR MODULE FAQs – Questions and Answers
Access to EUDAMED database – active from 1 December
EUDAMED webpage – active from 1 December
Actor roles and SRN
Video: Demo actor registration module
Infographic: Actor registration request process
Declaration on information security responsibilities (template in all EU languages)
Mandate Summary document
Users access requests – For an actor already registered in EUDAMED, all persons who intend to act on behalf of this actor need to enter an access request
User guide for Economic Operators Guide to using EUDAMED
Actor Module Business Process Search for available translations of the preceding link – the M2M management will only be available when the UDI/Device module will be made available
Actor Module Business Rules
AIM-Business Process – the first NB LAA will only be available when the certificate module will be made available
AIM-Business Rules
Guidance documents to assist stakeholders in implementing the medical devices regulations
MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States (MDCG)
MDCG Timelines for registration of device data elements in EUDAMED (MDCG)
The CND Nomenclature (EC) – basis for the future EMDN
European Medical Device Nomenclature (EMDN) – the nomenclature of use in EUDAMED (EC)
EUDAMED Functional Specifications
Medical devices Nomenclature
Eudamed Data exchange services and entity models introductions
M2M Data Exchange Services Definition
Eudamed Data Exchange Guidelines

MDR - MDCG

Medical Device Coordination Group – MDCG

Each Member State shall appoint to the MDCG, for a three-year term which may be renewed, one member and one alternate each with expertise in the field of medical devices, and one member and one alternate with expertise in the field of in vitro diagnostic medical devices.

Mainly MDR Article 103- Article 107

Documents

2020-18 MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers (MDCG)
2020-17 – Questions and Answers related to MDCG 2020-4 (MDCG)
Ongoing Guidance development within MDCG Subgroups (MDCG)
2020-15 Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States (MDCG)
2020-14 Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR) (MDCG)
2020-13 Clinical evaluation assessment report template (MDCG)
2018-3 Rev.1 Guidance on UDI for systems and procedure packs (MDCG)
2020-12 Transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product […] as well as on devices manufactured using TSE susceptible animal tissues (MDCG)
2020-11 Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation (MDCG)
2020-10/2 Clinical Investigation Summary Safety Report Form v1.0 (MDCG)
2020-10/1 Guidance on Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745 (MDCG)
2020-9 Regulatory Requirements for Ventilators and Related Accessories (MDCG)
2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies (MDCG)
2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies (MDCG)
2020-6 Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies (MDCG)
2020-5 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies (MDCG)
2020-4 Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions (MDCG)
2020-03 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD (MDCG)
2020-02 Class I Transitional provisions under Article 120 (3 and 4) – (MDCG)
2020-01 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software (IVDR) (MDCG)
Joint Implementation/preparedness plan on the new Medical Devices Regulation 2017/745 (MDR) (MDCG)
2019-16 Guidance on Cybersecurity for medical devices (MDCG)
2019-15 Guidance notes for manufacturers of Class I Medical Devices (MDCG)
2019 -14 Explanatory note on MDR Codes (MDCG)
2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation (MCDG)
2019-12 Designating authority’s final assessment form: Key Information (EN) (MDCG)
2019-11 Guidance document on Qualification and Classification of Software in MDR and IVDR (MDCG)
2019-10 Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC (MDCG)
2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies – August 2019 (MDCG)
2019-8 V2 Guidance document on implant card -Article 18 (MDCG)
2019-8 Guidance document Implant Card – Article 18 (MDCG)
2019-7 Guidance on “person responsible for regulatory compliance” – PRRC (MDCG)
2019-6 Questions and answers: Requirements relating to notified bodies (MDCG)
2019-5 Registration of legacy devices in EUDAMED (MDCG)
2019-4 Timelines for registration of device data elements in EUDAMED (MDCG)
2019-3 Interpretation of Article 54(2)b (MDCG) – Revision 1
2019-3 Interpretation of Article 54(2)b (MDCG)
2019-2 Guidance on application of UDI rules to devices incorporating medicinal substance, human tissues and cells (MDCG)
2019-1 V2 Guiding principles for issuing entities rules on Basic UDI-DI (MDCG)
2018-8 Guidance on content of the certificates, voluntary certificate transfers(MDCG)
2018-7 Provisional considerations regarding language issues associated with the UDI database (MDCG)
2018-6 Clarifications of UDI related responsibilities in relation to Article 16 (MDCG)
2018-5 UDI assignment to medical device software (MDCG)
2018-4 Definitions/descriptions and formats of the UDI core elements for systems or procedure packs (MDCG)
2018-3 Guidance on UDI for systems and procedure packs (MDCG and Annex)
2018-2 Future EU medical device nomenclature – Description of requirements (MDCG)
2018-1 V3 Guidance on Basic UDI-DI and changes to UDI-DI (MDCG)
2018-1 V2 Guidance on Basic UDI-DI and changes to UDI-DI (MDCG)
2018-1 Draft guidance on Basic UDI-DI and changes to UDI-DI (MDCG)

Meetings (Minutes /Agendas)

Planned meetings of MDCG and subgroups for 2020
Meeting of MDCG (main group) – 07-08/12/2020 – Draft Agenda
Meeting of MDCG – ANNEX XVI working group meeting – 12/11/2020 – Draft Agenda
Meeting of MDCG – Unique Device Identification working group meeting – 09/11/2020- Draft Agenda
Meeting of MDCG MDR EUDAMED VIGILANCE – 29/10/2020 – Draft Agenda
Meeting of MDCG – New Technologies working group – 23/10/2020- Draft Agenda
Meeting of MDCG – EUDAMED working group meeting – 19/10/2020 – Draft Agenda
Meeting of MDCG Nomenclature working group – 12/10/2020 – Draft Agenda
Meeting of the Post Market Surveillance and Vigilance sub-group of the MDCG – 28/09/2020 – Draft Agenda
Meeting of the ANNEX XVI sub-group of the MDCG – 16/09/2020 – Draft Agenda
Extraordinary meeting of the MDCG on Joint Assessments of notified bodies during quarantine orders and travel restrictions – 14/09/2020 – Draft Agenda
Meeting of the International Matters sub-group of the MDCG – 08/09/2020 – Draft Agenda
Meeting of the MDCG (MDR – IVDR) – 02/07/2020-Draft Agenda
Meeting between the MDCG and the Stakeholders – 02/07/2020- Draft Agenda
Meeting of the Unique Device Identification sub-group of the MDCG- 30/06/2020- Draft Agenda
Meeting of the EUDAMED sub-group of the MDCG – 25/06/2020 – Draft Agenda
Meeting of the Notified Bodies Oversight sub-group of the MDCG – Draft Agenda
Meeting of the STANDARDS sub-group of MDCG 19/06/2020 – Draft Agenda
Meeting of the MARKET SURVEILLANCE sub-group of MDCG 18/06/2020 – Draft Agenda
Meeting of the Notified Bodies Oversight subgroup of MDCG 16/06/2020 – Draft Agenda
Meeting of the IVD sub-group of MDCG – Competent Authorities with Stakeholders 25/05/2020
(CANCELLED) Meeting between the MDCG and Stakeholders (MDR-IVDR) 12/03/2020 – Draft Agenda
Meeting of the MDCG (MDR/IVDR) 11/03/2020- 12/03/2020 – Draft Agenda
High level meeting of the MDCG (MDR/IVDR) 11/03/2020 – Draft Agenda
Meeting of the UDI sub-group of MDCG (MDR – IVDR) 17/02/2020 – Draft Agenda
Meeting of the MDCG (MDR – IVDR) 13/12/2019 – Draft agenda
Meeting (extraordinary) of the MDCG (MDR – IVDR) 21/11/2019 – No public minutes
Meeting of the MDCG (MDR – IVDR) 01/10/2019 – No public minutes
Meeting between the MDCG and stakeholders 30/09/2019 – No public minutes
Meeting of the MDCG (MDR – IVDR) 20/06/2019
Meeting of the STANDARDS sub-group of MDCG 20/05/2019
Meeting of the MDCG (MDR – IVDR) 09/04/2019
Meeting of the NBO sub-group of MDCG 29/03/2019
Meeting of the PMSV sub-group of MDCG and stakeholders 05/03/2019
Meeting with stakeholders 14/02/2019 – No public minutes
Meeting (MDR – IVDR) 14/02/2019 – No public minutes
Meeting (MDR – IVDR) 30/11/2018 – No public minutes
Minutes (MDR – IVDR) – 11/10/2018
Meeting with stakeholders – 24/09/2018
Minutes (MDR – IVDR) – 24/09/2018
Minutes (MDR – IVDR)- 17/07/2018
Minutes (MDR – IVDR) – 02/05/2018
Minutes (MDR – IVDR) – 06/03/2018
Meeting with stakeholders – 05/03/2018

Procedural aspects

Rules of procedure of the MDCG
Terms of references of the MDCG Working Groups:
- MDCG Working Group 1: Notified Bodies Oversight (NBO)
- MDCG Working Group 2: Standards
- MDCG Working Group 3: Clinical Investigation and Evaluation (CIE)
- MDCG Working Group 4: Post-Market Surveillance and Vigilance (PMSV)
- MDCG Working Group 5: Market Surveillance
- MDCG Working Group 6: Borderline and Classification (B&C)
- MDCG Working Group 7: New Technologies
- MDCG Working Group 10: International Matters
- MDCG Working Group 11: In vitro diagnostic medical devices (IVD)

MDR - Notified Body

‘notified body’ means a conformity assessment body designated in accordance with this Regulation;

Mainly MDR Chapter IV, Article 58, Annex VII, Annex XII

Commission Notice on the application of Sections 2.3 and 3.3 of Annex IX to Regulation (EU) 2017/745 and Regulation (EU) 2017/746 with regard to notified bodies’ audits performed in the context of quality management system assessment (EC)
NB Assessment State-of-play (EC)
Questions and Answers related to MDCG 2020-4 – audits during COVID-19 (MDCG)
Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR) (MDCG)
Clinical evaluation assessment report template (MDCG)
Update to the NB designation process (EC)
Survey: Notified bodies’ availability and capacity to carry out conformity assessments for COVID-19 essential devices (EC)
Commission Implementing Regulation (EU) 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies (EC)
Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews (IMDRF)
Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews (IMDRF)
Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews (IMDRF)
Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions (MDCG)
State of play of joint assessments of Notified Bodies in the medical device sector (EC)
MDCG Explanatory note on MDR Codes (MDCG)
MDCG Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation (MCDG)
EC website with the designated NBs (NANDO)
MDCG Designating authority’s final assessment form: Key Information
NBOG Designation and notification of NB (Guidance)
NBOG Change of Notified Body (Guidance)
MDR NB Designation process update (18.12.2018)
BSi White papers on MDR/IVDR
TÜV SÜD on MDR and IVDR
Med Tech Europe Info Sheet on Notified Bodies
Guidance on content of the certificates, voluntary certificate transfers(MDCG)
Commission Implementing Regulation (EU) 2017/2185: Designation of notified bodies (MDR/IVDR)
Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System (NBOG)
Guide to Notified Bodies – Designation Process (HPRA)

IVDR - Notified Body

‘notified body’ means a conformity assessment body designated in accordance with this Regulation;

Mainly IVDR Article 10.11., 11.6., 11.7., 16.4., 18.5., 26, 28, 29, Chapter IV & V (Articles 31- 55), 78.4., 80-81, 83-84, 87.9., 90, 94-95, 110, Annex IV 8., Annex VI 2., Annex VII, Annex IX-XI, Annex XIV 1.15.,

Commission Notice on the application of Sections 2.3 and 3.3 of Annex IX to Regulation (EU) 2017/745 and Regulation (EU) 2017/746 with regard to notified bodies’ audits performed in the context of quality management system assessment (EC)
NB Assessment State-of-play (EC)
2020-17 – Questions and Answers related to MDCG 2020-4 (MDCG)
Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions (MDCG)
Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR) (MDCG)
Update to the NB designation process (EC)
Survey: Notified bodies’ availability and capacity to carry out conformity assessments for COVID-19 essential devices (EC)
Regulatory Authority Assessment Method for Recognition and Surveillance of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews (IMDRF)
Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews (IMDRF)
Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews (IMDRF)
State of play of joint assessments of Notified Bodies in the medical device sector (EC)
MDCG Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation (MCDG)
EC website with the designated NBs (NANDO)
IVDR NB Designation process update (17.1.2019)
MDCG Designating authority’s final assessment form: Key Information
BSi White papers on MDR/IVDR
TÜV SÜD on MDR and IVDR
Commission Implementing Regulation (EU) 2017/2185: Designation of notified bodies (MDR/IVDR)
Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System (NBOG)
Guide to Notified Bodies – Designation Process (HPRA)

MDR - Law

Proposal to extend the mandate of the European Medicines Agency (EC)
Proposal to extend the mandate of the European Centre for Disease Prevention and Control (EC)
Proposal for a Regulation on serious cross-border threats to health (EC)
Commission Implementing Regulation (EU) 2020/1207: Common specifications for the reprocessing of single-use devices
MDR Consolidated version 24.04.2020 (Text of the Regulation)
Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions (Text with EEA relevance)
Draft REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions
European Parliament text:Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions – Outcome of the European Parliament’s first reading (Brussels, 16-17 April 2020)
Council text: Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions – Mandate for negotiations with the European Parliament
European Commission text: Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions
Regulation on Medical Devices (MDR Consolidated version)
Regulation on Medical Devices (MDR)
MDR V2 Corrigendum II (Draft MDR V2 Corrigendum)
MDR V1 Corrigendum II
MDR Corrigendum I
Commission Implementing Regulations (Implementation rolling plan)
Commission Implementing Regulation (EU) 2017/2185: Designation of notified bodies (MDR/IVDR)
Commission Implementation Decision (EU) 2019/1396: Designation of expert panels

National implementing legislation

Poland: Ustawa z dnia 20 maja 2010 r. o wyrobach medycznych
Austria: Gesamte Rechtsvorschrift für Medizinproduktegesetz, Fassung vom 23.03.2020
Czech Republic: Act on medical devices
Belgium: Arrete royal relatif aux investigations cliniques des dispositifs médicaux
Belgium: Arrêté royal portant exécution de la loi du xxx relative aux dispositifs médicaux
Belgium: Avant-projet de la Loi relative aux dispositifs médicaux (Draft)
Belgium: Royal Decree implementing the Law of xxx on medical devices
The Netherlands: Wet medische hulpmiddelen (Draft); Decree on medical devices
Germany: Gesetzes zur Anpassung des Medizinprodukterechts an die Verordnung (EU) 2017/745 und die Verordnung (EU) 2017/746 (Draft)
Slovenia: Uredba o izvajanju uredbe (EU) o medicinskih pripomočkih (Draft)
Croatia: Zakon o provedbi Uredbe (EU) 2017/745 o medicinskim proizvodima i Uredbe (EU) 2017/746 o in vitro dijagnostičkim medicinskim proizvodima
Germany: Medizinprodukte-EU-Anpassungsgesetz – MPEUAnpG (Bundestag)
Serbia: Zakon o medicinskim sredstvima

MDR - Post-Market Surveillance

‘post-market surveillance’ means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;

Mainly MDR Articles 8, 9, 10.9.-10., 15.3, 32.2., 61.9., 83-92, 120.3, Annex I 3., Annex III, Annex VII 4.5.2.-11., Annex IX, Annex XIV

WHO Implementation of post-market surveillance for manufacturers of medical devices,including in vitro diagnostic medical devices (IVDs), used in cervical cancer programmes (WHO)
EU device specific vigilance guidance on lnsulin infusion pumps and integrated meter systems (EC) – MDD
WHO Guidance on post-market and market surveillance of medical devices including IVDs (WHO)
Questions and Answers document regarding the Implementation of the new Manufacturer Incident Report (MIR) Form (European Commission)
Manufacturer incident report 2020 (European Commission)
Manufacturer incident report for importing XML file with Adobe Professional 2020 (European Commission)
Changelog file 2020
Manufacturer incident report Helptext 2020 (European Commission)
Breast Implants – Guidance on the vigilance system for CE-marked medical devices (European Commission -DSVG 04)
Cardiac Implantable Electronic Devices (CIED) – Guidance on the vigilance system for CE-marked medical devices(European Commission – DSVG 03)
IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (IMDRDF)

MDR - UDI

‘Unique Device Identifier’ (‘UDI’) means a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market;

Mainly MDR Article 27, 28, Annex VI

MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers (MDCG)
Unique Device Identification (UDI) System – FAQs (European Commission)
Guidance on UDI for systems and procedure packs (MDCG) – Rev.1
MedTech Europe Guidance on Basic UDI-DI (MedTech Europe)
Guidance on BASIC UDI-DI and changes to UDI-DI (MDCG) – V3
GS1 (UDI Issuing entity) contacts
GS1 Basic UDI-DI and GS1 UDI HRI & AIDC Formats
IFA Basic UDI-DI and IFA UDI HRI & AIDC Formats
HIBCC Basic UDI-DI and HIBCC UDI HRI & AIDC Formats
ICCBBA Basic UDI-DI and ICCBBA UDI HRI & AIDC Formats
MDR – UDI and device data sets to provide in EUDAMED (European Commission)
UDI Assignment to Medical Device Software (MDCG)
UDI related responsibilities of distributors and importers under MDR Article 16 (MDCG)
Language issues associated with UDI database (MDCG)
MDCG Working Group 9: Unique Device Identification (UDI) (MDCG)
UDI Database, Definitions/Descriptions and formats of the UDI core elements (UDIWG)
The architecture of the UDI database – Basic UDI-DI and UDI-DI attributes (UDIWG)
Guiding principles for issuing entities rules on Basic UDI-DI (MDCG)
Guidance on application of UDI rules to devices incorporating medicinal substance, human tissues and cells (MDCG)
Draft guidance on Basic UDI-DI and changes to UDI-DI (MDCG)
Guidance on UDI for systems and procedure packs (MDCG and Annex)
Registration of legacy devices in EUDAMED (MDCG)
UDI System Application Guide (IMDRF)
1-pager on UDI (SNITEM)

GS1

10 step plan (GS1)
Latest brochure on UDI in Europe (GS1)
Executive summary about the GMN standard (GS1)
GMN standard update (GS1)
GMN check calculator (GS1)
GMN Helper library (GS1)
GMN management guidance regarding mergers and acquisitions Position Paper (GS1)
Search engine for GTINs owners (GEPIR, Global Electronic Party Information Register) (GS1)
GTIN check digit calculator (GS1)
GS1 Healthcare GTIN allocation rules (GS1)

MDR - EUDAMED

European database on medical devices – Eudamed

Mainly MDR Articles 26, 28, 29, 30, 33-34, 57, 92, 100, 108

ACTOR MODULE FAQs – Questions and Answers
Access to EUDAMED database – active from 1 December
EUDAMED webpage – active from 1 December
Actor roles and SRN
Video: Demo actor registration module
Infographic: Actor registration request process
Declaration on information security responsibilities (template in all EU languages)
Mandate Summary document
Users access requests – For an actor already registered in EUDAMED, all persons who intend to act on behalf of this actor need to enter an access request
User guide for Economic Operators Guide to using EUDAMED
Actor Module Business Process Search for available translations of the preceding link – the M2M management will only be available when the UDI/Device module will be made available
Actor Module Business Rules
AIM-Business Process – the first NB LAA will only be available when the certificate module will be made available
AIM-Business Rules
Guidance documents to assist stakeholders in implementing the medical devices regulations
The CND Nomenclature (EC) – basis for the future EMDN
MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States (MDCG)
MDCG Registration of legacy devices in EUDAMED (MDCG)
MDCG Timelines for registration of device data elements in EUDAMED (MDCG)
European Medical Device Nomenclature (EMDN) – the nomenclature of use in EUDAMED (EC)
Timelines for registration of device data elements in EUDAMED (MDCG)
EUDAMED Functional Specifications
MDR Eudamed Registration – Planning / Roadmap
MDR Eudamed Registration – Actors – Users
Medical devices Nomenclature
Mangement of legacy devices – MDR EUDAMED (EC)
Eudamed Data exchange services and entity models introductions
M2M Data Exchange Services Definition
Eudamed Data Exchange Guidelines
Open letter from the CAMD Executive Group on EUDAMED

MDR - Clinical evaluation

‘clinical evaluation’ means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

Mainly MDR Chapter VI, Article 54, Annex XIV, Annex XV

Commission Guidance for the medical devices expert panels on the consistent interpretation of the decision criteria in the clinical evaluation consultation procedure
Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745 (MDCG)
Clinical Investigation Summary Safety Report Form v1.0 (MDCG)
Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies (MDCG)
Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies (MDCG)
Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies (MDCG)
Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies (MDCG)
Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software (MDCG)
Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD (MDCG)
Guidance on interpretation of significant changes (Canadian CA)
Clinical Evaluation (IMDRF)
Clinical Investigation (IMDRF)
Clinical Evidence – Key definitions and concepts (IMDRF)
Summary of safety and clinical performance A guide for manufacturers and notified bodies – August 2019 (MDCG)
Interpretation of Article 54(2)b rev 1 (MDCG)
Interpretation of Article 54(2)b (MDCG)
Anleitung für Sponsoren: Klinische Prüfung (KP) und Leistungsbewertungsprüfung (LP) (DIMDI)

MDR - Timeline

It shall apply from 26 May 2021. Derogations in MDR Article 123. 3

Mainly MDR Article 120 and Article 123

Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC (MDCG)
Transition Timelines from the Directives to the Regulations – MD and IVD Devices
TEAM-NB List of on line check for validity of certificates

MDR - Special categories

Single-use devices – In particular MDR Article 17, Annex I 23.2. (n), 23.4. (p), Annex VI Part C 3.9

Systems & Procedure packs – In particular MDR Article 22, 29.2., Annex VI Part C 3. 7., 6.3.,

Custom-made devices – In particular MDR Article 10.5., 15.1., 21, 52.8., 86.1., Annex I 23.2. (p), 23.3. (g), Annex XIII

Investigational devices – In particular MDR Article 15.3. (e), 21, 52.13., 62.4. (l), 70.7., 71.3., 80, Annex XV

Software – In particular Annex I 14.2., 17, 23.4., Annex II 1.1.j, 6.1., Annex VI Part C, Annex VIII 3.3.-3.4., Mainly Rule 11

Device with a medicinal substance – In particular MDR Article 1.8.-9. 4.4.,54.1.b, 71.3g, 7., 89.6., 117, Annex I 10.3., 12, 23.2., 23.4. s & t, Annex II 6.2., Annex VI, , Annex VIII Rule 6,8,12, 14, 20, Annex IX 5.2.,5.4, 6, Annex XI 8, 16, Annex XIII, Annex XV 1.10, 2.6.

Devices without a medical purpose MDR – In particular Article 1.2.-5., Annex XVI

Implantable devices – In particular MDR Article 10.8., 18, 27.8-9., 32, 52.4-5.& 8., 54.1, 61.4.& 6.& 8.& 11, 86.2., 108, 123.3. (f) (g), Annex I 19., 23.2. (s), 23.4. (f), Annex VI 2.14., 6.1., Annex VIII Rule 8, 9, 15, Annex IX 5.1., 7., Annex X 7., Annex XI 9., 17., Annex XIII 4. , Annex XV 3.15. , Chapter III 3.

Checklist for EN 17466 & Validation (Instructions for use for reusable & re-sterilisable medical devices (COEN) – MDD only
Transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product […] as well as on devices manufactured using TSE susceptible animal tissues (MDCG)
MDCG Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software (IVDR) (MDCG)
MDCG Guidance on Cybersecurity for medical devices (MDCG)
Principles and Practices for Medical Device Cybersecurity (IMDRF)
Personalized Medical Devices – Regulatory Pathways (IMDRF)
European Medicines Agency Questions & Answers on Implementation of MDR and IVDR (EMA)
MDCG Guidance on Qualification and Classification of Software (MDCG)
ANSM (French authority) Guideline – Cybersecurity of medical devices integrating software during their life cycle
1-pager on Software and Artificial Intelligence (SNITEM)
MHRA Guidance for manufacturers on Annex XVI devices (MHRA)

MDR - Standards

‘harmonised standard’ means a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012;

Mainly MDR Article 8, 9, 99, Annex II 4.

Commission Notice – The annual Union work programme for European standardisation for 2021 (EC)
Draft standardisation request as regards medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
Meeting of the STANDARDS sub-group of MDCG (Minutes from 19.06.2020)
Commission Implementing Decision C(2020) 2532 of 15.5.2020 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization as regards medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746 of the European Parliament and of the Council
IMDRF Standards Checklist modified in scope of COVID-19
Commission Implementing Decision (EU) 2020/437 of 24 March 2020 on the harmonised standards for medical devices drafted in support of Council Directive 93/42/EEC
Commission Implementing Decision (EU) 2020/438 of 24 March 2020 on the harmonised standards for active implantable medical devices drafted in support of Council Directive 90/385/EEC
Draft standardisation request as regards medical devices in support of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
ISO 14971:2019 Medical devices — Application of risk management to medical devices
Online Browsing Platform (ISO)

IVDR - UDI

‘Unique Device Identifier’ (‘UDI’) means a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market;

Mainly IVDR Article 10.6., 10.8.(h), 13.2.(d), 14.2.(d), 24-26, 29.2. (a), 30.2. (b), 55, 84.8., 87, 111, Annex I 20.2. (g), Annex II 1.1., Annex IV 2.3-4., Annex VI, Annex XII Chapter 1

Unique Device Identification (UDI) System – FAQs (European Commission)
MedTech Europe Guidance on Basic UDI-DI (MedTech Europe)
Guidance on BASIC UDI-DI and changes to UDI-DI (MDCG) – V3
GS1 (UDI Issuing entity) contacts
GS1 Basic UDI-DI and GS1 UDI HRI & AIDC Formats
IFA Basic UDI-DI and IFA UDI HRI & AIDC Formats
HIBCC Basic UDI-DI and HIBCC UDI HRI & AIDC Formats
ICCBBA Basic UDI-DI and ICCBBA UDI HRI & AIDC Formats
UDI related responsibilities of distributors and importers under MDR Article 16 (MDCG)
Unique Device Identification (UDI) (MDCG – Working Group 9)
UDI Database, Definitions/Descriptions and formats of the UDI core elements (UDIWG)
The architecture of the UDI database – Basic UDI-DI and UDI-DI attributes (UDIWG)
Guiding principles for issuing entities rules on Basic UDI-DI (MDCG)
Language issues associated with UDI database (MDCG)
UDI Assignment to Medical Device Software (MDCG)
Guidance on UDI for systems and procedure packs (MDCG and Annex)
Guidance on Basic UDI-DI and changes to UDI-DI (MDCG) – v2
UDI System Application Guide (IMDRF)
1-pager on UDI (SNITEM)

GS1

10 step UDI plan (GS1)
Latest brochure on UDI in Europe (GS1)
Executive summary about the GMN standard (GS1)
GMN standard update (GS1)
GMN check calculator (GS1)
GMN Helper library (GS1)
GMN management guidance regarding mergers and acquisitions Position Paper (GS1)
Search engine for GTINs owners (GEPIR, Global Electronic Party Information Register) (GS1)
GTIN check digit calculator (GS1)
GS1 Healthcare GTIN allocation rules (GS1)

IVDR - Standards

‘harmonised standard’ means a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012;

Mainly IVDR Article 8, 29.2. (d), 67, 99-100, Annex I 20.1.(h), Annex II 4 (c), Annex VII, Annex IX 2.2.-3., Annex X 3., Annex XII, Annex XIII 1.1., 5.2., Annex XIV 2.2, 2.7.

Commission Notice – The annual Union work programme for European standardisation for 2021 (EC)
Draft standardisation request as regards medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
Meeting of the STANDARDS sub-group of MDCG (Minutes from 19.06.2020)
Commission Implementing Decision C(2020) 2532 of 15.5.2020 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization as regards medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746 of the European Parliament and of the Council
IMDRF Standards Checklist modified in scope of COVID-19
Commission Implementing Decision (EU) 2020/439 of 24 March 2020 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Directive 98/79/EC of the European Parliament and of the Council
Draft standardisation request as regards medical devices in support of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
Online Browsing Platform (ISO)

IVDR - Timeline

It shall apply from 26 May 2022. Derogation in IVDR Article 113. 3

Mainly IVDR Article 110 and 113

Transition Timelines from the Directives to the Regulations – MD and IVD Devices

MDR - CE

‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing;

Mainly MDR Article 10.6, 13.2., 14.2.,20, 21-23, 74, Annex V

COMMISSION RECOMMENDATION (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat

IVDR - CE

‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing;

Mainly IVDR Article 10.5., 18, 19, 70, Annex V

IVDR - Post-Market Surveillance

‘post-market surveillance’ means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;

Mainly IVDR Articles 10.8-9., 15.3, 56.6, 78-87, 110.3., Annex I 3., Annex III, Annex XIII

WHO Implementation of post-market surveillance for manufacturers of medical devices,including in vitro diagnostic medical devices(IVDs), used in cervical cancer programmes (WHO)
WHO Guidance on post-market and market surveillance of medical devices including IVDs (WHO)
Questions and Answers document regarding the Implementation of the new Manufacturer Incident Report (MIR) Form (European Commission)
Manufacturer incident report 2020 (European Commission)
Manufacturer incident report for importing XML file with Adobe Professional 2020 (European Commission)
Changelog file 2020
Manufacturer incident report Helptext 2020 (European Commission)
IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (IMDRDF)

MDR - Common specifications

‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.

MDR Article 1 and 9

Commission Implementing Regulation (EU) 2020/1207 of 19 August 2020 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use devices

IVDR - Common specifications

‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.

IVDR Article 9

IVDR - Performance evaluation

‘performance evaluation’ means an assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device;

Mainly IVDR Articles 56, 78, Annex II 6.2., Annex VII 3.2.4.,4.5. -11., Annex IX, Annex X, Annex XIII

MedTech Europe Clinical Evidence Requirements for CE certification under the in vitro Diagnostic Regulation in the European Union (MedTech Europe)
Current performance of COVID-19 test methods and devices and proposed performance criteria – Working document of Commission services (EC)
Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software (MDCG)

MDR - Team-NB

Team-NB Position paper Directives expiring certificates –impacts and suggested solutions
Team-NB Position paper for the interpretation of device related changes in relation to a Notified Body Opinion as required under Article 117 of Medical Device Regulation (EU)2017/745
TEAM-NB Member-List-28
TEAM-NB List of on line check for validity of certificates
TEAM-NB and NB-MED White Paper – 1 Year of Application
Joint NB-Position Paper on Spinal Classification per the MDR

MDR - Position papers

Team-NB Position paper Directives expiring certificates –impacts and suggested solutions
Team-NB Position paper for the interpretation of device related changes in relation to a Notified Body Opinion as required under Article 117 of Medical Device Regulation (EU)2017/745
MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers (MDCG)
MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States
Team-NB Position Paper on the requirements for the EU MDR/IVDR Notified Body Partners under the Technical Cooperation Program on Exchange of Medical Device Quality Management System Regulation and ISO 13485 Audit Reports (TCP III)
MedTech Europe Position Paper on virtual MDR & IVDR audits during a pandemic
MedTech Europe Press Release on MDR postponement
Team-NB Statement MDR DoA postponement
TEAM-NB Position Paper on Documentation Requirements for Drug Device Combination Products Falling in the Scope of Article 117 of MDR 2017/745
COCIR supports economic operators under the Medical Device Regulation
COCIR Position paper: Implementing MDR
Team-NB Position paper on Dental Implants-20200311-V1
TEAM-NB and NB-MED White Paper – 1 Year of Application
Joint NB-Position Paper on Spinal Classification per the MDR

MDR - Guidance

Guidance on UDI for systems and procedure packs (MDCG) – Rev.1
Guidance on regulatory requirements for medical face masks (EC)
Transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product […] as well as on devices manufactured using TSE susceptible animal tissues (MDCG)
Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation (MDCG)
Guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions (MDCG)
Guidance on Basic UDI-DI and changes to UDI-DI (MDCG) – V3
Guidance document on implant card (MDCG) – V2
Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD (MDCG)
Guidance on Cybersecurity for medical devices (MDCG)
Guidance notes for manufacturers of Class I Medical Devices (MDCG)
Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation (MCDG)
Guidance document on Qualification and Classification of Software in MDR and IVDR (MDCG)
Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC (MDCG)
Summary of safety and clinical performance: A guide for manufacturers and notified bodies (MDCG)
Guidance document Implant Card (Article 18)
Guidance on “person responsible for regulatory compliance”- PRRC (MDCG)
EU Commission SCHEER guidelines (Scientific Committee on Health, Environmental and Emerging Risks) on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED properties)
Guidance on application of UDI rules to devices incorporating medicinal substance, human tissues and cells (MDCG)
Guidance on content of the certificates, voluntary certificate transfers(MDCG)
Draft guidance on Basic UDI-DI and changes to UDI-DI (MDCG)
Guidance on UDI for systems and procedure packs (MDCG and Annex)
Preliminary Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices
Blue Guide on EU Product legislation (EC)

IVDR - MDCG

Documents

2020-17 – Questions and Answers related to MDCG 2020-4 (MDCG)
2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (MDCG)
Ongoing Guidance development within MDCG Subgroups (MDCG)
2020-15 Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States (MDCG)
Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR) (MDCG)
2020-01 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software (IVDR) (MDCG)
2019-13 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation (MCDG)
Designating authority’s final assessment form: Key Information (EN) (MDCG)
Guidance document on Qualification and Classification of Software in MDR and IVDR (MDCG)
2019-7 Guidance on “person responsible for regulatory compliance” – PRRC (MDCG)
2019-6 Questions and answers: Requirements relating to notified bodies (MDCG)
2019-5 Registration of legacy devices in EUDAMED (MDCG)
2019-1 Guiding principles for issuing entities rules on Basic UDI-DI (MDCG)
2018-8 Guidance on content of the certificates, voluntary certificate transfers(MDCG)
2018-1 V3 Guidance on Basic UDI-DI and changes to UDI-DI (MDCG)
2018-1 V2 Guidance on Basic UDI-DI and changes to UDI-DI (MDCG)
2018-1 Draft guidance on Basic UDI-DI and changes to UDI-DI (MDCG)

Meetings (Agenda/Minutes)

Planned meetings of MDCG and subgroups for 2020
Meeting of MDCG (main group) – 07-08/12/2020 – Draft Agenda
Meeting of MDCG – IVD working group meeting – 16/11/2020 – Draft Agenda
Meeting of MDCG – Unique Device Identification working group meeting – 09/11/2020 – Draft Agenda
Meeting of MDCG – New Technologies working group – 23/10/2020- Draft Agenda
Meeting of MDCG – EUDAMED working group meeting – 19/10/2020 – Draft Agenda
Meeting of MDCG Nomenclature working group – 12/10/2020 – Draft Agenda
Meeting of the International Matters sub-group of the MDCG – 08/09/2020 – Draft Agenda
Meeting of the MDCG (MDR – IVDR) – 02/07/2020-Draft Agenda
Meeting of the STANDARDS sub-group of MDCG 19/06/2020
Meeting of the IVD sub-group of MDCG – Competent Authorities with Stakeholders 25/05/2020
Meeting between the MDCG and Stakeholders (MDR-IVDR) 12/03/2020 – Draft Agenda
Meeting of the MDCG (MDR/IVDR) 11/03/2020- 12/03/2020 – Draft Agenda
High level meeting of the MDCG (MDR/IVDR) 11/03/2020 – Draft Agenda
Meeting of the UDI sub-group of MDCG (MDR – IVDR) 17/02/2020 – Draft Agenda
Meeting of the MDCG (MDR – IVDR) 13/12/2019 – Draft agenda
Meeting (extraordinary) of the MDCG (MDR – IVDR) 21/11/2019 – No public minutes
Meeting of the MDCG (MDR – IVDR) 01/10/2019 – No public minutes
Meeting between the MDCG and stakeholders 30/09/2019 – No public minutes
Meeting of the MDCG (MDR – IVDR) 20/06/2019
Meeting of the STANDARDS sub-group of MDCG 20/05/2019
Meeting of the MDCG (MDR – IVDR) 09/04/2019
Meeting of the NBO sub-group of MDCG 29/03/2019
Meeting of the PMSV sub-group of MDCG and stakeholders 05/03/2019
Meeting with stakeholders 14/02/2019 – No public minutes
Meeting (MDR – IVDR) 14/02/2019 – No public minutes
Meeting (MDR – IVDR) 30/11/2018 – No public minutes
Minutes (MDR – IVDR) – 11/10/2018
Meeting with stakeholders – 24/09/2018 – Minutes
Minutes (MDR – IVDR) – 24/09/2018
Minutes (MDR – IVDR)- 17/07/2018
Minutes (MDR – IVDR) – 02/05/2018
Minutes (MDR – IVDR) – 06/03/2018
Meeting with stakeholders – 05/03/2018 – Minutes

Procedural aspects

Rules of procedure of the MDCG
Terms of references of the MDCG Working Groups:
- MDCG Working Group 1: Notified Bodies Oversight (NBO)
- MDCG Working Group 2: Standards
- MDCG Working Group 3: Clinical Investigation and Evaluation (CIE)
- MDCG Working Group 4: Post-Market Surveillance and Vigilance (PMSV)
- MDCG Working Group 5: Market Surveillance
- MDCG Working Group 6: Borderline and Classification (B&C)
- MDCG Working Group 7: New Technologies
- MDCG Working Group 10: International Matters
- MDCG Working Group 11: In vitro diagnostic medical devices (IVD)

IVDR - Position papers

Team-NB Consideration paper on IVDR Date of Application
Biomedical Alliance in Europe Statement: Urgent action needed to ensure optimal implementation of the EU In Vitro Diagnostics regulation
Team-NB Position Paper on the requirements for the EU MDR/IVDR Notified Body Partners under the Technical Cooperation Program on Exchange of Medical Device Quality Management System Regulation and ISO 13485 Audit Reports (TCP III)
MedTech Europe Position Paper – Ensuring a successful transition to the new IVD Regulation in light of COVID-19
MedTech Europe Position Paper on virtual MDR & IVDR audits during a pandemic

MDR - Public consultations/Call for EOI

Blood, tissues and cells for medical treatments & therapies – revised EU rules (open from 17 November 2020 – 14 December 2020)
IMDRF Proposed update to document on Post-Market Clinical Follow-Up Studies (Consultation open until 11.12.2020)
Public consultation on the preliminary Opinion (open from 26.10. to 7.12.2020)
Declaration of interest (DOI) form – Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05) (EC)
IMDRF Consultation on Competence and Training Requirements for Regulatory Authority Assessors of Conformity Assessment Bodies conducting Medical Device Regulatory Reviews (Consultation open until 26.05.2020)
IMDRF Consultation on Regulatory Authority Assessment Method for Recognition and Surveillance of Medical Device Conformity Assessment Bodies (Consultation open until 09.05.2020)
European Commission Call for applicants to become observers to the Annex XVI sub-group of the MDCG (Call for applicants open until 28.02.2020)
IMDRF Principles and Practices for Medical Device Cybersecurity (Consultation open until 02.12.2019)
European Commission Call for Expression of Interest: Application form for Expert panels – (Open until 24.11.2019)
HPRA (Irish authority) on proposed human medicines & medical devices fees 2020 (Consultation open until 07.11.2019)
IMDRF Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies (Consultation open until 03.10.2019)
ANSM Guideline on the cybersecurity of medical devices integrating software (Consultation open until 30.9.2019)
IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) – Annex А (Edition 3), G (Consultation open until 10.9.2019)
EMA Guideline on the quality requirements for drug-device combinations (Consultation open until 31.8.2019)
European Commission Implementing Regulation concerning reprocessing of single-use medical devices (Consultation open until 20.8.2019)
Draft standardisation request as regards medical devices in support of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (Consultation open until 25.7.2019)
SCHEER Guidelines on phthalates in medical devices (Consultation open until 28.4.2019)

IVDR - Law

Proposal to extend the mandate of the European Medicines Agency (EC)
Proposal to extend the mandate of the European Centre for Disease Prevention and Control (EC)
Proposal for a Regulation on serious cross-border threats to health (EC)
Regulation on in vitro diagnostic Medical Devices (IVDR )
IVDR V2 Corrigendum
Commission Implementing Regulation (EU) 2017/2185: Designation of notified bodies (MDR/IVDR)

National implementing Acts

Austria: Gesamte Rechtsvorschrift für Medizinproduktegesetz, Fassung vom 23.03.2020
The Netherlands: Wet medische hulpmiddelen (Draft); Decree on medical devices
Germany: Gesetzes zur Anpassung des Medizinprodukterechts an die Verordnung (EU) 2017/745 und die Verordnung (EU) 2017/746 (Draft)
Slovenia: Uredba o izvajanju uredbe (EU) o medicinskih pripomočkih (Draft)
Croatia: Zakon o provedbi Uredbe (EU) 2017/745 o medicinskim proizvodima i Uredbe (EU) 2017/746 o in vitro dijagnostičkim medicinskim proizvodima
Serbia: Zakon o medicinskim sredstvima

IVDR - Guidance

Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (MDCG)
Ongoing Guidance development within MDCG Subgroups (MDCG)
Guidance on Performance Evaluation of Medical Device Software (MDCG)
Guidance on sampling of Class C devices for the assessment of the technical documentation (MCDG)
Designating authority’s final assessment form: Key Information (EN) (MDCG)
Guidance document on Qualification and Classification of Software in MDR and IVDR (MDCG)
Guidance on “person responsible for regulatory compliance” – PRRC (MDCG)
Questions and answers: Requirements relating to notified bodies (MDCG)
Registration of legacy devices in EUDAMED (MDCG)
Guiding principles for issuing entities rules on Basic UDI-DI (MDCG)
Guidance on content of the certificates, voluntary certificate transfers(MDCG)
V3 Guidance on Basic UDI-DI and changes to UDI-DI (MDCG)
V2 Guidance on Basic UDI-DI and changes to UDI-DI (MDCG)
Draft guidance on Basic UDI-DI and changes to UDI-DI (MDCG)
Blue Guide on EU Product legislation (EC)

MDR - Business associations

Swiss MedTech Guide on designating EC RP under MDR (French language) (German language)
MedTech Europe Document on Industry Perspective on the Implementation Status of the MDR/IVDR
MedTech Europe position on the proposed draft Standardisation Request for In-vitro Diagnostic Medical Devices (IVD) Regulation (2017/746/EU) and Medical Devices (MD) Regulation (2017/745/EU)
MedTech Europe Document on Implementation of the new MD and IVD Regulations: Industry Calls for Solutions to Ensure Continuity of Care to Patient
MedTech Europe MDR Transition
MedTech Europe Document on Implementation of the new IVD and Medical Devices Regulations – Transition Periods
MedTech Europe Document on Implementation of the new IVD and Medical Devices Regulations – Early availability & capacity of notified bodies
MedTech Europe Document on Implementation of the new IVD and Medical Devices Regulations – Resourcing and Governance
MedTech Europe MDR Flowchart on the new requirements

Something missing?

You cannot find what you are searching for? Let us know which MDR/IVDR tool you wish to see in order to comply, and we’ll do our best to deliver it.

MDR - Useful links

I. Standardisation

EU website on Medical Device standards partly providing presumption of conformity ( http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices/)
Irish Standardisation Body (to buy standards in English) http://www.standards.ie/cgi-bin/home_main/ie
Other national standardisation bodies (to buy standards in other languages) https://standards.cen.eu/dyn/www/f?p=CENWEB:5
CEN – European Committee for Standardisation (to search for new standards) https://www.cen.eu/Pages/default.aspx
CENELEC – European Committee for Electrotechnical Standardization (to search for new standards) https://www.cenelec.eu/
ISO – International Organization for Standardization (to search for new standards) https://www.iso.org/home.html
ISO Online Browsing Platform (search for ISO standards, graphical symbols, codes or terms and definitions https://www.iso.org/obp/ui/#home
IEC – International Electrotechnical Commission (to search for new standards) https://www.iec.ch/index.htm

II. Notified Bodies

http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34

III. Authorities

European Commission
EU Member States Authorities in charge of medical devices
NBOG (EU Member States’ Authorities in charge of Notified Bodies)
EFTA (European Free Trade Association) – status of MDR/IVDR

IV. European Business Associations

European Association of Authorized Representatives (representing non-EU manufacturers)
MedTech Europe (representing EU manufacturers or their national organisations, also for IVD)
COCIR – Radiological, Electromedical and Healthcare IT Industry
EUROM – European Federation of Precision Mechanical and Optical Industries
EUROM VI – European Industrial Federation Committee on Medical Technology
EHIMA – European Hearing Instrument Manufacturers Association
EUROMCONTACT – European Contact lens and lens care industry’s association
FIDE – Federation of European Dental Industry

V. International

International Medical Device Regulators Forum

IVDR - Useful links

I. Standardisation

EU website on Medical Device standards partly providing presumption of conformity ( http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices/)
Irish Standardisation Body (to buy standards in English) http://www.standards.ie/cgi-bin/home_main/ie
Other national standardisation bodies (to buy standards in other languages) https://standards.cen.eu/dyn/www/f?p=CENWEB:5
CEN – European Committee for Standardisation (to search for new standards) https://www.cen.eu/Pages/default.aspx
CENELEC – European Committee for Electrotechnical Standardization (to search for new standards) https://www.cenelec.eu/
ISO – International Organization for Standardization (to search for new standards) https://www.iso.org/home.html
ISO Online Browsing Platform (search for ISO standards, graphical symbols, codes or terms and definitions https://www.iso.org/obp/ui/#home
IEC – International Electrotechnical Commission (to search for new standards) https://www.iec.ch/index.htm

II. Notified Bodies

http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35

III. Authorities

European Commission
EU Member States Authorities in charge of medical devices
NBOG (EU Member States’ Authorities in charge of Notified Bodies)

IV. European Business Associations

European Association of Authorized Representatives (representing non-EU manufacturers)
MedTech Europe (representing EU manufacturers or their national organisations, also for IVD)
COCIR – Radiological, Electromedical and Healthcare IT Industry
EUROM – European Federation of Precision Mechanical and Optical Industries
EUROM VI – European Industrial Federation Committee on Medical Technology
EHIMA – European Hearing Instrument Manufacturers Association
EUROMCONTACT – European Contact lens and lens care industry’s association
FIDE – Federation of European Dental Industry

V. International

International Medical Device Regulators Forum

IVDR - Public consultations/Call EOI

Declaration of interest (DOI) form – Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05) (EC)
IMDRF Principle of In Vitro Diagnostic (IVD) Medical Devices Classification (Consultation open until 25.07.2020)
IMDRF Principles and Practices for Medical Device Cybersecurity (Consultation open until 02.12.2019)
European Commission Call for Expression of Interest: Application form for Expert panels
IMDRF Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies (Consultation open until 03.10.2019)
ANSM Guideline on the cybersecurity of medical devices integrating software (Consultation open until 30.9.2019)

IVDR - Special categories

Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software (IVDR) (MDCG)
Principles and Practices for Medical Device Cybersecurity (IMDRF)
Questions & Answers on Implementation of MDR and IVDR (EMA)
Guidance on Qualification and Classification of Software (MDCG)

MDR - MDlaw docs

Guidance/Templates prepared by our experts

IVDR - MDlaw docs

Guidance/Templates prepared by our experts

Case-law

RB v TÜV Rheinland LGA Products GmbH and Allianz IARD SA (11/06/2020)

Text from Judgment in Case C-581/18, PRESS RELEASE No 69/20

… as EU law currently stands, insurance covering the civil liability of manufacturers of medical devices with respect to harm linked to those devices is not the subject of regulation by EU law.

..the Court observed that the patient concerned did not make use of her freedom of movement, since she seeks payment of insurance compensation for harm caused by the insertion of breast implants in Germany, the Member State in which she resides, so that there is no specific connecting factor linking the situation at issue in the main proceedings and that freedom. Second, as regards the freedom to provide services, the Court noted that the situation at issue again has no specific connecting factor linking it to that freedom, since, in the first place, the patient concerned received medical treatment in the Member State where she resides and, in the second place, the insurance contract concerned was concluded between two companies established in one and the same Member State, in this instance France. Last, as regards the free movement of goods, the Court observed that the dispute in the main proceedings relates not to the cross-border movement of goods in itself, since the cross-border movement of the breast implants concerned was not affected by any discriminatory obstacle, but to the harm caused by the goods so moved. Consequently, the situation at issue again has no specific connecting factor linking it to free movement of goods.

First paragraph of Article 18 TFEU must be interpreted as meaning that it is not applicable to a clause, stipulated in a contract concluded between an insurance company and a manufacturer of medical devices, limiting the geographical extent of the insurance coverage against civil liability arising from those devices to harm that has occurred in the territory of a single Member State, since such a situation does not fall, as EU law currently stands, within the scope of application of EU law.

Key words: PIP, Free movement of goods and EU citizens, product liability, defective medical devices, territorial limitations, civil liability insurance coverage

RB v TÜV Rheinland LGA Products GmbH, Allianz IARD SA (06/02/2020)

”It was manifestly not the intention of the EU legislature to harmonise the Member States’ legislation regarding insurance against civil liability arising out of the use of medical devices…

The fact that the insurance does not ‘travel’ with the goods, even if it is compulsory in the home Member State for subsequent use of those goods in that Member State, is not an issue that is covered by either Article 34 or Article 35 TFEU (free movement of goods)…

The starting principle for the regulation of the internal market is respect for regulatory diversity in matters not explicitly harmonised by EU law…

It is also for the Member States, as EU law currently stands, to regulate insurance policies applicable to medical devices used on their territory, even when those devices are imported from another Member State. Member States are certainly free, in the absence of harmonisation, to decide to introduce a higher level of protection of patients and users of medical devices through more favourable insurance policies applying on their territory…”

Text of the AG Bobek Opinion

Key Words: product liability, defective medical devices, territorial limitations, insurance regime, EU 2017/745

Falcon Technologies International v Commission (5/12/2018)

Text of the Judgments (in French language)
Key Words: access to documents, notified body, commercial interest

Boston Scientific (25/10/2018)

”..the terms ‘medicinal product’ and ‘medical device’ are mutually exclusive in such a way that a product that falls within the definition of a ‘medicinal product’ within the meaning of Directive 2001/83 may not be classified as a medical device within the meaning of Directive 93/42 ”

“…the EU legislature intended to reserve the grant of SPCs to medicinal products alone, to the exclusion of both medical devices and substances used as adjuvant products of a medical device.” ”…the extension of the scope of that regulation to such substances would have the practical effect of enabling SPCs covering medical devices which incorporate those substances to be granted. Such a consequence would be contrary to the objective, referred to in recital 10 of Regulation No 469/2009, that the protection granted by an SPC must be strictly confined to the product which obtained MA as a medicinal product. ”

Text of the Judgments

Key words: medicinal product, function, patent, SPC

Junek Europ-Vertrieb v. Lohmann & Rauscher International (17/5/2018)

“Given that the packaging of the medical device concerned has not been modified and the original presentation of the packaging has not been affected other than by the attachment of a small label, which does not conceal the mark and which designates the parallel importer as responsible for placing it on the market by setting out his details, a barcode and a central pharmacological number, it cannot be held that the attachment of such a label constitutes repackaging within the meaning of the judgments Boehringer Ingelheim and Others”

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