MDR - Law
- 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: Avant-projet de la Loi relative aux dispositifs médicaux (Draft)
- 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 - Clinical evaluation
- 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)
IVDR - MDCG
Documents
- 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)
- Ongoing Guidance development within MDCG Subgroups (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)
- 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
- Planned meetings of MDCG and subgroups for 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)
MDR - MDCG
Documents
- 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)
- Ongoing Guidance development within MDCG Subgroups (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)
- 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
- Planned meetings of MDCG and subgroups for 2020
- 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)
IVDR - Health Professionals and Health Institutions
MDR - Position papers
- 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
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
MDR - Public consultations/Call for EOI
- Public consultation on the preliminary Opinion (open from 26 October to 7 December 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)
MDR - European Commission
- 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
- 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 – FAQs
- MDR and IVDR – Infographics
- Implementation Model for MDR – Step by Step Guide (November 2018)
- Factsheet for the Procurement Ecosystem of MD and IVDs
- Step by step MDR Implementation model (July 2018)
- New rules to ensure safety
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MDR - UK & Switzerland
Switzerland
- Swiss MedTech Guide on designating EC RP under MDR (French language) (German language)
- Swiss MedTech Notice to manufacturers (French language)
UK
- Readiness notice for industrial products (EC)
MDR - EUDAMED
- Fact sheet on MDR requirements for Transparency and Public Information (EC)
- The CND Nomenclature (EC) – basis for the future EMDN
- 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 - UDI
- 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
- 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 - UDI
- 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
MDR - Notified Body
- 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)
- 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 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)
IVDR - Notified Body
- 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)
- 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)
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
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
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
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
IVDR - Standards
- 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)
MDR - Standards
- 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 - EUDAMED
- Fact sheet on MDR requirements for Transparency and Public Information (EC)
- 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
IVDR - European Commission
- Fact sheet on MDR requirements for Transparency and Public Information (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 - Special categories
- 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)
IVDR - Position papers
- 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
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)
MDR - Post-Market Surveillance
- 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)
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
IVDR - MDlaw docs
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)
Case-law
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
”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…”
Key Words: product liability, defective medical devices, territorial limitations, insurance regime, EU 2017/745
Text of the Judgments (in French language)
Key Words: access to documents, notified body, commercial interest
”..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. ”
Key words: medicinal product, function, patent, SPC
“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”
Key words: trademark, parallel import, packaging, label
” …software, of which at least one of the functions makes it possible to use patient-specific data for the purposes, inter alia, of detecting contraindications, drug interactions and excessive doses, is, in respect of that function, a medical device within the meaning of those provisions, even if that software does not act directly in or on the human body..”
“…the EU legislature intended to focus, in order to classify software as a medical device, on the purpose of its use and not the manner in which the effect it is capable of producing on or in the human body is likely to materialise…”
Key words: software, classification, medical devices
“Member States are not required to apply a reduced VAT rate to specific products in Annex III, point 3, to the VAT Directive”
Key words: Principle of fiscal neutrality, VAT, oxygen concentrators
“Under the MDD, no direct responsibility of a notified body for a culpable infringement vis-à-vis the final user, however the civil responsibility (compensation) can be triggered by the national law”
“When there is due cause – in the face of evidence indicating that a medical device may not comply with the legal requirements – the notified body has the obligation to examine such a medical device, the manufacturer’s business records and make unannounced inspections.”
Key words: conformity, liability, notified body, breast implants, Class III
“No need for additional conformity assessment by the parallel importer if a medical device bears a CE marking “
Key words: CE marking, parallel import, Class I
“The production of up to 100 packages of medicinal product for human use per day, carried out in a pharmacy as part of the normal pharmacy business, cannot be considered as manufactured by a method involving an industrial process. Thus, the Directive 2001/83 does not apply.”
Key words: medicinal product, industrial process
“No repackaging or putting device on the market “under his own name”, if the importer only attaches the label and the instructions for use in the official language of the Member State of importation”
“No right of the manufacturer of an diagnostic device to be notified in advance of a parallel import solely because of the fact that that device bears a CE marking.”
“No need for additional conformity assessment by the parallel importer of an medical device bearing a CE marking who translates the labelling and the instructions for use to the official language of another Member State to adapt them to the final user”
Key words: labelling, language, safe-guard clause, in-vitro medical devices, parallel trade
“Corrective colour contact lenses featuring designs are not a cosmetic product, notwithstanding the fact that their outer packaging bears the statement ‘cosmetic eye accessory, subject to the EU Cosmetics Directive’.”
Key words: contact lenses, cosmetics
“If a pacemaker or an implantable cardioverter defibrillator belongs to a group or production series having a potential defect, such a product is classified as defective without the need to establish that the product has a defect.”
“For a defective pacemaker, the damage covers the costs related to the replacement of such a defective product, for which the producer is liable.”
“For an implantable cardioverter defibrillator, it is for the national court to decide whether the deactivation of the magnetic switch is sufficient for the purpose of overcoming the defect in that product.”
Key words: defective product, replacement, pacemaker, implantable cardioverter defibrillator
“Indications to determine a medical purpose of a product: Use intended by the manufacturer and treatment carried out in an authorised medical centre and under the supervision of a practitioner.”
“The dimensions, weight and technology used are not decisive factors for the classification of goods”
Key words: goods, nomenclature, classification, intended purpose, medical purpose
“It is for national courts to verify the legality of prohibition decisions on placing a medical device on the market taken by the national authorities in this connection.”
“Alleging that the Commission should, of its own initiative, have commenced a safeguard clause procedure in relation to the effecto device – it must firstly be held- that this is a misinterpretation of the division of powers between the Commission and the Member States.”
Key words: health, conformity, omission, safeguard procedure
Remark: Under the new Regulation, so called “safeguard clause procedure” is governed by Article 95.
“A product bearing a CE marking can be a medical device in one Member State and qualified as a medicinal product in another – on the basis of its pharmacological, immunological or metabolic action.”
Key words: classification, medicinal product
Remark: Under the new Regulation, Article 4 (Regulatory status of products) prescribes that the Commission shall – after consulting the Medical Device Coordination Group – by means of implementing acts determine whether or not a specific product is a medical device. In addition, the Commission has the obligation to ensure the sharing of expertise among the Member States in order to determine the appropriate regulatory status of a product.
“Exclusive personal use v.general use devices”
“Annex III to the Directive 2006/112 does not authorise a reduced rate of VAT to be applied to medical devices which, viewed objectively, can be used only to prevent, diagnose, treat, alleviate or cure human or animal illnesses or ailments, but which are not intended for the exclusive personal use of the disabled.”
Key words: reduced VAT, personal use
“Medical use is inherent to the medical devices.”
“The concept of a ‘medical device’ covers an object conceived by its manufacturer to be used for human beings for the purpose of investigation of a physiological process only if it is intended for a medical purpose.”
Key words: medical purpose, medical use
“The products with pharmacological action classified as a medicinal product: as well as the pharmacological, immunological or metabolic properties of the product in question, which constitute the factor on the basis of which it must be ascertained whether it may be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions, account must be taken, in determining whether a product falls within the definition of a medicinal product ‘by function’ for the purposes of that provision, of all the characteristics of the product, including, inter alia, its composition, the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail.”
Key words: demarcation, cosmetics, pharmacological action
“General prohibition to sell contact lenses via the Internet is not proportionate to the objective of ensuring the protection of public health under the EU law.”
“E-commerce directive applies to certain aspects of selling contact lenses online- except rules related to the supply of those products.”
Key words: e-commerce, general ban, contact lenses
“Medical devices bearing the CE marking are considered to meet the essential requirements referred to in Article 3 of the Directive.”
“National legislation under which the commercial exportation of dental amalgams containing mercury and bearing the CE marking is prohibited on grounds relating to protection of the environment and of health is not compatible with the EU law.”
Key words: CE marking, protection of environment, protection of health
Infringement on the side of Greece for the administrative practice of consistent and general nature of directly rejecting public supply contract of medical devices fulfilling the requirements of the European Pharmacopoeia technical standard.”
Key words:public tender, hospital supplies
“A product cannot be regarded as a medicinal product where, having regard to its composition – including its content in active substances – and if used as intended, it is incapable of appreciably restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action.”
Key words: medicinal product, demarcation
“In order to assess the similarity of goods or services, all the relevant features of the relationship which could exist between them should be taken into account. Those factors include, in particular, their nature, their intended purpose, their method of use and whether they are in competition with each other or are complementary.” “As regards the material for stopping teeth and dental wax, they are in competition with the medical devices covered by the earlier mark and are complementary to the surgical and medical apparatus also protected by the earlier mark.”
“The global assessment of the likelihood of confusion, as far as concerns the visual, aural or conceptual similarity of the marks in question, must be based on the overall impression given by the marks, bearing in mind, in particular, their distinctive and dominant components.
Key words: trade mark, similarity
Public tendering for devices that must comply with the European Pharmacopoeia and bear the CE marking: 1. “The principle of equal treatment and the obligation of transparency preclude a contracting authority from rejecting, directly on grounds of public health and without following first the safeguard procedure, if the devices comply with the stated technical requirement.” 2. “The contracting authority needs to suspend such a tendering procedure. However, the authority is entitled to take all interim measures required to enable it to procure the materials necessary for the smooth running of that hospital.”
“Once those devices comply with the harmonised standards and are certified in accordance with the procedures provided for by that directive, they must be presumed to comply with those essential requirements and therefore be deemed to be appropriate for the use for which they are intended. In addition, these medical devices must benefit from free movement within the Union.”
“The presumption of compliance of medical devices can, however, be rebutted.”
Key words: public tender, CE marking, compliance, technical inadequacy, safeguard procedure, public health
“The obligation to state the registration number on the external packaging and to mention that registration on the notice accompanying each medical reagent is not proportionate with EU law.”
Key words: packaging, registration, reagent
IVDR - Clinical evaluation
- 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)
EUDAMED Webinar by Sandra Ferretti
MDR - Manufacturer
- 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)
MDR - Authorised Representative
- 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
IVDR - Guidance
- 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)
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IVDR - Law
- 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
MDR - CE
- COMMISSION RECOMMENDATION (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat
MDR - Notice for Manufacturers
- 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
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MDR - Timeline
- 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
MDR - Competent Authorities
- 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
IVDR - Business associations
- 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 IVDR 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 IVDR Flowchart on the new requirements
MDR - Distributor
- Guide for Distributors of Medical Devices (HPRA – Irish competent authority)
- SNITEM MDR Summary for Distributors
IVDR - Distributor
MDR - Health Professionals and Health Institutions
MDR - Team-NB
MDR - Importer
MDR - Other applicable law
I. Old EU law on medical devices which remains applicable under MDR
Commission Regulation (EU) No 722/2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin
Commission Regulation (EU) No 207/2012 on electronic instructions for use of medical devices
IV. Old EU law on medical devices applicable to some medical devices covered by valid Directive-certificates until April 2025 (end of transition period), see Article 120(3) and (4), Article 122 of the Regulation on Medical Devices
Reclassification of hip, knee and shoulder joint replacements:
Directive 2005/50/EC – OJ L 210/41 of 12.08.2005
Reclassification of breast implants:
Directive 2003/12/EC – OJ L 28/43 of 04.02.2003
Notified Bodies and their audits
-
Commission Implementing Regulation (EU) No 920/2013 – OJ L 523 of 25.09.2013
-
Commission Recommendation of 24 September 2013 – OJ L 253/27 of 25.09.2013
Electronic instructions for use of medical devices
Commission Regulation (EU) No 207/2012 – OJ L72 of 10.03.2012
Medical devices manufactured utilising tissues of animal origin:
Variant Creutzfeld-Jakob Disease assays:
Commission Directive 2011/100/EU – OJ L341/50 of 22.12.2011
Common Technical Specification on IVD:
Eudamed – European Databank on Medical Devices:
II. Other EU law possibly applicable to devices falling under the MDR (+ guidance)
This section contains EU law which is not specific to medical devices, but which might be applicable to some medical devices. Please note that:
– further regulations and directives than those listed here might be applicable;
– no definitive statement on the applicability or non-applicability can be made here.
The question of applicability of law to medical devices is particularly tricky. A definitive clarification covering all cases cannot be provided by this or any other website.
All statements refer to the relationship between the Regulation on Medical Devices and other EU law, unless explicit reference is made to the Directive on Medical Devices. The result would mostly, but not always identical for the relationship between the Directive on Medical Devices and other EU law.
The results may also partly differ for the Regulation on In vitro diagnostic Medical Devices.
Directive 85/374/EEC on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products
Consumer products
Directive 2001/95/EC on general product safety (see this Guidance)
Directive 2011/83/EU on consumer rights
Devices put into service on distance by internet or other electronic services
Directive 2000/31/EC on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market
Devices using energy
Legislation on energy efficiency and energy labelling, see this Overview
Devices which are machinery
Annex I to Directive 2006/42/EC on machinery is applicable via references from Medical Devices Regulation and Medical Devices Directive. The fulfilment of the requirements of this Annex I is examined in the medical devices conformity assessment procedure; other parts of the Machinery Directive do not apply.
Devices which are also measuring and weighing instruments
Directive 2014/32/EU on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments
Devices referring to measurement units
Directive 80/181/EEC on the approximation of the laws of the Member States relating to units of measurement
Devices problematic under aspects of occupational safety
Various directives could apply. See OSHA-page for overview; and in particular the following:
Devices emitting electromagnetic fields
Directive 2013/35/EU on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields)
Radio emitting devices
Directive 2014/53/EU on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment
Low voltage devices covered by Annex XVI of the Regulation on Medical Devices (as from the entry into application of respective Common Specifications); but not devices with a medical purpose
Directive 2014/35/EU on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits
For EU law on waste and in particular electronic and electric waste, see here; see also the navigation bar on the left of the page, linking to further legislation on waste.
Electric / electronic devices with hazardous substances
Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment
Devices using particular chemicals
REACH (see also further links on this site)
Classification, labelling, packaging of chemicals (see also further links on this site)
Devices using radioactive substances
Directive 2013/59/Euratom laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation
Legislation on human medicines (applicable via reference from Medical Devices Regulation and Medical Devices Directive)
Legislation on human tissues (applicable via reference from Medical Devices Regulation and Medical Devices Directive)
Directive 2004/10/EC on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances
References to this Directive are e.g. contained in the law on medicines, see above.
Regulation (EU) 2016/425 on personal protective equipment – the legislator has intended that either this Regulation or medical devices law applies
Regulation (EU) 1223/2009 on cosmetic products – the legislator has intended that either this Regulation or medical devices law applies
Regulation (EC) No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety – the legislator has intended that either this Regulation or medical devices law applies
Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products – see Article 2(2)(b) of that Regulation
Directive 2014/30/EU on the harmonisation of the laws of the Member States relating to electromagnetic compatibility – see Article 2(3) of this Directive and Article 1(11) of the Regulation on Medical Devices
III. Old EU law which remains applicable under MDR + Guidance
applicable to some medical devices until April 2025 (end of transition period); partly also applicable to new law:
- Borderline and Classification Manual
- Other European Commission guidance
- Guidance adopted by NBOG (Authorities in charge of Notified Bodies)
- Ireland
- United Kingdom
IVDR - Notice for Manufacturers
- 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 - Team-NB
- …
IVDR - Importer
- …
IVDR - Authorised Representative
IVDR - Competent Authorities
IVDR - Other applicable law
I. Old EU law on medical devices which remains applicable under MDR
Commission Regulation (EU) No 722/2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin
Commission Regulation (EU) No 207/2012 on electronic instructions for use of medical devices
IV. Old EU law on medical devices applicable to some medical devices covered by valid Directive-certificates until April 2025 (end of transition period), see Article 120(3) and (4), Article 122 of the Regulation on Medical Devices
Reclassification of hip, knee and shoulder joint replacements:
Directive 2005/50/EC – OJ L 210/41 of 12.08.2005
Reclassification of breast implants:
Directive 2003/12/EC – OJ L 28/43 of 04.02.2003
Notified Bodies and their audits
-
Commission Implementing Regulation (EU) No 920/2013 – OJ L 523 of 25.09.2013
-
Commission Recommendation of 24 September 2013 – OJ L 253/27 of 25.09.2013
Electronic instructions for use of medical devices
Commission Regulation (EU) No 207/2012 – OJ L72 of 10.03.2012
Medical devices manufactured utilising tissues of animal origin:
Variant Creutzfeld-Jakob Disease assays:
Commission Directive 2011/100/EU – OJ L341/50 of 22.12.2011
Common Technical Specification on IVD:
Eudamed – European Databank on Medical Devices:
II. Other EU law possibly applicable to devices falling under the MDR (+ guidance)
This section contains EU law which is not specific to medical devices, but which might be applicable to some medical devices. Please note that:
– further regulations and directives than those listed here might be applicable;
– no definitive statement on the applicability or non-applicability can be made here.
The question of applicability of law to medical devices is particularly tricky. A definitive clarification covering all cases cannot be provided by this or any other website.
All statements refer to the relationship between the Regulation on Medical Devices and other EU law, unless explicit reference is made to the Directive on Medical Devices. The result would mostly, but not always identical for the relationship between the Directive on Medical Devices and other EU law.
The results may also partly differ for the Regulation on In vitro diagnostic Medical Devices.
Directive 85/374/EEC on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products
Consumer products
Directive 2001/95/EC on general product safety (see this Guidance)
Directive 2011/83/EU on consumer rights
Devices put into service on distance by internet or other electronic services
Directive 2000/31/EC on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market
Devices using energy
Legislation on energy efficiency and energy labelling, see this Overview
Devices which are machinery
Annex I to Directive 2006/42/EC on machinery is applicable via references from Medical Devices Regulation and Medical Devices Directive. The fulfilment of the requirements of this Annex I is examined in the medical devices conformity assessment procedure; other parts of the Machinery Directive do not apply.
Devices which are also measuring and weighing instruments
Directive 2014/32/EU on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments
Devices referring to measurement units
Directive 80/181/EEC on the approximation of the laws of the Member States relating to units of measurement
Devices problematic under aspects of occupational safety
Various directives could apply. See OSHA-page for overview; and in particular the following:
Devices emitting electromagnetic fields
Directive 2013/35/EU on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields)
Radio emitting devices
Directive 2014/53/EU on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment
Low voltage devices covered by Annex XVI of the Regulation on Medical Devices (as from the entry into application of respective Common Specifications); but not devices with a medical purpose
Directive 2014/35/EU on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits
For EU law on waste and in particular electronic and electric waste, see here; see also the navigation bar on the left of the page, linking to further legislation on waste.
Electric / electronic devices with hazardous substances
Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment
Devices using particular chemicals
REACH (see also further links on this site)
Classification, labelling, packaging of chemicals (see also further links on this site)
Devices using radioactive substances
Directive 2013/59/Euratom laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation
Legislation on human medicines (applicable via reference from Medical Devices Regulation and Medical Devices Directive)
Legislation on human tissues (applicable via reference from Medical Devices Regulation and Medical Devices Directive)
Directive 2004/10/EC on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances
References to this Directive are e.g. contained in the law on medicines, see above.
Regulation (EU) 2016/425 on personal protective equipment – the legislator has intended that either this Regulation or medical devices law applies
Regulation (EU) 1223/2009 on cosmetic products – the legislator has intended that either this Regulation or medical devices law applies
Regulation (EC) No 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety – the legislator has intended that either this Regulation or medical devices law applies
Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products – see Article 2(2)(b) of that Regulation
Directive 2014/30/EU on the harmonisation of the laws of the Member States relating to electromagnetic compatibility – see Article 2(3) of this Directive and Article 1(11) of the Regulation on Medical Devices
III. Old EU law which remains applicable under MDR + Guidance
applicable to some medical devices until April 2025 (end of transition period); partly also applicable to new law:
- Borderline and Classification Manual
- Other European Commission guidance
- Guidance adopted by NBOG (Authorities in charge of Notified Bodies)
- Ireland
- United Kingdom
IVDR - Timeline
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