Overview of published documents Jan-April 2021

To improve MDlaw experience and to keep you informed of all the relevant publications of the first four months of 2021, we present the below list of documents that are available in different sections/categories of our Library  of Documents:

EUROPEAN COMMISSION (MDR/IVDR)

  • Commission Implementing Decision C(2021) 2406 of 14.04.2021 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 (EC)
  • Implementation Rolling Plan April 2021 -(EC)
  • Is your software a medical device? (EC)
  • COVID-19 Tests – Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19 (EC)
  • Getting ready for the new regulations (EC)

Manufacturers MD (EC)

Manufacturers of devices without an intended medical purpose (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)

  • Factsheet for Manufacturers of Implantable Medical Devices (EC)
  • Experts panels – list established by the EC

MDCG

  • Ongoing Guidance development within MDCG Subgroups (MDCG)
  • 2018-1 Rev.4 Guidance on BASIC UDI-DI and changes to UDI-DI (MDCG)
  • 2021-6 Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation (MDCG)
  • 2021-5 Guidance on standardisation for medical devices (MDCG)
  • 2021-4 Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 (MDCG)
  • Planned Meetings of MDCG and subgroups – 2021 (MDCG)
  • 2021-3 Guidance Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices (MDCG)
  • 2021-2 Guidance on state of the art of COVID-19 rapid antibody tests (MDCG)
  • 2021-1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional (MDCG)
  • Meetings of MDCG and subgroups – 2021 (MDCG)
  • MDCG – Market Surveillance working group meeting – 28/04/2021 – Draft Agenda
  • MDCG – IVD working group meeting : Stakeholders & Competent Authorities session – 08/04/2021 – Draft Agenda
  • MDCG – IVD working group meeting : Competent Authorities session – 08/04/2021 – Draft Agenda
  • MDCG – Annex XVI working group meeting – 08/03/2021 – Minutes
  • Meeting of the MDCG (MDR – IVDR)  – 04/03/2021 – Final Draft Agenda and Final Minutes
  • Meeting between MDCG and the Stakeholders – 04/03/2021 – Final Draft Agenda and Final Minutes
  • Meeting of the MDCG (MDR – IVDR)  – 04/03/2021 – Final Draft Agenda
  • Meeting between MDCG and the Stakeholders – 04/03/2021 – Final Draft Agenda
  • EUDAMED Subgroup – 23/02/2021- Draft Agenda
  • Meeting of MDCG – NBO (Notified Bodies Oversight) working group meeting -05/02/2021 – Draft Agenda

NOTIFIED BODY

  • CORE-MD EU assessment of high–risk medical devices faces in–depth review (Team-NB)
  • Team–NB sector survey 2020 (Team-NB)
  • BSI White Paper: Software as a medical device – A comparison of the EU’s approach with the US’s approach (BSI)
  • BSI White Paper: Medical device clinical investigations – What’s new under the MDR? (BSI)
  • BSI White Paper: Machine learning AI in medical devices (BSI)
  • BSI White Paper: Sterilization – Regulatory requirements and supporting standards (BSI)
  • BSI White Paper: Risk management for medical devices and the new ISO 14971 (BSI)
  • BSI White Paper: Recent advancements in AI – implications for medical device technology and certification (BSI)
  • BSI White Paper: Responsible persons, authorized representatives and the new EU Regulations (BSI)
  • BSI White Paper: Comparison of the annexes of the MDD and the MDR (BSI)
  • BSI White Paper: Comparison of the articles of the European MDD and the MDR (BSI)
  • BSI White Paper: Digital maturity in an age of digital excitement (BSI)
  • BSI White Paper: Post-market surveillance under the MDR/IVDR (BSI)
  • BSI White Paper: Authorized Representatives under the MDR (BSI)
  • BSI White Paper: UDI and the MDR/IVDR (BSI)
  • BSI White Paper: Importers, distributors and assemblers (BSI)
  • BSI White Paper: Classification changes under the MDR (BSI)
  • 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)
  • Designation process: State-of-play (EC)

 LAW

  • Belgium: Loi relative aux dispositifs médicaux
  • Sweden: Draft Act with supplementary provisions to EU regulations on medical devices

COMPETENT AUTHORITY

  • BE – EUDAMED: Enregistrement des acteurs (AFMPS)
  • BE – Questions et réponses pour fabricants de Classe I concernant l’application du nouveau réglement rélatif aux dispositifs médicaux (AFMPS)
  • SI: Registracija gospodarskih subjektov v EUDAMED – Dokument z vprašanji in odgovori (JAMZP)

UK & SWITZERLAND

  • Contingency MedDO (Swiss MedTech)
  • Human Factors and Usability Engineering – Guidance on the regulation of  Medical Devices Including Drug-device Combination Products in Great Britain (MHRA)
  • Guidance – Designation of a Swiss Authorised Representative under the new MedDO (English language)
  • Swiss MedTech – information for the industry (MDR portal)
  • UK approved bodies for medical devices (MHRA)
  • Designated standards: medical devices (MHRA) & Designated standards: active implantable medical devices (MHRA)
  • Guidance: DEHP phthalates in 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)

STANDARDS

  • ISO 20417:2021 Medical devices — Information to be supplied by the manufacturer
  • 2021-5 Guidance on standardisation for medical devices (MDCG)
  • Commission Implementing Decision C(2021) 2406 of 14.04.2021 on a standardisation request in support of Regulation (EU) 2017/745 and (EU) 2017/746
  • ISO Research Library
  • MDCG Guidance on standardisation for medical devices (MDCG)
  • Commission Implementing Decision C(2021) 2406 of 14.04.2021 on a standardisation request in support of Regulation (EU) 2017/745 and (EU) 2017/746
  • New guidance on the sterilization of health care products (ISO)
  • BSI White Paper: Risk management for medical devices and the new ISO 14971 (BSI)
  • CEN and CENELEC Work Programme 2021 (CEN/CENELEC)
  • ISO 10993-23:2021 Biological evaluation of medical devices — Part 23: Tests for irritation

EUDAMED

  • MDCG 2021-1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
  • Mangement of legacy devices – MDR EUDAMED (EC) – 08.02.2021
  • SI: Registracija gospodarskih subjektov v EUDAMED – Dokument z vprašanji in odgovori (JAMZP)
  • BE – EUDAMED: Enregistrement des acteurs (AFMPS)

PUBLIC CONSULTATIONS

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