Overview of published documents – February 2021

To improve MDlaw experience, and keep you informed of all the relevant documents of the previous month that have been collected in our Library  of Documents, we will be preparing such a notice on a monthly basis – available in our News section.


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


  • COVID-19 Tests – Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19 (EC)


  • 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

UK & Switzerland

  • 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)


  • 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)

Such an overview is available to all MDlaw members via the Monthly Newsletter. Please contact us at mdlaw@obelis.net in case you do not receive it in your mailbox, every end of the month.

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