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.
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LAW
- Belgium: Loi relative aux dispositifs médicaux
- Sweden: Draft Act with supplementary provisions to EU regulations on medical devices
EUROPEAN COMMISSION
- COVID-19 Tests – Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19 (EC)
MDCG
- 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)
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)
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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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