Month: April 2023

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SwissMedic: EU MDR/IVDR Amendments Accepted

Following the amendments made to the transitional provisions in the EU MDR and IVDR, SwissMedic in Switzerland has announced that they will be honouring the extended timelines and provisions introduced in the EU. See the full statement here: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/market-access/abgelaufene_bescheinigungen.html

EU Parliament

European Commission: MDR and IVDR Amendments Q&A

The European Commission has published a document which covers common questions being asked about the new MDR and IVDR transitional provision amendments. It answers the following questions: Full Q&A Document: https://health.ec.europa.eu/system/files/2023-03/mdr_proposal_extension-q-n-a_0.pdf

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AI Regulation Overview Brochure

The Council of Europe have released an insightful brochure laying down the existing work and relevant entities involved in regulating AI which you may access at the following link: https://rm.coe.int/brochure-artificial-intelligence-en-march-2023-print/1680aab8e6 Artificial Intelligence (AI) is affecting and disrupting most industries. Whilst this can be good, regulation is required to assure information and job security. This brochure …

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