The European Commission has adopted a proposal to postpone the application of the new Medical Devices Regulation (MDR), which was due to come into force on 26 May 2020. The decision means that the MDR will now apply one year later than originally planned, and will be effective from 26 May 2021. The new effective date falls after the end of the UK’s agreed transition period with the EU, which is due to end on 31 December 2020.
The MDR aims to improve the traceability features and safety management of medical devices sold within the EU. As a result, it places stricter requirements on manufacturers of certain medical devices to conform to the MDR’s standards by carrying out lengthier conformity assessments. Once the assessments have been carried out, manufacturers can place a CE mark on their product to show the requirements have been met.
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