The UK regulator responsible for our medical device industry, the MHRA, has recently announced that the entry into force of some medical device regulations will now be officially postponed by 12 months.
The current Medical Device Regulations (UK MDR 2002) state that the approval of CE-marked medical devices on the UK market ends on 30 June 2023. This has now changed. The UK transitional arrangements provide for an extension of the recognition of CE-marked medical devices on the UK market.
The MHRA (Medicines and Healthcare products Regulatory Agency) explains that the UK government intends to introduce legislation by spring 2023 that will bring the transitional arrangements and Post-market surveillance requirements into force. The reason for the postponement is to give manufacturers more time to fulfil the requirements that directly affect patient safety, among other things, under the future Medical Device Regulation. Supply bottlenecks for CE-labelled products on the British healthcare market are to be avoided in this way.
For manufacturers from the EU, this means that they can continue to market their CE-marked products in the UK after 1 July 2023.
If you have any questions about the transitional provisions or other regulatory requirements, please do not hesitate to contact the BEO BERLIN team.
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