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1 member likes this: John Sandham
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Thanks for the link.

From what I understand, for medical devices which have a CE mark, nothing much will change until 2023 (assuming that the manufacturers of those devices can obtain a CE mark - currently through the MDD, soon under the MDR).

Custom and in-house manufactured devices will need to meet the requirements of the UK 2002 Medical Device Regulations. I expect that these will be aligned with the EU MDR etc in due course once the new UK Medicines and Medial Devices Bill has been passed. There may however, at some point, be some divergence between the EU and UK medical device regulations. If/when this happens, manufacturers would have to comply with two different regimes to get access to both markets.

As stated in the guidance, there will be an additional requirement for medical devices to be registered with the MHRA following a certain grace period.

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That's right plus I hope it will bring job opportunities for the profession because somebody needs to evaluate or certify devices in the UK for the UK system. I note it is different for NI as they can still use CE marked devices - wise to read up on these aspects if you are in NI...... Interesting indication for GB/UK general regulations in the future as well

Last edited by Ian Chell; 01/01/21 1:24 PM.
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I would not hold out for many job opportunities, as approved bodies may be international companies with a UK registered office. All the assessment work will be undertaken at existing international locations and only the final paperwork will be passed via the UK office.

If every medical device had to be tested in an UK facility you would expect a reduced choice of products available in the UK market and they would be at an increased cost!


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