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Guidance for health institutions on in-house manufacture and use

Michael Ayers

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With the new EU Medical Device Regulations no longer becoming retained EU law within the UK (following Brexit), regulation of medical devices will largely revert back to the requirements set out in the old EU Medical Devices Directive (for now at least). One of the consequences of this is that medical devices manufactured and used within a single health institution will continue to fall outside the scope of the UK regulations.

With this in mind, IPEM have developed best practice guidance on manufacturing medical devices within health institutions. It can be found through the following link:

IPEM > Scientific Journals & Publications > Free Publications
 
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