MHRA: DEKRA appointed first new UK Approved Body to certify medical devices since Brexit
DEKRA Certification UK Ltd has become the first organisation after Brexit to complete the new designation process that any potential organisation must go through to become approved to certify medical devices in the UK. With this step taken it is now designated as a UK approved body to undertake assessments for general medical devices (known as Part II designation) and has joined the three current UK Approved Bodies BSI Assurance UK Ltd, SGS United Kingdom Ltd, and UL International (UK) Ltd. These three bodies had been approved before Brexit.
Manufacturers of most devices need to obtain certification from a body such as DEKRA to sell products in England, Scotland and Wales. According to the MHRA there are a further six organisations who are currently in the assessment process and there is active engagement with several further organisations who are preparing to submit their initial submission.
Source:
MHRA: Medical Devices Regulation and Safety
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