Article summary
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that DEKRA Certification UK Ltd has joined the three current UK Approved Bodies (BSI Assurance UK Ltd, SGS United Kingdom Ltd and UL International Ltd), which now increases the UK’s capacity to process conformity assessments for medical devices, ensuring the UK public has access to safe and efficient devices. DEKRA is the first organisation to complete the new designation process for the certification of medical devices in the UK since Brexit and is now approved to undertake assessments for general medical devices (Part II designation).
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