Press release – MHRA appoints first new UK Approved Body to certify medical devices since Brexit

DEKRA Certification UK Ltd has now joined the three current UK Approved Bodies.

The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that DEKRA Certification UK Ltd has now joined the three current UK Approved Bodies, increasing the UK’s capacity to process conformity assessments for medical devices to ensure safe and effective devices reach the UK public.

DEKRA has become the first organisation to complete the new designation process that any potential organisation must now go through in order to become approved to certify medical devices in the UK. They are now designated as a UK approved body to undertake assessments for general medical devices (known as Part II designation).

Read the full news report here. Published on the 29th of September 2022.