DEKRA has become the first organisation to complete the new designation process

The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that DEKRA Certification UK has now joined the three current UK-approved bodies, increasing the UK’s capacity to process conformity assessments for medical devices.

DEKRA has become the first organisation to complete the new designation process and is now designated to undertake assessments for general medical devices – known as ‘Part II designation’.

An approved body is an organisation that has been designated by the MHRA to assess whether manufacturers and their medical devices meet the requirements set out in the UK Medical Devices Regulations 2002.

With the exception of the very lowest risk devices, manufacturers must apply to a UK-approved body. Only after they have UK Conformity Assessed (UKCA) certification can their products be placed on the market in England, Wales and Scotland.

Ultimately, the MHRA’s detailed assessment process is designed to ensure that any organisations that wishes to certify medical devices are stable,able to undertake impartial and objective assessments, have an appropriate quality management system in place to support them, the resources to undertake the assessments and the processes and ongoing certification in place to meet the relevant regulatory requirements.

Following an appropriate assessment, the approved body will issue relevant certification allowing manufacturers to place a UKCA marking on their products before putting them on the market.

Dr Laura Squire, chief healthcare quality and access officer at the MHRA, explained: “This is a major milestone in our mission to ensure patients across the UK have access to the high-quality medical devices they need to protect their health.

“Approved bodies play a critical role in the supply of medical devices and expanding capacity is vital to the successful development of the UK’s medical device regulatory regime. This has been a significant piece of work and our teams have worked extremely hard to get to this stage,” she added.

Meanwhile, there are a further six organisations which are currently in the assessment process and there is active engagement with several further organisations who are preparing to submit their initial submission.