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 ability to handle medical device conformity assessments to to ensure that safe and effective devices reach the UK public.
DEKRA has become the first organization to complete the new designation process which any prospective organization must now follow in order to be approved to certify medical devices in the UK. They are now designated as an approved body in the UK to undertake assessments for general medical devices (known as a Part II designation).
A Notified Body is an organization which has been appointed 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 very low risk devices, manufacturers must apply to an approved body in the UK. It is only after obtaining UKCA certification that their products can be marketed in England, Wales and Scotland.
Following an appropriate assessment, the approved body will issue relevant certification allowing manufacturers to affix a UKCA mark to their products before placing them on the market.
Dr Laura Squire, MHRA Healthcare Quality and Access Manager, said:
This is a major milestone in our mission to ensure that patients in the UK have access to the high quality medical devices they need to protect their health.
Approved Bodies play a vital role in the supply of medical devices and expanding capacity is essential to the successful development of the UK’s medical device regulatory regime. It has been a lot of work and our teams have worked extremely hard to get to this stage.
The MHRA’s detailed assessment process is designed to ensure that all organizations wishing to certify medical devices are stable, are able to undertake unbiased and objective assessments, have an appropriate quality management system in place to support them, have the resources to undertake the assessments, and the processes and ongoing certification in place to meet the relevant regulatory requirements.
There are six other organizations that are currently in the evaluation process and there is active engagement with several other organizations that are preparing to submit their initial submission.
Medical devices: organizations approved in the United Kingdom
Notes to Editors
- DEKRA Certification UK Ltd has joined the three current Approved Bodies: BSI Assurance UK Ltd, SGS United Kingdom Ltd and UL International Ltd.
- Between September and November 2021, the Medicines and Healthcare Products Regulatory Agency (MHRA) consulted on proposed changes to the regulatory framework for medical devices in the United Kingdom (UK). The proposals, together with the response to the consultation and the government’s response, have been published.