DEKRA joins UK Approved Body list

The Medicines and Healthcare products Regulatory Agency (MHRA) recently confirmed the appointment of DEKRA Certification UK as an Approved Body for medical devices - making it the first organisation to obtain this designation since the new system was introduced after the UK’s withdrawal from the EU.

Approved Bodies play a vital role in assessing the conformity of medical devices against the requirements of the UK Medical Device Regulations 2002. With the exception of low-risk Class I devices, all manufacturers must obtain certification from an Approved Body before placing their products on the market in Great Britain.

DEKRA now joins three existing Approved Bodies - BSI Assurance UK, SGS United Kingdom and UL International - in being able to carry out this assessment. The type of devices that each of these organisations are able to assess varies. DEKRA is only permitted to issue certification for general medical devices (not in vitro diagnostic devices or active implantable devices). Its scope is also limited to applications for devices to be placed on the market in Great Britain (not Northern Ireland).

The MHRA hopes that DEKRA’s appointment will substantially increase “the UK’s capacity to process conformity assessments for medical devices”.^[1] This is an important priority post-Brexit as the UK is no longer able to rely on the EU’s larger network of Notified Bodies. That said, although the UK is currently experiencing an Approved Body bottleneck, the EU is also facing a similar challenge following the introduction of the EU Medical Device Regulations and In Vitro Device Regulations. Due to the more stringent requirements and limited conformity assessment capacity, medical device manufacturers in the EU have reported lengthy delays in the certification process.^[2]

The appointment of DEKRA is a welcome step towards addressing this issue for manufacturers in the UK. However, there is undoubtedly still room for more work to be done in increasing the UK’s capacity, especially as Brexit transition periods draw to a close and the number of manufacturers who will be required to obtain UK certification increases. 

We are also keeping an eye out for future Approved Body appointments - the MHRA has stated that there are currently six organisations progressing through the assessment process and it is actively engaging with others preparing their initial submissions.

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[1] MHRA Press Release, MHRA appoints first new UK Approved Body to certify medical devices since Brexit, 29 September 2022

[2] Team NB, Notified Body position paper on MDR/IVDR Implementation, 1 December 2021