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DEKRA Accredited To Audit Against UKCA Marking, But More UK Capacity Needed

First post-Brexit UK approved body receives designation

 
• By Ashley Yeo

A fourth approved body has been accredited to audit medical device submissions against the UKCA marking. A fifth is thought to be not far behind, but current assumptions are that overall auditing capacity will not be adequate under the forthcoming UK medical device regulations.

A stack of legal books with "Regulations" on the spines.

DEKRA Certification UK has been accredited to audit UK medical device applications under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended). The company’s approved body (AB) status was confirmed by the Medicines and Healthcare products Regulatory Agency (MHRA) on 2 September.

It joins BSI Assurance UK and SGS UK (both for devices and in vitro diagnostics) and UL International (IVDs only) in having conformity assessment body (CAB) status in the UK....

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