New approved bodies designated for UK medical device certification

For the majority of medical device types, except those deemed to be of very low risk, manufacturers are required to seek UKCA certification through a UK approved body. This certification is a prerequisite for placing products on the market in England, Wales and Scotland.

The three newly designated UK approved bodies, ‘TÜV SÜD’, ‘Intertek’, and ‘TÜV Rheinland UK’, were selected to evaluate and certify general medical devices. TÜV Rheinland UK's designation also covers the assessment and certification of in-vitro diagnostic products.

Louise Fullwood, medical intellectual property expert at Pinsent Masons, said: “Implementation of the UKCA mark for medical devices has been delayed a number of times in the past – in large part because of the relatively small number of UK approved bodies for carrying out conformity assessments.”

“Dekra, for example, was appointed in 2022, as just the third UK approved body. At that time, a further six organisations were currently going through the approval process and the MHRA was said to be in discussions with several other potential candidates. The industry will be keen to avoid further delays, because uncertainty over UKCA implementation can cause serious planning problems for medical device manufacturers,” Fullwood said.

She added: “Because of this, the MHRA’s latest announcement is good news. Three new approved bodies should help to ensure that the current timetable for UKCA implementation can be relied upon, allaying concerns that it could be delayed by ministers yet again.”

To ensure the integrity and capability of approved bodies, the MHRA undertakes a comprehensive assessment process before designating them, evaluating their ability to perform impartial and objective conformity assessments; the presence of a suitable quality management system; their capacity and competence for conducting assessments; and their adherence to relevant regulatory requisites.

Once the designation is successfully granted, the MHRA maintains oversight of UK approved bodies' operations. This oversight involves regular audits as well as observation of some of the bodies' audits of manufacturers.