After the Brexit in Britain,Medical equipmentManufacturers’ sales of products in the UK market face unprecedented legal challenges. New regulations and standards are constantly being introduced, the most central of which is the UKCA certification system. For this we provide you with a comprehensive guide to UKCA certification.
1 UKCA certification
UKCA (UK Compliance Assessment) is a new standard for access to the UK medical device market, replacing the previous CE mark. For medical device manufacturers, it is crucial to ensure that products comply with the UK Medical Device Regulation (UK MDR).
Which products need certification?
All high-grade medical devices and in vitro diagnostic medical devices intended to be sold in the UK market are subject to UKCA certification. Whether new products or products already on the market must comply with this new regulation.
3 Who is entitled to certification?
Manufacturers must complete UKCA certification through a “UK Accredited Authority” whereas TüV Rheinland UK Ltd. has been recognized as a qualified authority for this work by the UK Drug and Health Products Administration (MHRA).
4 Certification process
The certification process covers product classification, review of technical documents, evaluation of quality management systems and final certification. All these steps ensure that the products meet the strict requirements of UKCA. In addition, Germany’s Rhein TüV can provide manufacturers with the necessary certification and testing services.
5 The time point.
While the UK government has provided a transition period for the UKCA, medical device manufacturers should pay attention to the extension limit of July 2023. Before that, manufacturers can choose the CE mark or the UKCA mark, or use both at the same time.
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