Wednesday, February 21, 2024

BSI Issues First UKCA Certificate Under the New UK Regulation for Medical Devices and IVDs

BSI has announced that it has issued its first UKCA certificate under the UK MDR 2002 legislation for medical devices via its newly designated UK Approved Body (0086). The first UKCA certificate covers theatre instrument sets.

The UKCA mark is the new UK product marking that will be required for in vitro diagnostics (IVDs) and medical devices being placed on the market in Great Britain (England, Wales, and Scotland). BSI is an expert in European and UK market access requirements, and with one of the widest ranges of market access solutions, our team brings years of industry experience and expertise.

Dr Manuela Gazzard, Group Director of Regulatory Services at BSI, said: “We are truly proud to be issuing the world’s first conformity certificate under the new UK legislation for medical devices. We are committed to supporting the UK market and playing our role in ensuring the supply of safe medical devices to patients in the UK.”  

Dr Jayanth Katta, Head of the UK Approved Body at BSI, added: “Being the first company to achieve full-scope designation under the UK legislation for our UK office and under the IVDR and MDR for our office in The Netherlands means that we can offer a complete service to our clients. We are delighted to have issued the first UKCA certificate for medical devices under the new UK Regulation. The new requirements have meant additional obligations on manufacturers and conformity assessment bodies; the BSI team has shown extraordinary dedication in preparing and rolling out UKCA certification activities in a short time frame.”

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