BSI issues the first UKCA certificate under the new UK regulation for Medical Devices and IVDs
News: 29 January 2021
World’s first Medical UKCA (United Kingdom Conformity Assessed) certificate
BSI today announces 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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BSI is the business standards company that enables organizations to turn standards of best practice into habits of excellence, ‘inspiring trust for a more resilient world’. For over a century BSI has driven best practice in organizations around the world. Working with 84,000 clients across 195 countries, it is a truly global business with skills and experience across all sectors including automotive, aerospace, built environment, food and retail and healthcare. Through its expertise in Standards and Knowledge Solutions, Assurance Services, Regulatory Services and Consulting Services, BSI helps clients to improve their performance, grow sustainably, manage risk and ultimately become more resilient.