The British Standards Institution (BSI) has issued the first UKCA mark under the country’s new legislation for medical devices.
The business standards company has approved the first UK product marking certificate for theatre instrument sets.
Under the UK MDR 2002 legislation for medical devices, BSI has issued the certificate through its newly designated UK Approved Body.
BSI regulatory services group director Manuela Gazzard 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.”
The UKCA certificate is the new UK product marking that is required to place in vitro diagnostics (IVDs) and medical devices on the market in Great Britain (England, Wales and Scotland).
BSI’s UK Approved Body head Jayanth Katta said: “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.”
