13 July 2023
UK – 1,000 certificates, confirming that medical devices are safe for use by clinicians and patients, have now been issued by BSI, the business improvement and standards company, under the terms of the new European Union Medical Devices Regulation (MDR).
The issuing of BSI’s 1000th MDR Certificate comes two years after the EU’s more stringent regulation came into force. BSI’s certifications now account for nearly a third of all those issued by the 38 notified bodies operating in this field.
Independent assessment of the conformity of a medical device to a particular standard Certification is required for all devices, although manufacturers can choose which notified body to partner with. It is a vital tool to give patients confidence that everything from pacemakers to defibrillators or cochlear implants are safe and help bring trusted life-saving technologies to market safely.
Certificates have been awarded to manufacturers in 40 countries, with the majority coming from the US, the UK, and China. The 1000th certificate was issued to Xiros Ltd for a Class III implantable device, marking an exceptional achievement in the industry. Reaching this milestone highlights BSI's mission to ensure timely market access to safe medical devices for European patients and beyond while upholding the highest standards of regulatory compliance.
Dr Michael Weissig, Global Managing Director Medical Devices, BSI, said: “This achievement is a testament of the trust the medical devices industry has in BSI.”
All new medical devices, including those previously certified under the Active Implantable Medical Devices Directive (AIMDD) and Medical Devices Directive (MDD), must comply with the requirements of MDR to be placed on the market in the EU. The MDR application process is more extensive and rigorous, covering the entire product lifecycle, and with several new requirements introduced in areas such as clinical evaluation, post-market surveillance, labelling including implant cards, and traceability.
To mitigate shortages of medical devices, the EU extended the MDR transition period until 2027 or 2028, depending on the class of device. However, considering the substantial work involved in the certification process, BSI urges manufacturers not to delay their applications and submission plans, in order to meet the demand for vital medical devices.
Dr Suzanne Halliday, Vice President of Regulatory, BSI, said: "I commend my colleagues for reaching this remarkable milestone and am proud of their dedication and hard work. Our staff had to learn about and assess against a new regulation in the background of a continuously evolving regulatory landscape with new guidance being published at a rapid pace".
BSI continues to lead the way in conformity assessments against the rigorous MDR requirements. By supporting the certification process, BSI assists manufacturers in successfully navigating the extended transition period, while safeguarding the availability of medical devices.
Beyond these MDR certificates, BSI has issued more than 70 Notified Body Opinion reports under Article 117 of the MDR. BSI has also made significant progress on the In Vitro Diagnostic Medical Device Regulation (IVDR) by issuing more than 220 IVDR certificates, approximately 50% of the total and more than any other Notified Body designated under IVDR.
Conformity assessments involves an audit of a manufacturer’s quality system and, depending upon the classification of the device, a review of the relevant technical documentation provided by the manufacturer in support of the safety and performance claims for the device. The technical documentation is assessed against the General Safety and Performance Requirements set out within the MDR.
Once the notified body has determined a manufacturer has conformed to the MDR, BSI provides a conformity assessment certificate to the appropriate directive.
Dr Jayanth Katta, Head of the Medical Devices Notified Body, added: “The milestone is even more significant considering that the focus of the Notified Body shifted to MDR work in earnest only after the date of application of the MDR in May 2021. Until then, BSI was heavily focused on supporting its manufacturers in completing the work under the Directives including early renewals of their Directive certificates.”
