BSI issues its 1000th MDR certificate

[Contenuto in lingua inglese]

Date: 07 July 2023

BSI has achieved a significant milestone by issuing its 1000th Medical Devices Regulation (MDR) Certificate. This achievement accounts for over 30% of all certificates issued by the 38 notified bodies operating in this field and have been awarded to manufacturers in 40 countries, with the majority being granted to manufacturers in the USA, the UK, and China.

Dr Michael Weissig, Global Managing Director Medical Devices of BSI’s Regulatory Services (RS) division, said: “This achievement is a testament of the trust the medical devices industry has in BSI.” His colleague Haydar Jaafar, Operations Delivery Director of the same division, added: "This accomplishment highlights the outstanding achievement of all BSI colleagues. Their dedication has enabled BSI to achieve this success."

Under the new European Union Medical Devices Regulation (MDR), all new medical devices, as well as 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 European Union (EU). The MDR application process is more extensive and rigorous than its predecessors, 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.

BSI's 1000th MDR Certificate was issued to Xiros Ltd for a Class III implantable device, marking an exceptional achievement in the industry. 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. Suzanne Halliday, Vice President of Regulatory, emphasised the considerable effort required for the conformity assessments under the MDR: "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". While celebrating this achievement, 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 focussed on supporting its manufacturers in completing the work under the Directives including early renewals of their Directive certificates.”

To mitigate shortages of medical devices, the EU has extended the MDR transition period until 2027 or 2028, depending on the class of the medical device. However, considering the substantial work involved in the certification process, BSI urges manufacturers not to delay their applications and submission plans. Prompt action will aid compliance with the MDR and help meet the demand for vital medical devices.

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, which is approximately 50% of the total IVDR certificates more than any other Notified Body designated under IVDR.