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BSI issues 1500th medical devices regulation (MDR) certificate

Milestone signifies BSI’s growth and commitment, ensuring medical devices are safe for use by clinicians and patients

18 June 2024: 1500 certificates have been issued under the European Union Medical Devices Regulation (MDR) by BSI, the business improvement and standards company, making it the first Notified Body to reach this significant marker. This milestone underscores BSI's unwavering commitment to ensuring timely market access for safe medical devices across Europe and beyond, while maintaining the highest standards of regulatory compliance.

Certificates have been awarded to manufacturers in over 40 countries, with the majority coming from the US, the UK, and China. The 1500th certificate was issued in the USA on June 17th. This achievement comes just 12 months after BSI issued its 1000th certificate and three years after the EU’s more stringent regulation came into force. BSI’s certifications now account for over 20% of all those issued by the now 49 notified bodies operating in this field.

Dr. Suzanne Halliday, Vice President of Regulatory Services, BSI said: I want to congratulate my colleagues for this remarkable achievement.  Some of the most recently issued certificates cover products with no medical purpose under Annex XVI and others cover appropriate surveillance under Article 120 to support EU 2023/607.  We also continue to utilise the opportunity of issuing certificates with conditions to support innovative and orphan devices.”

Dr. Haydar Jaffar, Operations Delivery Director Medical Devices, BSI commented, "Issuing 1500 MDR certificates marks a pivotal moment and highlights our mission to ensure timely market access to safe medical devices for European patients and beyond while upholding the highest standards of regulatory compliance. Crucially, it helps to give patients and healthcare professionals confidence in the devices they are using every day."

Dr. Michael Weissig, Global Managing Director Medical Devices Regulatory Services, BSI said: "Reaching this milestone of the 1500th MDR certificate shows again the leading role we play in the regulatory landscape of the medical devices sector. I am proud of our ongoing efforts to facilitate the successful market entry of innovative medical devices manufacturers, ensuring they meet the rigorous standards as set by the EU Medical Devices Regulations."

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.

Conformity assessments involve 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.

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