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    BSI issues its 2000th medical devices regulation (MDR) certificate

    Achievement ensures timely access for safe and effective medical devices globally 

    30 April 2025: BSI, a leading global Notified Body (NB), has issued its 2000th certificate under the EU Medical Devices Regulation (MDR). This achievement confirms BSI’s position as a trusted Notified Body, helping to ensure the timely market access for safe and effective medical devices across Europe and beyond.

    Certificates have been awarded to manufacturers in almost 50 countries. The 2000th certificate was issued in the US on 29th April. This achievement comes just four years after the EU’s more stringent regulation came into force. BSI issues approximately 500 MDR certifications annually and accounts for over 26% of all those issued by the now 50 designated notified bodies operating in this field.

    Dr. Haydar Jaafar, Operations Delivery Director, Medical Devices, BSI said: “Our continued success in issuing MDR certificates at scale, while upholding the highest of standards, underscores the passion and dedication of our entire team. Each certificate represents a step forward in patient safety and technological progress. 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, BSI added: “Issuing our 2000th MDR certificate is a powerful validation of the role BSI plays in shaping a safer and more efficient medical device ecosystem. I am immensely proud of the partnerships we have built and the innovations we’ve enabled to ensure the timely access for safe and effective medical devices.”

    To safeguard continued patient access to vital medical technologies, the EU has extended the MDR transition period until 2027 or 2028, depending on device classification. However, due to the rigorous and time-intensive nature of the certification process, BSI strongly encourages manufacturers not to delay their applications and submission plans, as to meet the demand for vital medical devices.