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      Medical Device Regulation

      Information on the Medical Device Regulation

      The new European Medical Device Regulation (MDR) with many new rules is a challenge for all involved. B. Braun is preparing intensely and wants to apply the new requirements as soon as possible. Here we have compiled some information about the MDR for you.

      The new European Medical Device Regulation (MDR) went into force in May 2017. The new regulation replaces the existing Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD).    

       

      The current approx. 500,000 medical devices in Europe will be recertified in accordance with the new, substantially more comprehensive policy to receive the CE mark. According to current estimates, approximately only 65 percent of the medical devices will be certified according to the new regulation. Some notified bodies are still in the designation phase and it is not fully clear as to how many notified bodies will be able to conclude the process (list on European Commission website). Due to the increased requirements placed on the notified bodies and the manufacturers, portfolio adjustments are expected and are inevitable. 

       

      Implementation timeline of the MDR at B. Braun

      The MDR entered into force on May 25, 2017. Here is an overview of implementation related dates and periods. 

      May 2019 

      May 2019 

      Certification of B. Braun as manufacturer according to MDR 

      May 25, 2021

      May 25, 2021

      Mandatory MDR application

      May 26, 2024

      May 26, 2024

      Products must have a MDR application signed (except for MDD products being sold out)

      December 2028

      December 2028

      End of all MDD transition periods

      May 2021 – May 2027/2028

      May 2021 – May 2027/2028

      MDD certificate “grace period”: No design change for MDD certified products

      Until 2027 / 2028

      Until 2027 / 2028

      MDD certificates maintain validity (timeline depends on product risk class)

      General FAQs concerning the MDR

      FAQs concerning the MDR & B. Braun

      More information

      Here is a collection of useful links to information on official websites of the European Comission and other sources.