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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).    

 

In the future, 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 accreditation 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 implemetation related dates and periods. 

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May 2019 

May 2019 

Certification of B. Braun as manufacturer according to MDR 

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May 25, 2021

May 25, 2021

Mandatory MDR application

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May 26, 2024

May 26, 2024

Products must be MDR compliant when placed to the  market

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May 26, 2025

May 26, 2025

End of all MDD transition periods

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May 2021 – May 2024

May 2021 – May 2024

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

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May 2024 - May 2025

May 2024 - May 2025

Sale of MDD certified  products

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