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MEC-ABC, Your „guide“ to
clinical data under MDR
Often a conversation helps more than looking for a solution on the Internet!
In particular, we provide support on the topics:
MEC-ABC supports developers and manufacturers of medical devices in determining and collecting clinical data for the development and approval, and for the entire life cycle of the medical device.
MEC-ABC acts as a guide, providing advice on how to understand and correctly apply the requirements.
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Challenges of the MDR (Medical Device Regulation)
On May 25, 2017, the EU Medical Device Regulation (MDR ) came into force together with the equally new IVD Regulation (In-vitro Diagnostic Device Regulation – IVDR ). Both form the new European regulatory framework for medical devices. They replace the previous guidelines (MDD, AIMD, IVD). The MDR is mandatory after a four-year transition period, starting May 26, 2021. There is a five-year transition period for the IVDR.
New requirements for MDR
Compared to the previous regulations, the MDR places a large number of new and stricter requirements on the manufacturers of medical devices. These concern
The MDR presents manufacturers with major new challenges:
All medical devices that are currently approved must be re-certified according to the new requirements.