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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:
Clinical evaluation
Medical devices must be safe and perform well. To prove this, a clinical evaluation is required
Clinical trials
If insufficient clinical data are available, own clinical data must be collected.
PMCF
Post-market surveillance (PMS) of medical devices.
Clinical evaluation
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 medical devices themselves,
- the technical documentation,
- Classification, approval and placing on the market,
- as well as some other topics
Manufacturer obligations
The MDR presents manufacturers with major new challenges:
- By expanding the definitions, the scope of the MDR is considerably extended.
- Clinical evaluation is now a continuous lifecycle process.
- There are further or fundamentally changed processes;
- The classification rules as well as the conformity assessment procedures have been changed.
- Much higher requirements are placed on the availability/collection of clinical data and on clinical evaluation.
- For the post-market surveillance of medical devices by the manufacturer, the new MDR imposes strict and comprehensive requirements (Post Market Surveillance System);
- Further changes in the registration in the European medical device database EUDAMED.
All medical devices that are currently approved must be re-certified according to the new requirements.