Challenges of the new EU Medical Device Regulation (MDR)

Challenges of the new EU Medical Device Regulation (MDR)

2017 will be the introduction year of new EU regulation on medical devices. After becoming applicable, companies will have three years to implement the new rules and guidelines it brings.

The applicable regulations so far have been „93/42/EWG Medical Device Directive (MDD)“ and „90/385/EWG Active Implantable Medical Devices (AIMD)“.

The goal set by the authorities is to increase patient safety through higher quality and increased patient care levels, e.g. by trying to drive innovation at the medical device companies.

The regulation addresses naturally manufacturing companies, but also Regulatory Affairs Managers, EU-representatives, as well as importers and dealers.

In general, higher risk classes are on the way because of the regulation. Especially manufacturers of implantable products class III and class IIb combination products will have to do more in the future to bring their products onto the market.


Central Topics

  • Closer market surveillance, e.g. through increased unannounced audits by notified bodies
  • Establishment of traceability for products already on the market through a unique identification number (UDI)
  • This new traceability also gives companies the opportunity to improve and innovate their products
  • The availability of clinical data is planned to be improved, a positive development
  • The central data base, which will be established for that purpose will make it possible for all market participants to access comprehensive information about medical devices – be it the manufacturer, a notified body or patient(s) (organizations)
  • Also, participants in clinical studies of medical devices can expect higher patient safety


The press often talks about “fear” for the small and medium-sized medical device companies. They worry that the 3-year deadline to implement the new guideline will not be long enough for them to manage.

There are of course a lot of seminars and trainings about the new directive. Every medical device consultant working in the field of production, quality, regulatory affairs or patient safety should consider visiting them to have a good preparation for the challenges to come.

We are happy to support your Medical Device company, should you need temporary support through freelancers to cope with the challenges the new EU Medical Devices Regulation will bring.

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