On April 5, 2017, the EU adopted the new Medical Device Regulation, replacing the two existing directives, the Medical Devices Directive and the Active Implantable Medical Devices Directive.
The new Medical Device Regulation will enter into force after a three-year transition period ending on May 25, 2020. This means that the market access framework for all member countries of the European single market (28 EU member states including the UK, the members of the EEA – Iceland, Lichtenstein and Norway, and through bilateral treaties Switzerland) will change significantly.
The aim of the new Medical Device Regulation is to address some inherent weaknesses in the old directives as well as the swift evolution of science and technology in the field of medical devices. To do so, it introduces several key improvements, among them:
Manufacturers need to start preparing now to make sure their products are compliant by May 25, 2020. Here’s how to get started:
Obtaining the CE-mark for your medical device takes you one step closer to entering the European healthcare market
Our experts take care of the process for obtaining the CE-mark so that you can concentrate on your core competencies.
Here is how the Lexium CE-Assistance work:
Please contact us for more information on our services and why you should choose Lexium as your CE assistance.
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