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May 26th 2017, critical day for Medical Devices in Europe

On May 5th 2017 the Official Journal of the European Union published the new Medical Devices Regulation (EU) 2017/45. According to the new Medical Devices Regulation the Regulation enters into force on May 26th 2017. The current legislation on medical devices, i.e. the Medical Devices Directive 93/42/EEC, will be repealed with effect from May 26th 2020. As such there will be a transitional period of three years for all parties concerned with medical devices to adjust their activities in order to comply with the new Medical Devices Regulation.

This means that until May 26th 2020 compliance with either the old Medical Devices Directive or the new Medical Devices Regulation is sufficient to bring a medical device onto the European market. After the aforementioned period of time compliance with the new Medical Devices Regulation is mandatory. However, please note that even though a product model or type has been supplied before May 26th 2020 in compliance with the old Medical Devices Directive, when individual units of the same model or type are placed onto the market after May 26th 2020 they must comply with the new Medical Devices Regulation.

The new Medical Devices Regulation is a regulation while the old Medical Devices Directive is a directive. The difference is that a regulation is directly applicable to all Member States while a directive first needs to be implemented in national legislation by the individual Member States.

Further, the new Medical Devices Regulation goes more in depth and is more descriptive. To give an indication, the old Medical Devices Directive entails about 60 pages and the new Medical Devices Regulation is about 175 pages. The new Medical Devices Regulation explains a lot more definitions which covers a broader scope of compliance procedures.

It could occur that with the entering into force of the new Medical Devices Regulation certain medical devices could be classified differently when classified according to the old Medical Device Directive. For example, an asthmatic inhaler would fall under Rule 5 of the old Medical Device Directive indicating that it is a Class I medical device where, when classifying the same inhaler in accordance with Rule 20 of the new Medical Devices Regulation it is classified, dependent on the intended use, as either a Class IIa or IIb medical device. Therefore it is essential for the parties concerned with medical devices to re-evaluate and re-classify the medical device in accordance with the new Medical Devices Regulation.

The essential requirements, to which medical devices must comply, are more extensive in the MDR. More attention goes to software, electronic safety of active devices and electronic means of supplying information.

Contact us to discuss the consequences of the new MDR via telephone (+31 (0)294 41 75 81) or e-mail info@ce-mark-medical.com.