The prohibition of misleading claims arising from Article 7 MDR was implemented as a criminal offence in the Netherlands

As we all know, the Medical Device Regulation (EU) 2017/745 will be fully implemented as of May 2020 and concerns are being raised not only about the requirements of the new regulation but also on the implementing acts of the Member States.

The Regulation will be binding and directly applicable to all Member States of the European Union who are also allowed to adopt implementing acts to detail the application of the MDR.

In the particular case of the Netherlands, the Dutch implementing act will be more punitive than the Regulation in some respects and especially regarding misleading claims or misleading information in advertisement but also on the label, instructions for use etc.

According to the Dutch implementing act, misleading claims which are prohibited by the Article 7 of the Regulation will be punished by steep penalties as a non-compliance with the requirements of European law.
Indeed, such infringements (as well as general compliance infringement) will be prosecuted and punished with a high administrative penalty fixed by the Article 23 of the Dutch Criminal Code which will reach up to 10% of the manufacturer’s previous year’s turn over.

This shows the aim of the European Union and its Member States to achieve a safer market for the consumers and the end users of medical devices that can be found on the internal market by pushing for more substantiation of claims and more clarity to avoid any possible misleading for the consumer.

The Netherlands case is an example and a signal that many legal obligations might follow from national implementation of the Medical Device Regulation.

If you wish to know more about the Medical Device Regulation and national implementing acts, please do not hesitate to contact us.

Obelis Expert Consultants, with more than 30 years of experience with EU Regulations, will gladly answer any question you may have and will assist you in safeguarding your products’ compliance.

Manon Prado

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