Non-compliant medical devices: what are the risks?

December 14, 2020

Risks in the event of non-compliance of your medical devices

The new medical devices regulation aims to improve market transparency in Europe, product traceability, and consumer safety. Having a non-compliant device on the market exposes you to many risks.

A financial loss

In particular, the financial loss related to non-compliance is consequential. Potential financial penalties from the authorities have to be taken into account here, but not only! The recall of a product, for example, can lead to significant costs. Finally, lawsuits may be initiated by consumers: the expenses linked to this type of incident are substantial.

Risks related to brand image

Your company's image can quickly be affected by a non-compliant MD. The press quickly grasps this type of subject, and the emergence of numerous consumer associations enables consumers to exchange information more easily and quickly. All this is, of course, facilitated by digital tools and their multiplication in recent years.

Sanctions by Member States

The Member States of the European Union have until 21st February 2021 to notify the European Commission of the penalties and sanctions they will apply in the event of non-compliance with Regulation 2017/745. These sanctions may be financial penalties or even product withdrawals or recalls. We will come back to you towards the end of February with the specific elements.

MDR: evolving obligations

Economic operators under Regulation 2017/745 on medical devices have many obligations. To avoid ending up with a non-compliant device, you should, among other things, make sure that:

  • the device is designed, manufactured and produced in accordance with the requirements and the QMS (Quality Management System)
  • the device and the economic operator are registered on EUDAMED
  • the CE marking and the attribution of the UDI (Unique Device Identifier) are compliant
  • etc.

To find out in detail your requirements, we invite you to watch the replay of our webinar. EcoMundo can assist you in bringing your devices into compliance on the European market.

Wish to know more about medical devices?

For more information, do not hesitate to contact Raïssa Abdel Kader or one of our experts!

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