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 How EUDAMED will affect medical device manufacturers

How EUDAMED will affect medical device manufacturers

By Qiang Kou (KK)

March 14, 2022


The EUDAMED database provides a living picture of the lifecycle of medical devices available in the EU to address regulatory challenges and clinical studies.

EUDAMED stands for the European Database on Medical Devices, a secure web-basedportal operated by the European Commission to centralise information pertaining to medical devices available on the EU market. Its primary goal is to ensure traceability and transparency in order to uphold the stringent regulatory requirements facing the healthcare and life sciences sector.

EUDAMED comprises six modules, which together provide a living record of the lifecycles of medical devices sold in the EU. Of these, three modules are now available. The remaining three modules are expected to become active during 2022.

Why do we need EUDAMED?

EUDAMED improves transparency and coordination of information regarding medical devices sold on the EU market. As a collaborative and interoperable platform, it functions as a registration system and an information dissemination system, which is partially open to the public. This makes it possible to effectively monitor the safety and performance of any medical devices used in the bloc to address regulatory challenges and enhance healthcare overall.

Medical device regulation is vital to public health and safety, and EUDAMED aims to improve that. For example, a lack of regulatory oversight can and has in the past led to major scandals, such as when the now-defunct French company Poly Implant Prothése (PIP) sold thousands of illegal and unapproved silicone breast implants. Being an extended databases on medical devices that provides comprehensive and publicly available information, cases such as these are far less likely to happen with EUDAMED.

What kind of information does EUDAMED contain?

EUDAMED stores a wealth of information pertaining to medical devices that are approved for sale in the EU. Depending on the product classification and the relevant regulatory provisions, this information may contain some or all of the following:

  • The registrations of manufacturers and their authorised devices
  • Declarations of conformity with health and safety standards
  • A vigilance and traceability system with declarations or ISO certificates
  • Product labelling and usage instructions
  • Information on clinical investigations and other areas of life sciences

What are the implications of EUDAMED?

EUDAMED provides a valuable source of information on medical devices sold in the EU, not only for device manufacturers themselves, but also for any other applicable stakeholders. For device manufacturers and life sciences firms, the database can serve as a valuable source of information about new products on the market. To that end, it can facilitate innovation, reveal new market opportunities, and provide visibility into the devices, manufacturers, and stakeholders throughout the EU. Device manufacturers themselves must register their medical devices in the EUDAMED platform within 24 months of releasing them on the EU market.

As is the case with any database platform, scale is the biggest challenge when preparing for EUDAMED and leveraging it as a powerful informational resource. The size and complexity of the database ultimately means we need to apply modern solutions like machine learning and artificial intelligence to make sense of it all.

This will allow device manufacturers and other key actors to derive valuable insights from the wealth of information which will, in turn, allow them to address regulatory and medical device monitoring and lifecycle challenges. Being equipped with trusted intelligence on medical device data will ultimately result in better public health, and that is simply priceless. NyquistData’s AI-powered tools provide trusted intelligence on medical devices to help uphold regulatory demands and unlock hidden insights from unstructured life sciences data.

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