Eudamed and MDR updates

Overview

The European Database for Medical Devices (Eudamed) is intended to serve as a repository for important clinical information about medical devices.  It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission.

With a March 2020 go‑live date, Eudamed will be open to many more groups, including manufacturers, importers and sponsors.  Current estimates are that this covers 70,000+ individual organizations and over 300,000 actual users.

Medical Device Regulation (MDR) are a set of new regulations aimed to enhance patient safety and modernize public health.  Key elements of the new MDR include the expansion of the definition of medical devices; enhanced vigilance, market surveillance and traceability measures; and a centralized EU database for the storage of information on medical devices (EUDAMED). Click here to read more about the regulatory framework.

The Timeline

One of the biggest benefits of these new regulations and this EUC project is the inclusion of a public site. Users will be able to research device information for better decision making before proceeding with procedures. Doctors and other medical professionals will be better informed of any device related issues whilst the public will have access to this useful data.

  • Q1 2019: Further functional testing
  • May 2019: Public site
  • September 2019: Eudamed is ready for the formal audit
  • March 2020: Eudamed goes live
  • March 2020 – September 2021: Eudamed must be filled with data on the rest of the devices placed on the European market

Readiness

If you’re a medical device company operating in the EU, then your ability to sell product is going to expire in early 2020 unless you meet the more stringent requirements of these new MDR regulations.

  • Aggregate your internal product master data from multiple sources into a single repository for data validation and submission
  • Create a complete “source of truth” that can be trusted by your customers, healthcare providers and the regulatory agencies!
  • Create a “Global Syndication Hub” that allows your company to scale the processes of Regulatory Compliance around the world.
  • Enrich & validate the product data based on the Eudamed -specific attributes, code value lists and validation rules
  • Submit your validated data to Eudamed using a solution partner that is experienced and proven in delivering MDR solutions that comply with Annex 11 and GAMP5 standards.

Fact Sheet for Medical Device Manufacturers (PDF)
No-Deal Brexit – Implications to MDR
Medical Device Regulations – Countdown
8 Things You Should Know about the EU MDRs