With a March 2020 go live date, The European Database for Medical Devices (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 Requirements (MDR) are 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).

Readiness

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

 

If you’re ready to tackle these regulations, the Innovit team is here to help you meet the new challenges of EUDAMED and the wider MDR submissions. We are building on our experience by working with our global healthcare customers to design solutions for both structured data submissions and unstructured data.