What is MDR (Medical Device Regulation)?
MDR Eudamed is the new European Databank on Medical Devices. Eudamed has been in existence for many years but only accessible by the European Commission and the National Competent Authorities. Eudamed 2 has been processing device, certificates, NCARs and clinical investigations data for many years. It came into force in May 2011 (Regulation (EU) 2017/745).
New medical device regulations were adopted in 2017 by the EC, which include provisions to create a new application MDR Eudamed. This application is far larger and more ambitious than the previous application. The application will manage the data for:
- Devices (Unique Device Identifiers (UDI))
- Certification (e.g. CE markings)
- Clinical Investigations
- Manufacturers and importers — identified by a Single Registration Number (SRN)
- Notified Body accreditation and designation
- Extended vigilance data, including post-market surveillance
- Applications for conformity assessment by Notified Bodies
- Summaries of safety and clinical performance
- Performance studies for IVDs (like clinical investigations)
- Market surveillance data
MDR Eudamed Challenges
MDR Eudamed will be open to many more groups, EC, National Competent Authorities, Authorised Representatives, Notified Bodies, Manufacturers, Importers, and Sponsors. This list may increase. Current estimates are that this covers 70,000+ individual organisations, which could result in over 300,000 actual users.
From an IT perspective, this is a very ambitious project. Firstly the EC has to prepare a robust application to cover all stakeholder and legislative requirements. They must also provide machine-to-machine data transfer capabilities, meaning medical device companies (after successfully registering) will be able to upload all the required data automatically to the EC system. This is not a small task.
This EC system is not the only IT challenge. Companies wishing to use machine-to-machine facilities will have to run their own IT projects to prepare their data, set up and manage the data transport and all the potential issues that could arise. These will not be small projects and will require careful planning. While complicated, there will be help at hand. Companies like eudamed.eu are specialists in this type of work and project management. They will provide an abundance of services and assistance to make the transition to Eudamed 3 compliance as smooth as possible.
One of the biggest benefits of the new regulations and the EC project is the inclusion of a public site. The public will for the first time in Europe be able to research devices so they will be able to make informed decisions before proceeding with procedures. Doctors and other medical professionals will be better informed of any device related issues and the public will have access to the same data.
The FDA (Food and Drug Administration)
In the US, the FDA regulates the medical device market. It has put in place a public, searchable system, which does not cover as many classes of devices as the EC system. It gives valuable information to the public. When you see the few device classes the FDA covered in comparison to MDR Eudamed, you get an indication of how complex and ambitious the EC system will be.
MDR Eudamed is due to launch March 25th 2020; this does not leave much time for the EC to complete their work. For manufacturers and the other economic operators, time is even shorter. The EC already have their IT resources; others do not. Eudamed.eu can help with data compliance and the required data processing, validation and data delivery to MDR Eudamed. Our advice to all medical device manufacturers, sponsors, etc is to start working on these projects ASAP, they are not easy and market pressures for qualified IT staff have already started surfacing. Early preparation will mean you are ready on time. Late adopters will face major challenges.
If you wish to sell your medical devices in Europe, you and the devices must be in Eudamed.