Providing greater transparency for patients and Healthcare Professionals [HCPs] is at the heart of the new EU Medical Devices Regulation (EU MDR).

The European Database on Medical Devices (EUDAMED), once fully functional, will power this transformation by providing access to greater information about products at the click of a button.

This is a significant change for healthcare professionals (HCPs) and patients. Here are five things to know about the database which is central to our industry’s new EU MDR operating environment…

  1. EUDAMED is an integral part of EU MDR and will, once fully operational, provides a living picture of the lifecycle of medical devices that are made available in the EU.
    EUDAMED integrates different electronic systems to collate and process information about medical devices and related companies (e.g., manufacturers). In doing so, EUDAMED enhances overall transparency by providing greater access to information for patients and HCPs and aims to enhance coordination between the different Member States in the EU.
  2. EUDAMED has both public and secure access. Patients and HCPs will be able to view the extensive information registered in the different modules and available on the public pages of EUDAMED. They will be able to search for data related to devices, their manufacturers, certificates of conformity, Notified Bodies, clinical investigations, incident reports and more. The restricted site is accessible to medical device manufacturers, authorised representatives, importers, and other stakeholders located in the EU and globally.
  3. EUDAMED provides access to the new Summary of Safety and Clinical Performance (SSCP) for high-risk devices. The public will have access to the SSCP which is targeted also to patients to have an easy understanding of the clinical data used to ensure a device is safe, and to establish performance expectations in the market plan. The section targeted to patients is written in simplified terms, suitable for members of the public who do not have a background in healthcare.
  4. EUDAMED is a collective responsibility, with the relevant stakeholders (including manufacturers like Johnson & Johnson MedTech) required to make accurate data available in the necessary modules to be compliant with EU MDR.
  5. EU MDR places more emphasis on a life-cycle approach to safety, including post-market surveillance (PMS), vigilance, and post-market clinical follow up. The six modules in EUDAMED reflect this, they are:
    • Economic Operators (Actors) Registration
    • UDI & Device Registration
    • Notified Bodies & Certificates
    • Clinical Investigations
    • Vigilance & Post-Market Surveillance
    • Market Surveillance

Want to know more about EUDAMED?

As a trusted partner, JJMT will support you to understand the transition to EU MDR. Visit our EU MDR resources page for factsheets, blogs, videos and more…

The European Commission website also has a comprehensive overview of EUDAMED available here.

Disclaimer: This summary is offered without warranty of any kind, and any affiliate within the Johnson & Johnson family of companies accept(s) no responsibility or liability for any loss or damage arising from the use of or reliance upon this information.

Read Next

medical professional with clear plastic protective googles examines something under a microscope

EU MDR Improving Traceability & Transparency

EU MDR will continue to ensure the quality, safety, reliability and traceability of medical devices sold in Member States and countries that leverage the CE Mark, by providing access to more transparent information.

Medical professional with a stethescope draped around her neck looks at a digital tablet while a male patient looks on

EU MDR & HCPs – What’s Changing?

How do HCPs start to understand and prepare for such a major change? Here’s a summary of five new EU MDR responsibilities to begin with…

A smiling medical professional with a stethescope draped around her neck and a clipboard in hand explains something to a female patient

EU MDR Patient Impact

EU MDR is the largest change of its kind in recent history, impacting more than 500,000 medical devices in 90 countries. The new requirements will have a direct impact on the experience of patients. Find out three things that patients should know about EU MDR.