The European Commission services recently issued a Fact sheet on MDR requirements for Transparency and Public Information.
The document first emphasizes the importance of transparency under the MDR and its close link with EUDAMED in order to provide ”a large access to relevant information to the public and strengthen public and patient confidence in the safety of medical devices placed on the EU market.”
It is noted that each EUDAMED module will be created by providing two interfaces, one accessible only by the actors, i.e. Member States, economic operators and notified bodies, and a second one for the public.
As under the MDR, there are two categories of transparency requirements (either via EUDAMED or by other means), the Commission services list the information below, which will be accessible to the public :
I. Information on medical devices made accessible to the public in Eudamed
- Registration of all manufacturers, their authorised representatives and importers, which are placing medical devices on the EU market
- Registration of devices, the core elements of the UDI database of part B of Annex VI, including the basic UDI and UDI-DI of devices
- Registration of certificates of conformity, their scope and validity period
- List of notified bodies designated under the MDR, their identification numbers and their conformity assessment activities through a link to NANDO database and the list of their subsidiaries
- Scientific opinions of the expert panels and the written justification of the notified body where it has not followed the scientific opinion of the expert panel
- Clinical investigation reports and their summary
- The summary of safety and clinical performance reports for implantable devices and class III devices
- Manufacturer incident reports (partial access) and the field safety notices for Vigilance activities
- Summary of the results of market surveillance activities on their national territory by each EU Member State
II. Information which is pro-actively made publicly available outside Eudamed by the Commission, the national competent authorities, the industry or the notified bodies
- National measures taken by competent authorities for the placing on the market of single use devices which are reprocessed
- Types and levels of fees levied by Member States for funding activities carried out by the competent authorities
- National measures governing the assessment, designation and notification of notified bodies
- List of standard fees from notified bodies
- Summary of each Member State report on its monitoring and on-site assessment activities regarding notified bodies
- Commission annual summary report of the peer review activities of authorities responsible for notified bodies
- Declaration of interests of top-level management of notified bodies
- Declaration of interests of each member of the MDCG, of its sub-groups except for stakeholder organisations, and of the advisors within the expert panels and expert laboratories
- Advice provided by the expert panels
- Names and affiliation of the members of the MDCG
Please note that the above list is not exhaustive, and other information could be added in future! Follow MDlaw to remain updated.
You can find the Fact sheet in our Library of Documents icon: EUDAMED and European Commission.