Newsletter No 25 May 2021
Subject: MDR open topics – EUDAMED and Transparency
Backgroud once again
The Medical Devices Regulation (EU) 2017/745 of the European Parliament and of the Council was adopted on 5 April 2017. This new regulatory framework sets high standards of quality and safety for medical devices and aims at ensuring the smooth functioning of the internal market. In response to the COVID-19 pandemic, and with patient health and safety as a guiding principle, following the proposal of the Commission, the European Parliament and the Council on 23 April 2020 adopted Regulation (EU) 2020/561, which defers by one year the date of application of Regulation (EU) 2017/745 to 26 May 2021. At the same time, Regulation (EU) 2020/561 also defers the application of the provision repealing Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices.
New DoA of MDR is 26 May 2021.
Transparency is a key objective of the Medical Devices Regulation (MDR) aiming at providing a large access to relevant information to the public and strengthening public and patient confidence in the safety of medical devices placed on the EU market.
The transparency requirements under the MDR can be divided in different categories:
- Information on medical devices made accessible to the public in Eudamed.
- Information which is pro-actively made publicly available outside Eudamed by the Commission, the national competent authorities, the industry or the notified bodies.
Most of the requirements on Transparency and public access to information are linked to the Eudamed, which is planned to become fully functional by May 2022.
The public access to the information registered in the different modules of Eudamed is extensive. It will provide citizens with the possibility to search for information related to devices, their manufacturers and certificates of conformity, the notify bodies which have delivered them and some information related to the clinical investigations and the incident reports associated with the devices.
For each module of Eudamed, two interfaces are being developed: one accessible only by the actors (Member States, operators and notified bodies) and one for the public. It means that each time a new module is released (e.g. actors, devices or certificates), the two interfaces are simultaneously made available.
The MDR transparency requirements listed below are presented separately depending whether they will be available in or outside the Eudamed database. The list below focusses on key information to be made available and is not exhaustive:
- List of key information which will be accessible to the public in Eudamed
The information accessible to the public in Eudamed relates to the:
- 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.
- List of key information which shall be publicly available outside Eudamed
This information is related to the general transparency requirement in the MDR and will be made publicly available outside Eudamed:
- 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.
The above lists indicates the information which will be made available to the public respectively in Eudamed and outside Eudamed, respectively from the entry into application of the MDR (May 2021) and the release of Eudamed (planned for May 2022).
However, it does not necessarily mean that the information made available in the future will be strictly limited to the one listed above. Transparency in the context of the MDR can be considered as a step by step process that may include other areas in the future.
More information, could progressively be made available in Eudamed based on experience gained on the impact of transparency in particular on the various reporting activities and the way this information is beneficial to the public.
This newsletter was part of our campaign to increase the sensitivity and the awareness of all our business partners, to bring more clarity around the MDR journey and challenges and opportunities around the MDR Art.22 “Systems and Procedure Packs”.
STS Medical Group will be publishing this newsletter in a revised format, moving from a monthly to a quarterly publication beginning in September. Our intent is to continue to raise awareness and offer a position paper for discussion and interpretation on MDR issues. We will offer a new section on publishing the most interesting questions with answers.
For any questions or comments, please write us MDR2020@stsmedicalgroup.com
The next MDR Newsletter will be issued in September. Thanks for continuing to follow STS.
CEO STS Medical Group
Katarzyna Zofia Chrusciel
Corporate Technical Director
Quality Management and Regulatory Affairs