As from 17 January 2022, the new revised Commission’s sectorial webpages on Medical Devices are available from the Directorate-General for Health and Food Safety (DG SANTE)’s Public Health website.
Within the transformation and upgrade of the Public Health website, the sectorial webpages on medical devices have been aligned with the Commission’s corporate design. This includes the possibility to profit from new platform tools – such as easier searches for documents – and to use common content templates – like for news, events and publications.
The contents on the pages on medical devices remain structured in 6 main sections:
- Medical Devices – Sector: https://ec.europa.eu/health/medical-devices-sector_en (Overview, Current Directives, New Regulations)
- Medical Devices – New Regulations: https://ec.europa.eu/health/medical-devices-new-regulations_en (Overview, Getting ready, Guidance)
- Medical Devices – Topics of Interest: https://ec.europa.eu/health/medical-devices-topics-interest_en (Overview, Notified bodies, Unique Device Identifier – UDI, Reprocessing – and soon, also Harmonised standards)
- Medical Devices – Dialogue between interested parties: https://ec.europa.eu/health/medical-devices-dialogue-between-interested-parties_en (Overview – with the Medical Device Coordination Group – MDCG and its 13 Subgroups https://ec.europa.eu/health/medical-devices-dialogue-between-interested-parties/medical-device-coordination-group-working-groups_en and the Contacts for medical devices https://ec.europa.eu/health/medical-devices-sector/new-regulations/contacts_en –, International Cooperation)
- Medical Devices – Expert Panels: https://ec.europa.eu/health/medical-devices-expert-panels_en (Overview, Work, Experts, How to Apply)
- Medical Devices – Eudamed: https://ec.europa.eu/health/medical-devices-eudamed_en (Overview, Actors registration, UDI/Devices registration, Notified bodies and Certificates – and soon, also the remaining modules)
The links in the previous website have been adequately redirected, however it is very convenient to update your favourite bookmarks!
In all pages there are also direct links to the “Latest updates” https://ec.europa.eu/health/medical-devices-sector/latest-updates_en, “Highlights”, “Events” and “Documents” sections.
As usual, all the relevant information is continuously updated and available to the sectorial professionals, interested parties and the general public. It includes notably:
- the legal texts as published in the Official Journal of the European Union and in EUR-Lex,
- the lists of harmonised standards as in the Harmonised Standards website,
- the lists of notified bodies as published in the NANDO information system,
- the activities of the Medical Device Coordination Group (MDCG) as from the “Register of Commission Expert Groups and Other Similar Entities” https://ec.europa.eu/transparency/expert-groups-register/screen/expert-groups/consult?do=groupDetail.groupDetail&groupID=3565,
- the latest news on the “Implementation rolling plan for Regulations (EU) 2017/745 and (EU) 2017/746”,
- the “Ongoing guidance development and deliverables of MDCG Subgroups”,
- the “Overview of notified bodies at each stage of the designation process”, etc.