The EU Council's Working Party on Pharmaceuticals and Medical Devices is scheduled to meet on 15 and 16 July 2026 in Brussels to exchange views on a regulation aimed at simplifying rules for medical and in vitro diagnostic devices. The meeting, set to begin at 10:00 each day in the Council's Lex Building, will cover four thematic blocks based on documents distributed to delegates.
Agenda item 1, the core of the session, addresses classification of devices, notified bodies, and conformity assessment (excluding sampling and certificate validity) under document 11243/26. A second block, document 11244/26, focuses on clinical evidence, evaluation, investigations, non-clinical data, and post-market clinical follow-up. Depending on progress, delegates may also discuss notified bodies and conformity assessment including sampling and certificate validity (document 11546/26), as well as post-market surveillance, PSURs, vigilance reporting, and cybersecurity incident reporting (document 11549/26). The meeting will conclude with any other business.
No prior coverage of this file exists in recent months, making this the first documented step in the Council's examination of the simplification regulation. The working party's exchange of views will inform subsequent negotiations among member states and with the European Parliament. Stakeholders, including medical device manufacturers, notified bodies, healthcare providers, and patient groups, will be closely watching the outcome, as changes to classification and conformity assessment could affect market access timelines and compliance costs. The regulation aims to streamline the current framework, potentially reducing administrative burdens while maintaining patient safety standards. Institutional follow-up is expected to include a mandate for the Council to begin trilogue negotiations once the Parliament adopts its position.