The EU Council's Working Party on Pharmaceuticals and Medical Devices is scheduled to meet on 27 and 28 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 both days at the Council's Lex Building, will focus on key technical aspects of the proposed simplification.
Agenda item 1 covers detailed discussions on Clusters 3 and 4, Block 3, addressing notified bodies and conformity assessment, including sampling and certificate validity, based on document 11546/26. Block 4 will examine post-market surveillance (PMS), periodic safety update reports (PSUR), vigilance reporting, reporting of actively exploited vulnerabilities and severe cybersecurity incidents, analysis of vigilance reports, and trend reporting, as outlined in document 11549/26. Additionally, Cluster 5 (excluding Article 4, Article 51, and market surveillance) will be discussed, with document 11961/26 to be distributed. Agenda item 2 is reserved for any other business.
The meeting follows the European Commission's ongoing efforts to streamline the regulatory framework for medical devices, which has faced criticism for complexity and delays in certification. The Working Party's exchange of views is a preparatory step before the proposal is discussed at higher Council levels and with the European Parliament. No prior coverage of this specific meeting exists in recent records.
Stakeholders impacted include medical device manufacturers, who face compliance costs under current rules; notified bodies, which are responsible for conformity assessments; healthcare providers relying on timely access to devices; and patients, who benefit from safer and more innovative products. The simplification aims to reduce administrative burdens while maintaining safety standards, balancing industry competitiveness with public health protection.
Following the Working Party's discussions, the proposal will likely proceed to the Permanent Representatives Committee (COREPER) and then to the Council for formal adoption, with the European Parliament expected to weigh in under the ordinary legislative procedure.