Skip to main content
RAPS Euro Convergence 2026 Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Presentation Icons
Learning Level: Advanced
Learning Level: Advanced
Learning Level: Expert
Learning Level: Expert
Learning Level: Foundational
Learning Level: Foundational
Learning Level: Intermediate
Learning Level: Intermediate
RAPS Focus
RAPS Focus
Networking Opportunity
Networking Opportunity
Ticketed Event
Ticketed Event
Student Focus
Student Focus
ViewAttendees 9

Medical Devices

Environmental Convergence: Horizontal EU Requirements Reshaping Medical Device and IVD Regulation

Thursday, May 7, 2026
14:30 - 15:30 WEST
Location: Auditorium 1
Learning Level: Advanced
Description: Medical device manufacturers face an increasingly complex web of horizontal EU environmental regulations that intersect with MDR and IVDR requirements with respect to environmental requirements, such as the Batteries Regulation, Ecodesign Regulation, RoHS, WEEE and REACH.

The European Commission's targeted revision of MDR and IVDR, as well as the revision of the New Legislative Framework (Regulation 765/2008) aims to better align the regulatory framework with other relevant legislation, creating more convergence between environmental and medical device law and potentially providing environmental performance criteria for medical devices and IVDs as recently adopted under the Construction Products Regulation. This session will examine current environmental obligations arising from a variety of EU regulations, analysing how these intersect with device-specific requirements.

The session will provide forward-looking analysis of how environmental considerations may be integrated into the revised MDR and IVDR, expected by the end 2025, the revision of the underlying basic regulations for CE marking, discuss emerging trends in sustainable device design and circular economy principles.

Learning Objectives:

  • Upon completion, participants can analyse current horizontal EU environmental requirements applicable to medical devices and IVDs and their intersection with device-specific regulations.
  • Upon completion, participants can evaluate the potential impact of the targeted MDR/IVDR revision on environmental compliance obligations and regulatory alignment.
  • Upon completion, participants can develop forward-looking environmental compliance strategies that anticipate future EU sustainability requirements for medical devices.