EU Preliminary Draft 2027 AUWP Includes Standardisation Request for Medical Devices and IVDs
The preliminary draft 2027 Annual Union Work Programme for European standardisation includes a dedicated action on medical devices and in vitro diagnostic medical devices.
The action is linked to Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
Planned Standardisation Request
According to the draft, the European Commission is planning a standardisation request for the development and revision of harmonised European standards for medical devices and IVDs.
The action is intended to complement and update the deliverables requested under standardisation request C(2021)2406 — M/575, in response to new technical and regulatory needs.
The document also states that the work should take account of ongoing CEN and CENELEC activities and avoid duplication.
Purpose of the Action
The objective of the action is to support the effective implementation and enforcement of the EU regulatory framework for medical devices and IVDs.
By providing presumption of conformity with the requirements they cover, harmonised standards are expected to facilitate compliance and efficient conformity assessment.
Expected Benefits
The draft highlights several expected benefits from the standardisation action.
These include strengthening patient and user protection, supporting competent authorities, promoting innovation and competitiveness, and contributing to the proper functioning of the internal market.
Wider Context of the 2027 AUWP
The medical devices and IVD action appears under the priority area “Making the most of the Single Market.”
The broader preliminary draft 2027 AUWP also includes actions across several other areas, including high-risk AI systems, advanced materials, industrial emissions, nanoplastics, soil health, e-invoicing, digital public procurement and PFAS-free alternatives for personal protective equipment.
Link With the 2026 AUWP Implementation Status
The document also includes a state of implementation table for the 2026 AUWP as of 31 May 2026.
Several actions were still under preparation, scoping, consultation or awaiting legislation, including artificial intelligence, cybersecurity requirements for products with digital elements, quality data for AI and innovation, and microplastics.
This context shows that the 2027 preliminary draft sits within a broader standardisation work programme covering both new priorities and ongoing implementation activities.
Impact on Medical Device and IVD Manufacturers
For medical device and IVD manufacturers, the planned standardisation request is relevant because harmonised European standards play an important role in demonstrating conformity under the MDR and IVDR.
Manufacturers should pay particular attention to:
future development and revision of harmonised standards;
potential updates to deliverables under M/575;
alignment with MDR and IVDR requirements;
ongoing CEN and CENELEC work;
new technical and regulatory needs;
implications for conformity assessment;
presumption of conformity;
documentation and compliance planning;
impact on innovation, competitiveness and market access.
For manufacturers placing products on the EU market, the key message is that standardisation work remains a strategic part of MDR and IVDR implementation, with potential implications for technical documentation, conformity assessment and regulatory planning.
