Europe, 16 December 2025 — The European Commission has officially adopted a proposal to amend Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) in the EU Medical Device Regulation aims to simplify the regulatory rules, reduce administrative burden, and prevent shortages of critical medical devices. The proposal acknowledges that the current regulatory framework has created structural issues, leading to high compliance costs and the risk of device discontinuations. This new act is designed to streamline certification and support innovation without compromising safety.
EU MEDICAL DEVICE REGULATION: KEY DATES AND TIMELINE FOR MANUFACTURERS
The publication of this proposal initiates the legislative process. Once adopted by the European Parliament and Council and published in the Official Journal of the EU (OJEU), it triggers the following specific timelines based on Article 5 of the proposal:
Entry into Force (20 days after publication): The Regulation formally enters into force.
Immediate Application (Upon Entry into Force):
- Legacy Orphan Devices: The “grandfathering” clause applies immediately. Orphan devices lawfully marketed under the old Directives (MDD/AIMDD/IVDD) can remain on the market without a full MDR/IVDR certificate if they meet specific orphan criteria and do not present unacceptable risks.
- Expert Panels: New rules regarding the support and role of EMA and expert panels apply immediately.
6 Months after Entry into Force (Date of Application):
- This is the main application date for most simplification measures.
- Certificate Validity: The removal of the 5-year maximum validity for certificates applies from this date. Certificates will no longer expire but will be subject to periodic surveillance.
- Well-Established Technologies: Reduced data requirements for “Well-Established Technologies” (WET) become applicable.
12 Months after Entry into Force:
- Changes related to the designation, monitoring, and coordination of Notified Bodies apply.
Years after Entry into Force:
- New provisions regarding the reprocessing of single-use devices become applicable.
KEY SIMPLIFICATION MEASURES IN THE EU MEDICAL DEVICE PROPOSAL FOR MANUFACTURERS
The EU Medical Device proposal introduces several critical changes to reduce “red tape” and streamline market access :
- Abolition of Certificate Expiry: The requirement for CE certificates to expire every 5 years is removed. Certificates will remain valid indefinitely, subject to continued surveillance, eliminating the costly re-certification cycle.
- Breakthrough & Orphan Pathways: New definitions and priority pathways are introduced for “Breakthrough Devices” (high clinical impact) and “Orphan Devices” (treating <12,000 individuals/year). These devices will benefit from priority access to Notified Bodies and expert panel advice.
- Reduced Burden for ‘Well-Established Technologies’: Devices defined as “Well-Established Technologies” (WET) those with a simple, stable design and known safety profile will face reduced clinical data requirements.
- Digitalization:
e-IFU: Manufacturers of near-patient tests and other specific categories will be allowed to provide electronic Instructions for Use (eIFU).
Digital Documentation: Technical documentation and Declarations of Conformity can now be created and submitted in digital formats. - SME Support: Notified Bodies will be required to offer fee reductions of at least 50% for micro-enterprises and 25% for small enterprises.