Glossary · EU medical devices: MDR
Targeted revision of the MDR and IVDR (proposal)
Also known as: MDR and IVDR simplification proposal, MDR/IVDR targeted revision
The targeted revision of the MDR and IVDR is a legislative proposal the European Commission made in December 2025 to simplify the EU Medical Device Regulation (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 and to make them more proportionate and predictable. As of September 2026 it is in the legislative procedure and not applicable law.
- EU
- MDR
- IVDR
In one sentence
The Commission’s December 2025 proposal to simplify the MDR and IVDR. As of September 2026 it is still in the legislative procedure, not applicable law.
Example
A regulatory affairs team notes the proposal in its regulatory watch list and plans its notified body submissions under the current MDR, revisiting the plan only once an amending regulation is published in the Official Journal.
How it applies
- Status: A proposal, not law. European Parliament and Council must agree on a text, and it must be published in the Official Journal before anything changes. Check the current status before relying on it.
- Scope: According to the proposal, it addresses areas such as certification, notified body procedures and reporting burdens. Details may change in the negotiations.
- Current obligations: Until an amending act applies, manufacturers work under the MDR and IVDR as they stand, including the adopted transition periods.
- Context: The proposal shares its aim with the EU’s wider simplification agenda, including the omnibus packages, but it is a separate legislative file.
- Technical documentation: Don’t cite proposed provisions as requirements in technical documentation, procedures or training. If you mention the proposal, label it as such and date the statement.
Proposal vs. adopted amendment
Regulations (EU) 2023/607 and 2024/1860 are adopted amendments: they changed the transition periods and added Article 10a, and they apply. The targeted revision is a proposal whose content can still change or fail. Documents should keep the two apart, the same way the AI regulation glossary separates the adopted Digital Omnibus on AI from earlier drafts.