COM(2025) 1023: The MDR and IVDR Simplification Proposal Explained

1. Key takeaways

On 16 December 2025 the European Commission submitted COM(2025) 1023 final (procedure number 2025/0404 (COD)), proposing a targeted simplification of the MDR and the IVDR. The proposal has not yet been adopted by the European Parliament and the Council under the ordinary legislative procedure and is not binding. Three accompanying instruments that are already in force or in the pipeline run in parallel: Implementing Regulation (EU) 2026/977 (uniform requirements for conformity assessment and notified bodies), Delegated Regulation (EU) 2026/1451 (2026-03-20, list of clinical investigation exemptions) and Delegated Regulation (EU) 2026/1359 (2026-03-20, list of exemptions from device-by-device technical documentation assessment for Class IIb implantables).

For readers who track EU medical device regulation professionally, the key skill here is separating the layers by their legal force: the two 2026 delegated and implementing regulations bind now, the transitional rules of Regulation (EU) 2024/1860 bind now, and the proposal binds nothing until the co-legislators adopt it. Dossiers, budgets and classification decisions should follow that order of authority.

2. Legal basis

The documents referenced below are the proposal, the three 2026 instruments that accompany it, and the transitional regulation still governing legacy certificates.

3. Expert insights

Insight 1: The official figures of the proposal can be cited, but they must not be treated as current law.

The explanatory statement of COM(2025) 1023 final (2025-12-16) states that the European medical technology market was worth about EUR 170 billion in 2024, that Europe counts more than 38,000 medical technology companies, of which small and medium-sized enterprises make up about 90%, that the industry employs more than 930,000 people, and that 51 notified bodies are designated under the MDR and 19 under the IVDR. These figures come from an official document and can be cited as such. The proposal itself, however, acquires binding force only after adoption under the ordinary legislative procedure, and the official Commission page states this explicitly.

Insight 2: The problems the proposal seeks to solve are predictability and proportionality.

The explanatory statement identifies two problems: conformity assessment lacks predictable time limits and practice differs between Member States; and some requirements are disproportionate to the actual risk of the device, generating unnecessary costs and burdens that may push manufacturers, especially small and medium-sized enterprises, to stop supplying devices or to delay placing them on the market. This language is useful for gauging the direction of future amendments, but it cannot be used to infer concrete deadlines before the legislative process concludes.

Insight 3: The three 2026 instruments are already effective and take priority over the proposal.

Implementing Regulation (EU) 2026/977 (2026) establishes uniform requirements for conformity assessment and notified bodies (Annex VII); Delegated Regulation (EU) 2026/1451 (2026-03-20) amends the list of implantable devices and Class III devices exempt from clinical investigation duties; Delegated Regulation (EU) 2026/1359 (2026-03-20) amends the list of Class IIb implantable devices exempt from device-by-device technical documentation assessment. These three instruments already affect project scheduling and technical documentation preparation, and their priority is higher than that of the proposal, which is still within the legislative procedure. Since these instruments are published acts, their exemptions can be relied upon immediately where a product appears on the relevant list, and that reliance should be recorded in the technical documentation with a reference to the regulation and the list entry.

Insight 4: Corporate preparation has three layers and does not stop because of the proposal.

Layer one, now: apply the current text of the MDR, with the focus on the mandatory use of the first four EUDAMED modules (2026-05-28) and the self-check of legacy certificate eligibility. Layer two, near term: verify the specific impact of the three 2026 instruments on each project. Layer three, watch: track the legislative progress of COM(2025) 1023, but do not adjust completed technical documentation on the basis of the proposal (a practical estimate).

4. Practical recommendations

The measures below keep the company aligned with binding law while staying informed about the proposal.

1. Build a legislative process board distinguishing four categories: regulations in force, implementing regulations, delegated regulations and pending proposals, each annotated with its impact on the project.
2. Apply the current MDR text now, confirming the mandatory EUDAMED first four modules (from 2026-05-28) and legacy certificate eligibility (the three thresholds expired on 2024-05-26 / 2024-09-26).
3. Verify product by product the applicability of (EU) 2026/977, (EU) 2026/1451 and (EU) 2026/1359.
4. Track the content of the proposal, but do not downgrade classifications or cut clinical evidence in advance on its basis.
5. Review notified body numbers and capacity: the 51 figure from the proposal text is citable, and the real-time status is to be checked against NANDO.

5. Verification checklist

Use the checklist below at quarterly compliance reviews while the legislative process is ongoing.

• □ A four-category legislative process board is in place (regulations, implementing regulations, delegated regulations, pending proposals)
• □ Mandatory use date of the first four EUDAMED modules (2026-05-28) is embedded in the process
• □ Self-check of legacy certificate eligibility against the three thresholds is complete
• □ Applicability of (EU) 2026/977, (EU) 2026/1451 and (EU) 2026/1359 has been verified
• □ COM(2025) 1023 (2025-12-16, 2025/0404 (COD)) has been confirmed as a pending proposal
• □ Notified body number citations carry their source (51, from the text of COM(2025) 1023) and are checked against NANDO

Regulatory information verified as of 29 October 2026.

GRZAN regulatory support. GRZAN assists medical device manufacturers with post-market compliance in the European Union market under Regulation (EU) 2017/745, covering vigilance reporting, field safety corrective action (FSCA) recalls, and responses to competent authority inspections, as well as monitoring of legislative developments affecting the MDR and IVDR. If you need support with your EU MDR post-market obligations, contact info@grzanglobal.com.