EU IVDR Simplification Proposal COM(2025) 1023 and Implementing Regulation 2026/977

1. Key takeaways

Two in-flight changes will shape how the IVDR is applied in practice. First, COM(2025) 1023 final (2025-12-16, procedure number 2025/0404(COD)) is the Commission’s simplification amendment proposal; it is not yet adopted and only becomes binding law after passage by the European Parliament and the Council under the ordinary legislative procedure. Second, Implementing Regulation (EU) 2026/977 has been adopted and published and applies from 2027-02-25 (with the annual reporting obligation from 2028-01-01); it harmonises the quotation, time limit and process requirements that apply to notified bodies carrying out conformity assessments under both the MDR and the IVDR. The practical consequence for manufacturers is asymmetric: the proposal should be tracked but never relied upon, while the implementing regulation must already be built into contracts, quotation reviews and project scheduling models.

2. Legal basis

3. Expert insights

Insight 1: A proposal is not law, and citations must state the status.

COM(2025) 1023 has been submitted to the European Parliament and the Council and only becomes binding Union law once adopted under the ordinary legislative procedure. The Commission has simultaneously published unofficial working documents integrating the proposed amendments into consolidated MDR and IVDR texts, expressly declaring that these documents have no legal effect. As of the verification date of this article, this series treats no statement of the proposal as being in force as established; the anticipated adoption timing mentioned in third-party legal sources (Q2 2027) is a forecast and carries no commitment. Any internal policy document that cites the proposal must label it as pending, otherwise the company’s own compliance basis becomes unverifiable. Once adopted, the consolidated text will need a controlled transition into internal procedures, which is itself a change-management project worth preparing for.

Insight 2: The direction of the proposal is burden reduction, digitalisation and predictability.

According to the Commission’s official overview, the proposal covers eight areas of modification: enhancing simplification and proportionality, reducing administrative burden, innovation, cost efficiency of certification, harmonisation, digitalisation, international cooperation and alignment with other legislation. The Commission states its objective as making the rules simpler, faster and more effective while maintaining a high level of patient safety. For manufacturers, the practical reading is that documentation proportionality may improve in future, but no planning decision should depend on that yet, since the final adopted text may differ from the proposal, and co-decision can move the substance in either direction during the negotiations.

Insight 3: The key numbers of Regulation (EU) 2026/977 are already fixed.

Applicable from 2027-02-25: application review and contracting 30 days; QMS audit 120 days; technical documentation (product) review 90 days; decision, issuing of certificates and entry in EUDAMED 20 days. For changes: review of planned changes 30 days, additional review 90 days, issuing of supplementary certificates 20 days, and re-certification review 90 days. On fees: quotations must itemise the QMS audit and technical documentation review fees, routine surveillance and unannounced audit fees, an estimate of potential additional costs and an estimated timeline; where actual fees exceed the quotation estimate by more than 10%, the body must justify this in writing in advance. From 2028, bodies must publish by 30 April each year a report on median fees and on-time completion rates for the previous year. These figures give manufacturers, for the first time, a common quantitative basis for comparing bodies across the market, and procurement teams should prepare to use them.

Insight 4: The time limits are obligations on notified bodies, not deadlines for manufacturers.

Regulation (EU) 2026/977 creates enforceable duties for notified bodies; the expiry of a time limit does not by itself constitute sufficient grounds for a body to refuse to issue a certificate. The regulation also sets the permitted number of interruptions of the procedure in Article 3 (one for complete application review, four for QMS audits, four for product verification, five in total for planned change stages, three for re-certification review, and one for certificate information verification), and extensions of interruptions require justification and written agreement. When building project schedules, manufacturers should model these interruption allowances rather than assuming continuous calendar-time processing, because a single interruption can extend an overall timeline by weeks even when every individual deadline is respected.

4. Practical recommendations

1. Add COM(2025) 1023 to the regulatory tracking list, but do not treat it as a compliance basis until it is adopted.
2. From 2027-02-25, renew or supplement notified body contracts against the benchmarks of Regulation (EU) 2026/977, covering itemised quotations, time limits, interruptions and fee-increase notifications.
3. Build interruption counts and extension rules into the project scheduling model instead of estimating on calendar days alone.
4. Use the annual median fee and on-time completion rate reports that bodies must publish from 2028 as quantitative criteria when selecting a notified body.
5. Use the Commission’s unofficial consolidated documents to understand direction, but always cite the original COM(2025) 1023 text and EUR-Lex in formal documents.

5. Verification checklist

• □ Confirmed that COM(2025) 1023 is not yet adopted and is not cited as current law
• □ The proposal date of 2025-12-16 and procedure number 2025/0404(COD) are recorded
• □ The application date 2027-02-25 and the annual reporting start 2028-01-01 of Regulation (EU) 2026/977 are confirmed
• □ Notified body contracts are updated with itemised quotations, time limits and the 10% fee-increase notification clause
• □ The project scheduling model includes interruption counts and extension rules
• □ The Commission’s unofficial consolidated documents are labelled as having no legal effect

Legal information verified as of 29 October 2026.

GRZAN supports IVD manufacturers in navigating the changing EU regulatory landscape: tracking the COM(2025) 1023 simplification proposal, re-aligning notified body contracts and project schedules with the time limits of Regulation (EU) 2026/977, and benchmarking bodies using published fee and completion data. For support with regulatory tracking and certification planning, contact info@grzanglobal.com.