What’s new
Two manufacturers with comparable devices could, until now, get very different answers from notified bodies on cost and on time, and neither answer bound anyone. Commission Implementing Regulation (EU) 2026/977, adopted on 4 May 2026 and published in the Official Journal on 5 May 2026, sets common procedural rules for notified bodies working under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). It applies from 25 February 2027.
It does not change classification, conformity assessment routes or the technical requirements. It changes the process around them: what a quotation must contain, how long each phase may take, when the clock may stop, and what re-certification may ask for.
Quotations you can plan with
A notified body may issue a quotation only after it has a defined set of information from the manufacturer: the devices and their intended purpose, risk class, the sites and suppliers involved, and the conformity assessment procedure applied for. The quote must break down the estimated cost and give the estimated timeline. If the cost is going to rise more than 10% above the estimate, the notified body must tell the manufacturer in advance and say why.
This sits on top of an older rule. Since the MDR and IVDR applied, notified bodies have had to publish their standard fees (MDR Article 50, IVDR Article 46), and MDCG 2023-2 (January 2023) set out how those lists should be presented. A list of standard fees told you the price of an hour or an audit day; a quotation under the new rules has to tell you what your project is expected to cost.
Maximum timelines
The regulation sets ceilings, not targets. Counted in days:
| Phase | Maximum |
|---|---|
| Application review and contract signature | 30 |
| Quality management system audit | 120 |
| Product verification (technical documentation) | 90 |
| Decision and certificate issue | 20 |
| Planned change: review | 30 |
| Planned change: additional assessment | 90 |
| Planned change: supplement issue | 20 |
The clock can stop while the notified body waits for the manufacturer, but only a limited number of times per phase: once in application review, four times each in the audit and in product verification (two more per additional site audited on site), five times across a planned change, three across a re-certification review. Stops to wait for the EMA, a competent authority, an expert panel or an EU reference laboratory are counted separately.
In our experience, the interruption counts matter more than the day counts. A file that arrives incomplete will use its interruptions early, and a notified body has every reason to ask its questions in fewer, larger batches. The quality of the first submission decides how the rest of the timeline behaves.
Re-certification with a defined scope
For product certificates, re-certification works from a focused package of what changed since the last certificate, assessed within 90 days. Quality management system re-certification is also reviewed within 90 days. The decision and re-issue follow within 20 days; if the decision comes more than three months before expiry, the 20 days start three months before expiry.
Published performance
Each notified body must report every year, by 30 April, on how it performs against the timelines and how its quotations compare with actual costs.
When it applies to you
The date that matters is the date of your written agreement with the notified body, not the date you submit. The rules on quotations, timelines and interruptions do not apply where the written agreement was signed before 25 February 2027. The re-certification rules do not apply to certificates expiring before 25 November 2027.
What it means for your product
If you are a small manufacturer still choosing a notified body, the timing is worth thinking about: an agreement signed after 25 February 2027 falls under these rules, one signed before does not. That is not a reason to delay a submission that is ready, because the regulation caps the notified body’s time, not yours, and capacity is still the constraint. It is a reason to ask every notified body you approach how it will apply the new quotation content and timelines, and to compare the answers.
The other change is on your side of the table. With fixed ceilings and a limited number of stops, an incomplete technical file costs you more than it used to. We prepare the submission package and track the notified body’s questions through to the certificate: Notified Body and CE marking.
Related briefing: How to demonstrate equivalence under the MDR