What do the EU’s new notified-body timelines mean for your launch plan?
A cardiovascular device manufacturer in the U.S. preparing for European Market Authorization needs an assessment estimate it can use. Production capacity, distributor commitments and financing may all depend on when the product can reach the market. A defined review period appears to offer a firmer basis for those decisions.
The difficulty is deciding what that period actually covers. A 90-day product-verification limit is useful information, but it does not tell the company when to promise its first commercial shipment. The answer also depends on when assessment starts, which other activities must finish, and what happens when the notified body needs information the manufacturer cannot yet provide.
The EU’s adopted notified-body timeline rules make these dependencies more explicit. Their value is a clearer basis for planning and agreeing assessment work. To use them well, the manufacturer needs to connect each regulatory milestone to the work that makes it achievable.
Establish whether the new clocks apply
Commission Implementing Regulation (EU) 2026/977 was adopted on 4 May 2026 and published the following day. It is an adopted measure, separate from the wider proposed MDR reforms. Its general application date is 25 February 2027. [1,2]
The transition is important for a company arranging assessment now: Articles 1–3, covering quotations, timelines and interruptions, do not apply to procedures for which the manufacturer and notified body signed a written agreement before 25 February 2027. A review continuing beyond that date does not automatically acquire the new clocks. [1]
That makes the agreement for the assessment activity a practical planning input. Before incorporating the new limits into a launch forecast, the company needs to establish which procedure and agreement its forecast concerns. The discussion below focuses on initial assessment under the MDR; changes and recertification have their own provisions.
Understand what each period measures
Article 2 establishes maximum periods for defined activities. It also requires the notified body’s procedures to ensure agreement on the shortest possible timeline, taking account of the devices and the assessment work. The maxima are not prescribed standard durations for every project. [1]
| Activity | Maximum period | Start and endpoint |
|---|---|---|
| Application review and contract | 30 days | Receipt of the complete application to signature of the contract |
| Quality management system auditing | 120 days | First activity in the audit programme to completion of its final review |
| Product verification | 90 days | Start of technical-documentation assessment for each device or representative device to completion of its final review |
| Decision and certification | 20 days | Day after the last relevant final review to issuance of the certificates and their entry in Eudamed |
These are the Article 2(2) periods, subject to the interruption provisions discussed below. They cannot simply be added together. Under Annex IX assessment, the QMS and product-verification activities must run in parallel, provided the required technical-documentation assessment input is taken into account when developing the audit programme. Unless otherwise agreed, those activities start the day after contract signature. [1]
For the manufacturer, this creates several meaningful distinctions. An initial enquiry is not a complete application. Starting an audit programme is not the same as arriving for an on-site audit. Completing product verification is not the final certification step.
Those distinctions should be visible in the commercial forecast. If a plan starts its 90-day countdown when the team asks for a quotation, it starts from the wrong event. If it ends at product review without accounting for the other relevant final review and the certification phase, it ends too soon.
A paused assessment still consumes project time
Article 3 allows interruptions when the manufacturer must address non-compliances or duly justified questions and requests necessary for assessment. The regulation limits the number of interruptions by phase, with additional arrangements for matters such as rolling documentation review and extra audited sites. It does not turn those limits into a fixed allowance for total elapsed waiting time. [1]
The notified body agrees the interruption’s duration with the manufacturer and informs it in writing. The clock stops when the manufacturer is informed of the requests and, unless otherwise agreed, resumes the day after the requested information is received. Required opinions from bodies such as the EMA or an expert panel trigger separate interruptions outside those phase counts. [1]
The distinction matters because answering a question can mean very different kinds of work. Clarifying an existing rationale may take little preparation. Producing evidence that does not yet exist can involve a protocol, samples, testing and analysis before the manufacturer has an adequate response.
The legal clock can be interrupted during that work. The company’s cash expenditure, supplier commitments and commercial expectations continue. An agreed interruption makes the assessment status clearer; it does not remove the underlying development dependency.
Follow the evidence dependency into the launch decision
Consider a hypothetical manufacturer seeking assessment of a sterile vascular catheter family. It has planned product verification and QMS auditing under Annex IX and wants to commit to a distributor launch window.
During the technical-documentation assessment, a justified question asks whether the tested configuration adequately represents the most demanding intended use within the claimed family. In this example, the team concludes that it needs additional bench work to support its answer. An interruption is agreed while that work is completed.
The commercial consequence depends on more than the number of assessment days remaining. The manufacturer must obtain appropriate samples, perform the work and evaluate whether the results support the proposed scope. If the evidence instead supports a narrower product family, that may change what the company is ready to offer its distributor.
A forecast based only on the 90-day period misses this decision. The relevant uncertainty is whether the evidence can support the product scope on which the launch commitment depends.
Zaliance’s recommendation is to make that dependency explicit before treating assessment duration as a dependable shipment date. This does not mean predicting every reviewer question. It means identifying the unresolved evidence assumptions that could require substantial work, rather than allowing the assessment estimate to conceal them.
Use the rules to improve the agreement and the forecast
The regulation also connects quotations to information about the device, assessment procedure, manufacturing sites and relevant supplier activities. Quotations must include estimated timelines and costs, including possible additional costs. This gives the manufacturer a more defined basis for discussing the work it is buying. [1]
Zaliance recommends using that discussion to connect the scope, agreed start arrangements and major evidence dependencies in one project forecast. QMS and product work should reflect the applicable parallel arrangement; work that depends on a technical finding should remain linked to that finding. Commercial preparation can then be sequenced according to which assumptions remain open and which commitments would be expensive to reverse.
A deadline also does not substitute for a conformity decision. Article 2(4) requires assessment to continue until a decision to issue or refuse a certificate; expiry of a maximum period is not, by itself, a sufficient reason for refusal. It does not provide automatic certification when time runs out. [1]
The useful planning question is therefore how much of the proposed launch date rests on defined assessment work, and how much rests on evidence or decisions still to be completed. The new rules help make the assessment portion more concrete. A credible European launch plan shows how the rest of the work will get the company to that point.
References
[1] Commission Implementing Regulation (EU) 2026/977 of 4 May 2026. Official Journal, 5 May 2026. Article 1, printed/PDF p. 4; Article 2(1)–(2), p. 5; Article 2(4) and Article 3, pp. 6–7; Articles 8–9, p. 10. https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj/eng/pdf
[2] European Parliament Legislative Observatory. Procedure 2025/0404(COD), simplification of rules on medical devices and in vitro diagnostic medical devices. Proposal procedure, checked 20 October 2026 UTC; separate from adopted Regulation 2026/977. https://oeil.europarl.europa.eu/oeil/en/procedure-file?reference=2025/0404(COD)