A plan submitted on time can still leave implementation outstanding. An accepted plan can still leave a finding open. Your schedule needs to show those differences, especially when testing, supplier records or clinical evidence will take longer than writing the response.
This guide helps you establish the response obligation for an EU medical-device assessment. It separates manufacturer deadlines, review rounds and Notified Body assessment clocks so you can ask a precise question and plan against a documented answer.
Establish what the date actually requires
Start with the finding letter or report, the assessment agreement and the procedure or portal instructions that apply to your submission. Read them together. A portal field labelled “response due” does not, by itself, explain what the reviewer expects to receive.
Record the finding reference and assessment stage before interpreting the deadline. A technical-documentation question, a QMS audit nonconformity and a request during certificate issuance can require different work. Also record whether you are seeking an initial certificate or maintaining an existing one. Those situations have different consequences, even if the email subject lines look similar.
Your first clarification should establish the required deliverable. A corrective action plan describes the work you propose. Implementation evidence shows what you completed. Effectiveness evidence tests whether the action achieved its purpose. Formal closure is the Notified Body's recorded disposition of the finding, not a status you can create by uploading a file.
Then establish the clock-start event, whether the period uses calendar or working days, and the exact due date. If the portal uses a submission cut-off, confirm its time zone. Do not assume that the audit date, report date and receipt date are interchangeable.
Where documents conflict, send the conflicting references to your Notified Body and ask which requirement governs this finding. Keep the earlier date visible as an internal escalation point while you seek clarification. Choosing the later date without confirmation turns a documentation ambiguity into a scheduling risk.
Why published response periods are not your deadline
Published timing guidance is useful context, but it does not replace the terms applicable to your assessment.
Page 21 of the Team-NB Code of Conduct, version 5 separates several milestones. It gives up to 30 days for a manufacturer's first corrective action plan and up to 30 days for the Notified Body to review the submitted plan. It also lists up to three attempts and up to 90 days to submit an acceptable plan.
Those are different activities. You should not add them together to create an allowance, or treat 90 days as permission to defer your first response. The table does not define a clock-start event, distinguish calendar from working days or assign separate major and minor nonconformity periods.
The same table lists up to 365 days for correction on the technical documentation or device under review, and separately for corrective action affecting other documentation or devices. These entries are not a general permission to leave a major finding unresolved for a year. They do not establish a separate formal closure date, and they cannot justify postponing necessary safety action.
Team-NB is an association, and this document is its code of conduct rather than legislation. Establish whether your Notified Body has incorporated the relevant provisions into its process and how they interact with your letter, agreement and applicable law.
The adopted text of MDR Article 56(4) illustrates a different point. For an existing certificate, it refers to appropriate corrective action within an appropriate deadline set by the Notified Body and to proportionate certificate measures. It does not supply a universal 30, 60 or 90-day manufacturer response rule. Use the current EU text for a live legal decision rather than relying solely on that adopted-text reproduction.
Build a milestone register rather than one countdown
A useful register shows which dates you have confirmed, which you have only proposed and what evidence each milestone needs. Keep the source beside the date so another person can understand the obligation without reconstructing an email thread.
The following populated example is illustrative. The device, finding, dates and correspondence are invented to demonstrate the method. They are not a Notified Body policy or a completed customer case.
Suppose an initial-certification QMS audit identifies an inadequate supplier-control process. The report, received on 2 November 2026, asks for a corrective action plan by 16 November. Your investigation also identifies work involving supplier reassessment, a procedure change and a later effectiveness check.
| Milestone | Source and date status | Owner and dependency | Evidence or decision to record |
|---|---|---|---|
| First corrective action plan by 16 November | Report NC-04, dated 2 November, states this date | Quality lead needs the investigation and an agreed action sequence | Submitted plan revision and portal receipt |
| Correct affected supplier records by 30 November | Manufacturer proposal only | Supplier-quality owner needs missing evaluation records | Completed evaluations and approval records |
| Implement revised process by 7 December | Manufacturer proposal only | Process owner needs procedure approval and staff training | Approved procedure and training records |
| Review effectiveness on 18 January 2027 | Manufacturer proposal only | Quality lead needs enough relevant activity to test the change | Defined sample, results and conclusion |
| Formal finding closure | No date confirmed | Notified Body review depends on sufficient evidence | Written closure decision and any remaining conditions |
The first row carries a stated obligation. The next three carry proposals that need assessment and, where relevant, agreement. The last row prevents you from reporting the finding as closed simply because your own work has finished.
The example assumes that 16 November is an explicit date. If the report instead says “within 14 days”, add the confirmed starting event and counting convention before calculating it. Also retain the agreement version, assessment reference, submission channel and any written clarification alongside the register.
Your internal readiness dates should sit before external submission dates, with time for technical review and approvals. Label those internal dates clearly. A target that you set for your document owner is not a deadline imposed by the Notified Body.
When the work will not fit the response window
Explain the dependency before the deadline rather than waiting until you have missed it. The useful question is whether the Notified Body will agree to a specific sequence of deliverables, not whether it can give you “more time” in the abstract.
In the illustrative supplier example, suppose the supplier cannot provide a required record until 25 November. That does not automatically prevent you from submitting the plan on 16 November. It does mean the plan must distinguish available evidence from work still outstanding and explain how you will manage the issue in the meantime.
A timing request should identify the finding, the current obligation, the evidence you can provide now and the dependency preventing completion. State a proposed date for the missing work, explain the basis for that date and describe relevant interim controls. Ask the Notified Body to confirm both the revised timing and what it expects in the original response.
An illustrative clarification could read as follows.
For finding NC-04, the report dated 2 November requires our corrective action plan by 16 November. We intend to submit that plan by the stated date. Supplier evaluation evidence depends on records expected on 25 November, and we propose submitting the completed evaluations by 30 November. Please confirm whether this sequence is acceptable and whether you require additional implementation evidence with the first response. Our proposed process implementation and effectiveness dates remain separately identified in the plan.
This is a model for making the question precise, not wording that secures an extension. Describe actual interim controls in your own request rather than borrowing an assurance that does not fit your device or finding.
An extension request is not an agreed extension. Preserve the existing deadline until you have a documented change, and escalate unresolved timing through the appropriate quality and regulatory owners. Do not delay risk controls or applicable safety and reporting obligations while waiting for a response.
Count review rounds separately from response deadlines
A review round describes a process step. A deadline describes when something is due. Neither tells you, on its own, how much substantive work remains.
BSI's MDR documentation submission guidance provides a concrete example of this distinction. Its page 9 flowchart labels a completeness-check loop with a maximum of two rounds and the technical-documentation questions and responses with a maximum of three rounds. These labels describe BSI's illustrated process, not an MDR-wide entitlement. Confirm how the applicable procedure counts the initial submission, follow-up questions and any exceptions.
| Process unit | What you need to establish | What you should not infer |
|---|---|---|
| Completeness-check iteration | Whether the submission contains what the assessment needs to begin | Passing completeness establishes conformity |
| Technical-documentation question round | Which questions belong to the round and what counts as a complete response | Every Notified Body permits the same number of rounds |
| QMS corrective action plan attempt | Whether the proposed investigation and actions meet the request | Acceptance of a plan closes the finding |
| Legal assessment-clock interruption | Which provision applies and what stops and restarts the clock | One interruption equals one guaranteed response round |
If a reviewer calls your next submission the final round, resolve the process question before you submit. Ask which procedure sets the limit, what remains unresolved and what happens if the evidence still does not demonstrate conformity. Keep any dispute about interpretation separate from the work needed to answer the finding.
A response that points more clearly to existing evidence may resolve a referencing problem. It cannot substitute for a missing test or an unsupported clinical conclusion. Your deadline plan needs to expose that difference early enough for the responsible expert to act.
Check whether Regulation (EU) 2026/977 applies
Commission Implementing Regulation (EU) 2026/977 introduces assessment-timing provisions, but those provisions do not turn every findings letter into the same manufacturer deadline.
The published regulation in the official Spanish EU gazette gives 25 February 2027 as its general application date in Article 9. Article 8(1) excludes conformity assessment procedures covered by written agreements signed before that date from Articles 1 to 3. Other provisions have separate transitional rules, so that exclusion should not become a claim that the entire regulation never applies to an older agreement.
For response planning, use this agreement-date decision tool.
| Question | Example or decision | Planning implication |
|---|---|---|
| Which written agreement covers this procedure? | Identify the signed agreement and the procedure it covers | Do not substitute the audit date or invoice date |
| Was it signed before 25 February 2027? | Illustrative agreement signed on 12 January 2027 | Article 8(1) excludes that procedure from Articles 1 to 3 |
| Was it signed on or after 25 February 2027? | Illustrative agreement signed on 1 March 2027 | The before-date exclusion does not apply, but check the covered procedure and relevant provision |
| Does the request interrupt an applicable assessment clock? | Obtain the written interruption notice and agreed duration | Track it separately from your evidence-delivery milestones |
| What confirms restart or an agreed extension? | Retain the submission receipt and written agreement | Do not infer a clock change from your internal forecast |
For procedures to which Article 3 applies, it addresses interruptions of the assessment time limit. It requires the Notified Body to agree the interruption duration with the manufacturer and inform the manufacturer in writing. Under Article 3(2), the interruption starts when the Notified Body informs the manufacturer of its requests, and the clock resumes, unless otherwise agreed, on the day after it receives the requested information. Article 3(4) requires due justification and written agreement for an extension of those interruption periods.
These rules concern the assessment clock. They do not establish a universal number of manufacturer response rounds. Article 3 uses stage-specific interruption limits and includes additional provisions for particular circumstances, so a headline number without its scope can mislead your planning.
Article 2(4) also states that exhausting the specified time or interruption limits is not, by itself, sufficient grounds for refusal. That does not guarantee acceptance or certification. You still need evidence demonstrating conformity, and the assessment continues to a decision.
Keep the deadline open until the right event occurs
After submission, retain the exact package revision and evidence index together with the receipt. If the portal confirms only an upload, record an upload. Do not translate that automatically into acceptance of a complete response, acceptance of the plan or closure of the finding.
When the Notified Body replies, update the milestone it has actually addressed. A request for revised dates may leave the substance of the plan unresolved. Acceptance of the plan may leave implementation and effectiveness work outstanding. A new question may create another deadline without changing the earlier commitments.
The practical result is a short, defensible answer to “where do we stand?” You can identify the next obligation, the source that establishes it, the evidence dependency and the decision still needed. That is more useful than a countdown that turns green when someone presses submit.
Questions that come up before submission
Do major nonconformities always have a 30-day deadline?
Do not assume that. Confirm the applicable requirement for your finding and the deliverable due. The Team-NB table's first-plan period is not a universal major-nonconformity closure rule.
Can I submit the plan before all actions are complete?
Only if that meets the request governing your response. Separate completed work from proposed actions and outstanding evidence. Ask for clarification if the letter appears to require implementation evidence rather than a plan alone.
Does a pending extension request stop the deadline?
Do not treat it that way. Track the existing obligation until you have documented agreement to a change. Where the applicable Article 3 interruption provisions govern the request, an extension requires due justification and agreement in writing.
Does an accepted response mean the finding is closed?
Establish what the acceptance covers. A receipt, accepted plan and formal closure are different events. Keep outstanding implementation, effectiveness and review decisions visible until you have evidence of their disposition.
If the date in your letter is clear but the required deliverable is not, resolve that distinction before building the schedule. Talk to Dovetail about your findings response.
