Vigilance under the MDR and IVDR: Serious Incidents, the 2, 10 and 15-Day Deadlines, MIR Forms and Trend Reports

The rules sit in MDR Articles 87 to 92 and IVDR Articles 82 to 87, which have applied since 26 May 2021 (MDR) and 26 May 2022 (IVDR).

This page explains the definitions, the day count, the MIR form, trend and summary reports, and where reports go as of 6 November 2026. In France the field is called materiovigilance, the term the French competent authority ANSM uses for its vigilance contact.

What Vigilance Covers under Both Regulations

Vigilance is the part of the post-market rules of both regulations that governs how manufacturers report serious incidents and field safety corrective actions, how trends are reported and how serious incidents are analysed: MDR Articles 87 to 92 and IVDR Articles 82 to 87. In the MDR they sit in Chapter VII (Articles 83 to 100), and both regulations apply directly in every member state, without transposition.

Each MDR vigilance article has an IVDR counterpart five numbers lower, and the table marks the provisions a future EUDAMED vigilance notice brings into effect; the same chapter structure runs through the EU MDR and IVDR as a whole.

Notice provisions: MDR Article 123(3)(d), IVDR Article 113(3)(f); they also name MDR Article 86(2) and IVDR Article 81(2).

Incident, Serious Incident and Serious Public Health Threat

An incident under MDR Article 2(64) is any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, any inadequacy in the information supplied by the manufacturer and any undesirable side-effect. A serious incident directly or indirectly led, might have led or might lead to death, a temporary or permanent serious deterioration of health, or a serious public health threat (MDR Article 2(65), IVDR Article 2(68)).

A serious public health threat is an event which could result in imminent risk of death, serious deterioration in health or serious illness, may require prompt remedial action, and may cause significant morbidity or mortality or is unusual or unexpected for the place and time (MDR Article 2(66), IVDR Article 2(69)). The EUR-Lex list of amending acts records no change to MDR Article 2.

The IVDR incident (IVDR Article 2(67)) also covers harm as a consequence of a medical decision, or of action taken or not taken, on the basis of information or results provided by the device; these definitions are set out in the IVDR (Regulation (EU) 2017/746) itself.

What Manufacturers Must Report

Manufacturers report two things under MDR Article 87(1) and IVDR Article 82(1): serious incidents involving devices made available on the Union market, and field safety corrective actions. Expected side-effects are excepted when they are clearly documented in the product information, quantified in the technical documentation and subject to trend reporting.

MDCG 2023-3 rev.2, Q2, explains that a report is due when three criteria are met: an incident occurred (A), it led or might lead to a serious outcome (B), and a causal relationship with the device is established, reasonably possible or suspected (C). The same document, Q12, explains that "unanticipated" means a condition not considered in the manufacturer's risk assessment.

The Reporting Deadlines: 2, 10 and 15 Days

The reporting period depends on the outcome: 2 days for a serious public health threat, 10 days for a death or an unanticipated serious deterioration in a person's state of health, and 15 days for every other serious incident, each counted from awareness and each preceded by the duty to report immediately (MDR Article 87(3) to (5), IVDR Article 82(3) to (5)). Four reporting events have their own timing.

Periods as of 6 November 2026; calendar days, day 0 = awareness date (MDCG 2023-3 rev.2 Q14).

Field safety corrective actions are reported before they are undertaken, except in urgency (MDR Article 87(8), IVDR Article 82(8)). The three periods for serious incidents are the same in the EU MDR (Regulation (EU) 2017/745) and in IVDR Article 82.

How the Days Are Counted

MDCG 2023-3 rev.2 Q14 explains that the periods run in calendar days, with the awareness date as day 0, so the period starts at 00:00:01 on the next day and ends at 23:59:59 on its last day, moving to the next working day when that day is a Saturday, Sunday or public holiday (Regulation No 1182/71).

The awareness date is the date on which the first employee or representative of the manufacturer receives the information, including an authorised representative or an outsourced complaint handler, according to MDCG 2023-3 rev.2, Q15.

Initial Reports and Uncertain Cases

A manufacturer may send an incomplete initial report where this is needed to report in time, followed by a complete report (MDR Article 87(6), IVDR Article 82(6)). When reportability is uncertain, the manufacturer still reports within the applicable period (MDR Article 87(7), IVDR Article 82(7)).

Vigilance in Detail: Corrective Actions and Notices in the Field

One detailed page covers what this overview only names: when a field safety corrective action is required, how it is reported and what a field safety notice must contain. It gives the MDR and IVDR articles side by side.

The MIR Form: Version 7.3.1 and the Other Reporting Templates

The MIR (Manufacturer Incident Report) is the form manufacturers use to report serious incidents, and version 7.3.1 has been mandatory since 1 May 2026, according to the Commission's PMSV reporting forms page as of 6 November 2026. The MIR has applied since 1 January 2020 (MDCG 2023-3 rev.2, footnote 7).

The PMSV reporting forms page accepts three builds: SB-10781 (December 2025), SB-11010 (March 2026) and SB-11154 (April/May 2026); earlier builds are not usable. The Commission's MIR changelog lists XSD build SB-11252 of 10 June 2026, which made field 4.3.3.d mandatory.

The Commission's PMSV reporting forms page holds seven further templates:

• field safety corrective action (FSCA) report;
• field safety notice (FSN) template;
• FSN customer reply;
• FSN distributor and importer reply;
• FSN questions and answers;
• trend report;
• periodic summary report.

Trend Reporting and the Statistically Significant Increase

MDR Article 88(1) requires manufacturers to report any statistically significant increase in the frequency or severity of incidents that are not serious incidents, or of expected undesirable side-effects, that could significantly affect the benefit-risk analysis; IVDR Article 83(1) adds expected erroneous results. The increase is established against their foreseeable frequency or severity. Under MDR Article 88(1), the trend report goes through the electronic system of MDR Article 92, whose EUDAMED module is not yet in use.

The method for detecting such an increase and the observation period are set out in the post-market surveillance plan (MDR Article 88(1), second subparagraph, and MDR Annex III Section 1(b)). The trend report template sits on the PMSV reporting forms page.

Periodic Summary Reports and the Coordinating Authority

Similar serious incidents with the same device or device type can be reported in periodic summary reports instead of one by one, when the coordinating competent authority agrees with the manufacturer on the format, content and frequency (MDR Article 87(9), IVDR Article 82(9)). The option covers three cases: the root cause has been identified, a field safety corrective action has been implemented, or the incidents are common and well documented.

Under the MDR, the coordinating competent authority is by default the authority of the member state in which the manufacturer has its registered place of business (MDR Article 89(9)). On the IVDR side, the analysis of serious incidents and field safety corrective actions sits in IVDR Article 84.

Where Reports Go: National Channels and the Electronic System

As of 6 November 2026, serious incident reports go through national channels, because the EUDAMED vigilance and post-market surveillance module is still in development and has no Official Journal notice. The module has no voluntary phase and is one of the six modules of EUDAMED under the MDR and IVDR.

Until the notice applies, the Directive vigilance provisions and the national processes continue (MDR Article 123(3)(d), last subparagraph, MDR Article 122, IVDR Article 112(a)). MDCG 2021-1 rev.1 (May 2021, MDR) and MDCG 2022-12 (July 2022, IVDR) explain the interim practice (Commission Q&A on the gradual roll-out of EUDAMED, Q13).

The Commission's list of national vigilance contact points is in its September 2026 edition as of 6 November 2026.

The German Reporting Route

In Germany the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) performs the tasks of MDR Articles 87 to 90 and IVDR Articles 82 to 85 centrally (§ 71(1) and § 85(2) of the Medizinprodukterecht-Durchführungsgesetz, MPDG, the Medical Devices Law Implementation Act), and manufacturers e-mail the completed MIR to mp-vigilanz@bfarm.de. The full national picture is on MDR and IVDR in Germany.

The Paul-Ehrlich-Institut (PEI) is competent for IVDs that fall under IVDR Annex VIII Rules 1, 2 and 3(a) to (e) and (g) (§ 85(3) MPDG).

The MDCG Vigilance Q&A and the Device-Specific Templates

MDCG 2023-3 rev.2 (January 2025) is the MDCG's question-and-answer document on vigilance terms and concepts under both regulations, and it replaces the earlier versions of February 2023 and October 2024 as the current revision on the Commission list as of 6 November 2026. MDCG 2024-1 (January 2024) is the device-specific vigilance guidance (DSVG) template, applied in DSVG 01 to 05.

MDCG guidance is not legally binding (MDR Articles 103 and 105, IVDR Articles 98 and 99). The table lists the vigilance documents; every other document is listed in the MDCG guidance register.

Documents as listed on the Commission MDCG guidance page, topic PMSV, as of 6 November 2026.

Vigilance Status Summary

As of 6 November 2026, the 2, 10 and 15-day periods apply unchanged, MIR 7.3.1 is the mandatory form, and the EUDAMED vigilance module has no Official Journal notice, so reports go through national channels. When the notice is published, the vigilance obligations tied to the electronic system apply 6 months later (MDR Article 123(3)(d), IVDR Article 113(3)(f)). Open reports then continue in EUDAMED without retrospective registration (Commission Q&A, Q13).

A change to the periods is pending: Commission proposal COM(2025) 1023 of 16 December 2025 (2025/0404(COD)), at the stage "Awaiting committee decision" in the European Parliament's SANT committee as of 6 November 2026; not law. The proposal would allow 30 days instead of 15 for serious incidents other than a serious public health threat, a death or a serious deterioration in health.

The past procedural events include the SANT draft report of 30 June 2026, and every amending act is listed under MDR and IVDR amendments.

What Vigilance Reporting Does Not Cover

Vigilance covers serious incidents, field safety corrective actions and trends; it does not replace the wider post-market surveillance system, and it is not the regime for medicines.

Where Vigilance Ends and Surveillance Begins

Vigilance reports single serious incidents and trends, while post-market surveillance is the manufacturer's systematic procedure to proactively collect and review experience gained from its devices (MDR Article 2(60), IVDR Article 2(63)).

Market surveillance is the competent authorities' check that devices comply (MDR Article 2(61), IVDR Article 2(64)). The manufacturer's system itself is explained under post-market surveillance under the MDR and IVDR.

Does MEDDEV 2.12-1 Rev.8 Still Apply?

No: MDCG 2023-3 rev.2, footnote 1, states that MEDDEV 2.12-1 rev.8 is obsolete under the Regulations.

How the EU Deadlines Compare with US Reporting

The US rule for manufacturer reports is 30 calendar days (21 CFR 803.50(a)), with a 5-work-day report under 21 CFR 803.53, against 2, 10 or 15 calendar days under MDR Article 87 and IVDR Article 82.

The other differences are set out in the EU MDR vs FDA comparison.

Devices Still Certified under the Directives

The vigilance rules of the MDR and the IVDR also apply to legacy devices still placed on the market under a Directive certificate (MDR Article 120(3d), IVDR Article 110(3d)), in place of the corresponding Directive requirements.