Post-Market Surveillance under the MDR and IVDR: The PMS System, the Plan, PMS Reports and PSURs

Annex III of each regulation sets out the content of the plan and places the reports in the technical documentation.

This page covers the shared definition, the PMS document each class needs, the PMS system, the six information sources and 10 minimum elements of the PMS plan, the PMS report, the notified-body audit at least once every 12 months, legacy devices, MDCG 2025-10 and the pending targeted revision.

What Is Post-Market Surveillance?

Post-market surveillance is the manufacturer's duty to keep watching a device after it has been placed on the market, made available on the market or put into service, so that any need for corrective or preventive action is found and acted on immediately. "Post-market" refers to that period after the device reaches the market.

Both regulations entered into force on 25 May 2017 (MDR Article 123(1), IVDR Article 113(1)). The PMS articles have applied since 26 May 2021 under the MDR (Articles 83 to 86) and since 26 May 2022 under the IVDR (Articles 78 to 81). Both are regulations, directly applicable in every member state without national transposition, and PMS is one of the obligations set out in the EU MDR and IVDR.

The Legal Wording Shared by Both Regulations

MDR Article 2(60) and IVDR Article 2(63) define post-market surveillance in identical words: "all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions".

The wording fixes three points. The manufacturer carries the duty, and other economic operators, such as authorised representatives, importers and distributors, cooperate with it. The activity is a systematic procedure kept up to date, not a one-off review. And the collection is proactive, aimed at corrective or preventive action applied immediately.

Where PMS Sits Among the Manufacturer's Obligations

MDR Article 10(10) and IVDR Article 10(9) make PMS a general obligation of every manufacturer, carried out under Article 83 of the MDR or Article 78 of the IVDR.

The quality management system has 13 minimum aspects, points (a) to (m) of the third subparagraph of MDR Article 10(9) and of IVDR Article 10(8), and MDR Article 10(9)(i) names the post-market surveillance system under Article 83 among them, next to risk management (point (e)) and the reporting of serious incidents and field safety corrective actions (point (k)). The quality management system is proportionate to the risk class and the type of device (MDR Article 10(9)).

MDR and IVDR Article 15(3)(c) make the person responsible for regulatory compliance (PRRC) responsible for ensuring that the PMS obligations of MDR Article 10(10) and IVDR Article 10(9) are complied with. PMS is one of five minimum responsibilities, points (a) to (e) of Article 15(3) of each regulation; the other four duties are explained under the person responsible for regulatory compliance.

The PMS Documents by Class at a Glance

The class decides the report: a PMS report for MDR class I and IVDR class A and B devices, and a PSUR for MDR class IIa, IIb and III and IVDR class C and D devices, while every device needs a PMS system and a PMS plan. The table below sets out, for each class of each regulation, the document, how often it is updated, who may ask for it and the article.

Every device also needs a PMS system and a PMS plan (MDR Articles 83 and 84, IVDR Articles 78 and 79). Status of the rules as of 6 November 2026.

The PMS plan and the PSUR or PMS report are the two parts of Annex III, "Technical documentation on post-market surveillance", in each regulation: Section 1 covers the plan (MDR Article 84, IVDR Article 79), and Section 2 covers the PSUR (MDR Article 86, IVDR Article 81) and the PMS report (MDR Article 85, IVDR Article 80). For class IIa, "when necessary and at least every two years" sets a minimum, not a fixed two-year cycle.

Post-Market Surveillance in Detail: PSURs and Market Surveillance by Authorities

Two detailed pages cover what this overview summarises: the PSUR, with its content, timing and guidance, and the market surveillance that competent authorities carry out under MDR Articles 93 to 100 and IVDR Articles 88 to 95. This overview stays at the level of which class needs which document. The table lists each page with the question it answers and its legal hook.

The PMS System under MDR Article 83 and IVDR Article 78

MDR Article 83 and IVDR Article 78 require each manufacturer to have a PMS system for each device, as an integral part of its quality management system. The system holds the plan, the data collection and the reports described below. Article 83 opens Chapter VII of the EU MDR (Regulation (EU) 2017/745), which covers post-market surveillance, vigilance and market surveillance (Articles 83 to 100).

One System per Device, Proportionate to the Risk Class

The PMS system is set up for each device and is proportionate to the risk class and appropriate for the type of device (MDR Article 83(1); IVDR Article 78). Proportionality governs the scope of the system, not its existence: no class is without a PMS system, which is why the class table above lists a PMS report or a PSUR for every class of both regulations.

Harmonised standards can give a presumption of conformity for the system and process requirements of the regulations, and PMS systems are named among them (MDR Article 8(1) second subparagraph; IVDR Article 8(1) second subparagraph). The presumption applies only to standards whose references are published in the Official Journal lists of Implementing Decisions (EU) 2021/1182 for the MDR and (EU) 2021/1195 for the IVDR, as amended.

What the Collected Data Must Be Used For

MDR Article 83(3) lists eight uses, points (a) to (h), for the data the PMS system gathers. The eight uses are listed below in the order of the article.

• (a) Updating the benefit-risk determination and improving the risk management.
• (b) Updating the design and manufacturing information, the instructions for use and the labelling.
• (c) Updating the clinical evaluation.
• (d) Updating the summary of safety and clinical performance under Article 32.
• (e) Identifying needs for preventive, corrective or field safety corrective action.
• (f) Identifying options to improve the usability, performance and safety of the device.
• (g) Contributing to the post-market surveillance of other devices, where relevant.
• (h) Detecting and reporting trends under Article 88.

MDR Annex I Section 3(e) requires the manufacturer to evaluate information from the production phase and from PMS. The methodology and the observation period for trend reporting are specified in the PMS plan (MDR Article 88(1) second subparagraph; IVDR Article 83(1)). IVDR Article 78 contains a corresponding list of uses for IVDs. The risk management steps belong to the general safety and performance requirements of Annex I.

The PMS Plan under MDR Article 84 and IVDR Article 79

The PMS system rests on a PMS plan, whose content Annex III Section 1 of each regulation sets out, and the plan is part of the technical documentation, with one MDR exception explained below. No MDCG template for the PMS plan appears on the Commission's MDCG guidance list as of 6 November 2026, so Annex III itself serves as the checklist.

The Six Information Sources the Plan Covers

MDR Annex III Section 1(a) lists six sources of information the plan collects and uses. The table below names each source and what it covers.

IVDR Annex III follows the same structure for in vitro diagnostic devices, with PMPF in the place of PMCF, and its text is part of the IVDR (Regulation (EU) 2017/746).

The Ten Elements Every Plan Must Contain

MDR Annex III Section 1(b) lists 10 elements the plan must contain at least, from the proactive and systematic collection of information to the PMCF plan or a justification why PMCF is not applicable.

The indicators and threshold values are the elements that trigger action: they are used to reassess the benefit-risk analysis. The table below lists the 10 elements in the order of the annex.

In the file, the plan and its 10 elements sit in Annex III, which the regulations head "Technical documentation on post-market surveillance" and keep apart from Annex II, "Technical documentation". Annex III is the post-market part of the MDR and IVDR technical documentation.

Clinical and Performance Evidence Updates Inside the Plan

The PMS plan carries the plan for updating the clinical or performance evidence after placing on the market: PMCF under the MDR and PMPF under the IVDR. The two follow-up processes are listed below.

• PMCF under the MDR: a continuous process that updates the clinical evaluation and is addressed in the PMS plan (MDR Annex XIV Part B Section 5).
• PMPF under the IVDR: a continuous process that updates the performance evaluation and is addressed in the PMS plan (IVDR Annex XIII Part B Section 4); the PMPF plan is part of the PMS plan (IVDR Annex III Section 1(b)).

Where a follow-up does not apply to a device, the PMS plan contains a justification why PMCF or PMPF is not applicable instead (MDR and IVDR Annex III Section 1(b)). The content of each follow-up plan is set out in MDR Annex XIV Part B and IVDR Annex XIII Part B.

The One Exception to the Plan's Place in the File

Under MDR Article 84 the PMS plan is part of the technical documentation referred to in Annex II for every device except custom-made devices. IVDR Article 79 contains no such exception, so the PMS plan of every IVD is part of its technical documentation.

MDCG 2025-10 section 3.2 explains that a PMS system and a PMS plan are still expected in practice for custom-made devices, and that the PMS report of a class I custom-made device and the PSUR of a class IIa, IIb or III custom-made device both go into the documentation of MDR Annex XIII Section 2. That documentation and the Annex XIII statement are explained under custom-made devices under the MDR.

The PMS Report for Lower-Risk Devices

The lowest classes of each regulation document their PMS results in a PMS report rather than a PSUR: MDR class I under Article 85 and IVDR class A and B under Article 80. The two articles share one pattern, a report updated when necessary and shown on request, and differ in who may ask for it.

The Article 85 Report for the Lowest-Risk Devices

Manufacturers of MDR class I devices prepare a PMS report, update it when necessary and make it available to the competent authority upon request (MDR Article 85). A PMS report for medical devices is therefore the class I document of post-market surveillance in Annex III Section 2.

The report is not a PSUR. MDR Article 86 requires PSURs for class IIa, IIb and III devices, so "PSUR for class I" has no basis in the MDR. Article 85 also sets the update as "when necessary" rather than at a fixed interval, so a set cycle such as every three years comes from no article of the regulation. The class itself is set out under class I medical devices under the MDR.

The Article 80 Report for Low-Risk IVDs

Manufacturers of IVDR class A and class B devices prepare a PMS report, update it when necessary and make it available to the notified body and the competent authority upon request (IVDR Article 80).

The IVDR adds the notified body as a recipient. Class B devices and sterile class A devices go through a notified body in their conformity assessment, the sterile class A route limited to the sterile aspects, while non-sterile class A devices carry no IVDR certificate.

How Notified Bodies Check the PMS System

For devices certified under MDR Annex IX, the notified body carries out a surveillance assessment at least once every 12 months, and the audit covers the approved quality management system and the PMS plan (MDR Annex IX Section 3.3). The 12-month interval is a minimum, and the PMS plan is named in the audit rule itself. Which bodies are designated for which devices is shown under notified bodies for the MDR and IVDR.

For a certified device, the plan also sits in the technical documentation the notified body works with, since MDR Article 84 and IVDR Article 79 make it part of that documentation.

PMS Duties for Devices Placed under the Old Directives

Devices still placed on the market under a Directive certificate or declaration during the transition follow the PMS rules of the regulations: MDR Article 120(3d) and IVDR Article 110(3d) apply the requirements on post-market surveillance, market surveillance, vigilance and registration of economic operators and of devices to legacy devices.

For the PSUR and the PMS report, a legacy device keeps the class it had under the Medical Devices Directive (MDD). The Commission Q&A on Regulation (EU) 2023/607 (Q4) and MDCG 2021-25 rev.1 of October 2024 (section 3.1) explain this, and the Annex of MDCG 2021-25 rev.1 applies the Article 85 PMS report to MDD class I legacy devices and the Article 86 PSUR to MDD class IIa, IIb and III legacy devices. The end dates and their conditions are set out under legacy devices under the MDR.

MDR legacy end dates depend on the conditions of MDR Article 120(3c), and IVDR legacy end dates on the class of the device under IVDR Article 110.

MDCG 2025-10 on Proactive Data Collection

MDCG 2025-10, published by the MDCG in December 2025, is the first general guidance on post-market surveillance for both medical devices and IVDs, and it covers MDR Articles 83 and 84, IVDR Articles 78 and 79 and Annex III. Its full title is "Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices". The Commission lists it under the topic "Post-Market Surveillance and Vigilance (PMSV)" on its MDCG guidance list, announced it in a news item of 19 December 2025, and, as of 6 November 2026, has not revised it.

Section 4 of MDCG 2025-10 explains that the manufacturer actively seeks information and does not merely wait for complaints to arrive. MDCG guidance is not legally binding (MDR Articles 103 and 105, IVDR Articles 98 and 99), and notified bodies take it into consideration under Annex VII Section 1.6.2 of both regulations. MDCG 2025-10 is listed with its revision in the MDCG guidance register.

What MDCG 2025-10 Leaves Out

MDCG 2025-10 section 2 leaves out the preparation of the PSUR and of the PMS report, for which it points to MDCG 2022-21, and the health institution exemption of Article 5(5) of the regulations. MDCG 2022-21, published in December 2022 and not revised as of 6 November 2026, is the PSUR guidance and covers the MDR only. Its content belongs to the PSUR page listed above.

Proposed Changes to the PMS Rules

The targeted revision of both regulations, Commission proposal COM(2025) 1023 of 16 December 2025 (procedure 2025/0404(COD)), is pending: as of 6 November 2026 it is at the stage "Awaiting committee decision" in the European Parliament, with the SANT committee as lead committee, and it is not law. The past procedural events recorded in the Legislative Observatory include the draft report of 30 June 2026.

The proposal would change four points that touch PMS. It would reduce PSUR frequencies. It would replace MDR Article 10(9) with a text without the list of quality management system aspects (a) to (m). It would drop the separate PMCF evaluation report and PMPF report, with the findings documented in the clinical or performance evaluation report and the justification for not applying PMCF or PMPF kept in the PMS plan. And it would allow surveillance audits every two years where justified. Every amending act and the proposal are listed under MDR and IVDR amendments.

MDR Articles 83 to 86 and IVDR Articles 78 to 81 apply unchanged until an amending regulation is adopted and published.

How PMS Differs from Vigilance and Market Surveillance

PMS is the manufacturer's own continuous collection and review of data, vigilance is the reporting of serious incidents and field safety corrective actions, and market surveillance is what the authorities do.

Where Vigilance Takes Over

The vigilance rules of MDR Articles 87 to 92 and IVDR Articles 82 to 87 apply when PMS data show a serious incident or the need for a field safety corrective action. The reporting deadlines and the trend report are set out under vigilance under the MDR and IVDR. The electronic system on vigilance and post-market surveillance (MDR Article 92, IVDR Article 87) is in development in EUDAMED, with no notice in the Official Journal and no voluntary phase as of 6 November 2026, so reports go through national channels meanwhile (MDR Article 123(3)(d), IVDR Article 113(3)(f)).

Where the Authorities Take Over

Market surveillance is carried out by the authorities, which check and ensure that devices comply with the requirements and do not endanger health, safety or public interest protection: competent authorities under MDR Article 2(61) and Articles 93 to 100, public authorities under IVDR Article 2(64) and Articles 88 to 95. One document they may ask for is the PMS report, which MDR Article 85 and IVDR Article 80 oblige the manufacturer to make available on request.