Post-market surveillance (PMS) — requirements by class

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Regulatory basis - MDR Art. 83–86 / IVDR Art. 78–81. PMS is a proactive, systematic process that all manufacturers must implement. The depth and reporting frequency scale with device risk class.

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Disclaimer - This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.

What is post-market surveillance?

Post-market surveillance (PMS) is the proactive and systematic process of collecting and analysing data on marketed devices to:

Confirm the device's safety and performance throughout its commercial lifetime
Identify previously unknown or underestimated risks
Detect any systematic misuse or off-label use that could affect safety
Determine whether improvements to the device or IFU are needed
Ensure the benefit-risk analysis remains positive

PMS is mandatory for all manufacturers of all device classes and IVD all classes, regardless of conformity assessment route or whether notified body involvement is required. There is no exemption.

PMS system — MDR Art. 83

Manufacturers must establish, document, implement, maintain, and update a PMS system that is an integral part of the QMS. The system must:

Actively gather post-market data from defined sources
Analyse and evaluate the gathered data
Draw conclusions about the need for preventive or corrective action
Feed data back into the risk management file, clinical/performance evaluation, technical documentation, and manufacturing and labelling processes

The PMS system is not a passive complaints log — it is a proactive surveillance programme.

PMS data sources

The PMS plan must identify which data sources will be monitored and how frequently. Standard sources include:

Source	Examples
Customer complaints and feedback	Distributor reports, direct user feedback, help desk queries
Vigilance data	Own serious incidents; published FSCA/recall information for comparable devices
Scientific literature	Systematic literature searches (PubMed, EMBASE, Cochrane)
Clinical registries	National implant registries, disease-specific registries
PMCF / PMPF studies	Structured post-market clinical/performance data collection
EUDAMED public data	Published vigilance reports for similar devices
Social media and online platforms	Patient forums, adverse event reporting channels
Post-market clinical follow-up (MDR)	Structured real-world data collection
Post-market performance follow-up (IVDR)	Ongoing analytical and clinical performance monitoring

PMS requirements by device class

MDR Class I

Requirement	Detail
PMS system	Required
PMS plan	Required
PMS report	Required — updated when necessary (no fixed frequency)
PSUR	Not required
PMCF	Required — but may be justified as not necessary
Notified body review	Not required (Class I self-declaration)

Class I PMS is typically simpler — fewer complaints, less complex devices. But the obligation exists and must be documented.

MDR Class IIa

Requirement	Detail
PMS system	Required
PMS plan	Required
PMS report	Required — updated at minimum when significant new information available; NB reviews at surveillance
PSUR	Not required (PMS report suffices)
PMCF	Required — must be justified if not conducted
Notified body review	PMS report reviewed at NB surveillance audit

MDR Class IIb

Requirement	Detail
PMS system	Required
PMS plan	Required
PMS report	Required
PSUR	Required for implantable Class IIb devices — at minimum every 2 years
PMCF	Required
Notified body review	PSUR/PMS report reviewed at annual surveillance audit

MDR Class III / AIMD

Requirement	Detail
PMS system	Required
PMS plan	Required
PSUR	Required — at minimum annually
PMCF	Required — PMCF plan and evaluation report maintained
Notified body review	PSUR and PMCF reviewed at annual surveillance audit; PSUR submitted to NB via EUDAMED

IVDR PMS requirements by class

IVDR Class A

Requirement	Detail
PMS system	Required
PMS plan	Required
PMS report	Required
PSUR	Not required
PMPF	Required — justified if not conducted

IVDR Class B

Requirement	Detail
PMS system	Required
PMS plan	Required
PMS report	Required
PSUR	Not required
PMPF	Required
NB review	At NB surveillance

IVDR Class C

Requirement	Detail
PMS system	Required
PMS plan	Required
PSUR	Required — at minimum every 2 years
PMPF	Required
NB review	PSUR reviewed at NB surveillance

IVDR Class D

Requirement	Detail
PMS system	Required
PMS plan	Required
PSUR	Required — at minimum annually
PMPF	Required
NB review	Annual review; PSUR submitted to NB

The PMS–technical documentation feedback loop

PMS data must flow back into the technical documentation. When PMS identifies:

New hazards: update the risk management file
Changed risk estimates: update risk management file and benefit-risk analysis
New clinical/performance data: update CER / performance evaluation report
GSPR compliance concerns: update GSPR cross-reference table
Labelling adequacy issues: update IFU and labels

This creates the lifecycle loop that is central to MDR/IVDR's approach — the technical documentation reflects the device as it is known today, not just as it was at CE marking.

Official references

Reference	Description
MDR Art. 83	PMS system requirements
MDR Art. 84	PMS plan requirements
MDR Art. 85	PSUR requirements
MDR Art. 86	PMS report requirements
IVDR Art. 78–81	IVDR PMS requirements
MDR Annex III	Post-market technical documentation
MDCG 2022-21	PSUR guidance
MDCG 2020-7	PMCF plan and evaluation report template

What is post-market surveillance?​

PMS system — MDR Art. 83​

PMS data sources​

PMS requirements by device class​

MDR Class I​

MDR Class IIa​

MDR Class IIb​

MDR Class III / AIMD​

IVDR PMS requirements by class​

IVDR Class A​

IVDR Class B​

IVDR Class C​

IVDR Class D​

The PMS–technical documentation feedback loop​

Related pages​

Official references​