Post-market surveillance: PMS, PSUR and PMCF under the MDR

Under the MDR, a medical device does not stop being assessed after CE marking: its post-market surveillance is an obligation in its own right, as structured as its design. This guide presents the system, its documents and their deadlines.

The surveillance system (Article 83)

Each manufacturer plans, establishes, documents, implements, maintains and updates a post-market surveillance system:

• proportionate to the risk class and appropriate for the type of device;
• integrated into the quality management system;
• designed to actively and systematically gather, record and analyse data on the quality, performance and safety of the device throughout its lifetime.

The data gathered are used to update the benefit-risk determination and risk management, the design, manufacturing information, instructions for use, clinical evaluation and SSCP, to identify needs for corrective or preventive action and to detect trends.

The surveillance plan (Article 84 and Annex III)

The plan is part of the technical documentation. It notably sets out:

• processes to collect information: serious incidents, field safety corrective actions, non-serious incidents and undesirable side-effects, complaints, specialist literature, databases and registers, publicly available information on similar devices;
• methods for assessing the data collected;
• indicators and thresholds used to continuously reassess the benefit-risk ratio;
• the statistical methods used;
• communication tools with authorities, the notified body, economic operators and users;
• references to procedures for surveillance reports, PSURs and trend reports;
• tools to trace devices that may need corrective action;
• the PMCF plan, or justification for its absence.

The surveillance report: class I (Article 85)

For class I devices, the manufacturer prepares a post-market surveillance report summarising the results and conclusions of the data analysis, with the rationale for any preventive and corrective actions taken. It is updated when necessary and made available to the competent authority on request.

The PSUR: classes IIa, IIb and III (Article 86)

The periodic safety update report presents:

• the conclusions of the benefit-risk determination;
• the main findings of the PMCF;
• the volume of sales and an estimate of the size and characteristics of the population using the device and, where practicable, its usage frequency.

Class	Minimum frequency	Recipient
IIa	When necessary, and at least every two years	Kept available to the notified body and authorities
IIb	At least annually	Kept available; submitted to the notified body for implantables
III	At least annually	Submitted to the notified body, which evaluates it

MDCG 2022-21 specifies the PSUR content and presentation.

PMCF: the clinical part

Post-market clinical follow-up (Annex XIV, Part B) is a continuous process that updates the clinical evaluation. Its methods may be general (gathering clinical experience, user feedback, literature review) or specific (follow-up studies, registries). Its results go into a PMCF evaluation report and feed the PSUR and the clinical evaluation. PMCF plan and report templates are provided by MDCG 2020-7 and MDCG 2020-8.

Trends and vigilance

Post-market surveillance feeds two related obligations:

• the trend report (Article 88), when a statistically significant increase in the frequency or severity of non-serious incidents or expected side-effects is identified;
• vigilance (Articles 87 to 92), for serious incidents and field safety corrective actions, covered in our guide on materiovigilance and the MDR vigilance system.

Under the IVDR

The IVDR follows the same architecture (Articles 78 to 81): a surveillance report for classes A and B, a PSUR updated at least annually for classes C and D, and post-market performance follow-up (PMPF) instead of PMCF.

Frequent findings

1. A generic plan, identical for all devices, with no device-specific indicators or thresholds.
2. Purely reactive surveillance, limited to complaints, whereas the MDR requires proactive collection.
3. A PSUR with no conclusion on the benefit-risk ratio, or late against its frequency.
4. Data that never reach risk management and clinical evaluation.
5. Similar devices ignored, when their published incidents shed light on your own risks.

Post-market surveillance also means following authority publications on similar devices and new MDCG documents: one of the uses of medical device regulatory monitoring.