EU MDR ARTICLES 83–86

Post-Market Surveillance Under EU MDR — PMS Plan, PSUR and PMCF

EU MDR imposes ongoing post-market surveillance obligations on every manufacturer. This is not a one-time task — it is a permanent, structured process that must be maintained throughout the lifetime of your device on the EU market.

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What EU MDR requires

Post-market surveillance obligations under EU MDR 2017/745

Articles 83 to 86 of EU MDR establish mandatory post-market surveillance requirements for all manufacturers. The system must be proactive, systematic and based on a documented plan — not reactive to complaints alone.

PMS Plan — Article 84

Every manufacturer must establish and document a post-market surveillance plan before placing a device on the market. The plan must specify the methods and processes used to collect and analyse real-world data on device performance, safety and clinical outcomes.

Data sources and collection methods
Complaint handling procedures
Vigilance data review
Literature surveillance strategy
PMCF methods where applicable

PSUR — Article 86

The Periodic Safety Update Report summarises all post-market surveillance data collected and assesses whether the benefit-risk profile of the device remains acceptable. Required for Class IIa, IIb and III devices.

Class IIb and III — updated annually
Class IIa — updated every two years
Must be submitted to Notified Body
Links to clinical evaluation update

PMS Report — Article 85

Class I manufacturers prepare a Post-Market Surveillance Report instead of a PSUR. Less formal than a PSUR but must still document the conclusions drawn from PMS data and justify any actions taken.

PMCF — Annex XIV

Post-Market Clinical Follow-up is required where pre-market clinical data is insufficient or where new information may affect the clinical evaluation. A PMCF plan and evaluation report must be documented and regularly updated.

Our process

How we help you build a compliant PMS system

Gap assessment

We review your existing post-market documentation and identify what is missing or non-compliant against EU MDR Articles 83–86 and Annex XIV requirements.

PMS plan preparation

We write a complete, device-specific PMS plan covering data sources, collection intervals, analysis methodology, signal detection thresholds and escalation procedures.

PSUR or PMS report

We prepare your PSUR or PMS Report based on available post-market data, literature review and complaint analysis — ready for submission to your Notified Body.

PMCF plan and evaluation

Where required, we design a PMCF plan with appropriate study design, define evaluation criteria and prepare the PMCF evaluation report.

Ongoing maintenance

We can manage your PMS system on an ongoing annual basis — ensuring PSUR updates, literature surveillance and PMCF evaluations are completed on schedule.