PMCF nach Anhang XIV Teil B der MDR: Gibt es Ausnahmen?

Post-market clinical follow-up (PMCF) is one of the central obligations for medical device manufacturers under the Medical Device Regulation (MDR). Many manufacturers ask whether there are situations in which PMCF is not required or can be reduced. The answer is nuanced: Annex XIV Part B of the MDR does not provide for blanket exemptions, but it does allow product-specific flexibility. According to the current consolidated version of the MDR as of January 2026 (Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, consolidated version as of 01/01/2026), the following applies:

PMCF as a continuous process without general exemptions

The MDR, Annex XIV Part B, defines post-market clinical follow-up as a “continuous process that updates the clinical evaluation referred to in Article 61 and Part A of this Annex”.

The manufacturer must “proactively collect and evaluate clinical data from the use of a CE-marked device” in order to confirm safety and performance, to monitor risks and to detect new or changed risks at an early stage. The MDR explicitly requires a “plan for the post-market clinical follow-up”, which sets out the methods to be used, their suitability, specific objectives and a detailed timetable. An “evaluation report on the post-market clinical follow-up” becomes part of the technical documentation and the clinical evaluation report.

The Regulation therefore establishes a fundamental obligation to perform PMCF, irrespective of risk class or device type.

No blanket exemptions, but risk-based design

Annex XIV Part B does not provide for general exemptions. Every manufacturer must have a product-specific PMCF plan including methods, objectives and timelines. However, scope and intensity may vary on a risk-based basis: from systematic literature review and analysis of registry data through to prospective PMCF studies, depending on risk class, degree of innovation and existing clinical evidence. Notified Bodies assess the suitability (“appropriateness”) of PMCF and may request additional studies pursuant to Article 56(3) MDR. “Appropriate” in this context means adequate and proportionate in light of the risk, degree of innovation and the available evidence.

PMCF – practical implications

The Notified Body assesses whether the PMCF plan is adequate and whether post-market studies are included to ensure safety and performance. Early, transparent alignment helps to avoid subsequent requests and enables efficient resource planning as part of the clinical evaluation under Article 61 MDR.

Recommendation

For each device, develop a scientifically sound, risk-based PMCF plan, provide a clear rationale for your choice of methods, and agree this plan with your Notified Body at an early stage in order to create regulatory certainty and accelerate the certification process.

We will gladly support you in designing and conducting your post-market clinical follow-up. Contact us for a non-binding initial consultation!

Source:
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (consolidated version as of 01/01/2026, CELEX:02017R0745-20260101)

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(Status: January 2026)

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