MedTech Europe on risk based approach PMCF

MedTech Europe has raised concerns to the European Commission and the MDCG about how the EU Medical Devices Regulation (MDR) post-market clinical follow-up (PMCF) requirements are being applied. In particular, MedTech refers to low-risk devices with well-established safety records. Manufacturers report that regulatory authorities and Notified Bodies expect PMCF clinical investigations for most devices by default, regardless of their risk level. This approach, they argue, ignores the MDR’s principle that PMCF should be proportionate to the device’s risk, intended use, and existing safety evidence. Manufacturers also note that real-world factors, such as differences in clinical practice and patient characteristics, make it unrealistic to gather clinical data for every device variant (e.g., different sizes or configurations). Instead, PMCF should focus on variants with higher risk profiles or where safety signals have emerged. Consequently, the current expectations risk forcing manufacturers to withdraw long-standing, safe “legacy” devices from the market.

In a recent paper, MedTech Europe calls for a more pragmatic, risk-based approach to PMCF, ensuring clinical investigations are conducted only when truly necessary.

The MDR does foresee a risk-based approach to PMCF

The MDR already supports a risk-based approach to post-market clinical follow-up (PMCF):

• Article 61.1 requires manufacturers to define and justify an appropriate level of clinical evidence based on the device’s characteristics and intended use.
• Article 61.4 specifies that high-risk devices require clinical investigations, with exceptions defined in the Regulation.
• Annex XIV, Part B lists various PMCF methods, including user feedback, literature reviews, registries, and PMCF studies.

Additionally, MDCG guidance (2020-7 and 2024-10) reinforces that PMCF can include diverse sources of data (e.g., registries, real-world evidence, surveys) and should be well-structured. However, neither the Regulation nor the MDCG guidance include a definition of “PMCF activity”, which leads to ambiguity.

PMCF impact on healthcare professionals

Healthcare professionals (HCPs) are increasingly burdened by excessive requests for PMCF data, even for long-established devices that have been safely used for decades. Many of these devices were approved based on equivalence under previous regulations (MDD/AIMDD), and conducting new clinical investigations on them now is seen as ethically questionable, offering no new patient benefit or scientific interest.

MedTech Europe highlights that disproportionate PMCF expectations negatively affect HCPs, patients, and manufacturers. In this context, the association proposes a more balanced, risk-based approach in the following case studies and recommendations.

MedTech proposes several measures to promote a risk-based approach

MedTech Europe measures to promote a risk-based, proportionate approach to PMCF for low-risk devices with proven safety include:

• Ensure harmonised implementation of MDCG 2020-6 guidance so PMCF requirements match device risk and purpose.
• Apply MDCG 2020-6 to all devices (not just legacy ones) for consistent evidence expectations.
• Define PMCF activities in the MDR to clearly distinguish routine PMCF from PMCF clinical investigations.
• Emphasise existing post-market and real-world data (including non-EU data) in PMCF assessments.
• Use a pragmatic, risk-based approach to data collection for device variants, recognising similarities and maintaining focus only where safety profiles differ.

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References:

MedTech Europe (2025). Risk based approach to Post Market Clinical Follow up (PMCF). Retrieved on 07/11/2025.