In its latest Position Paper (October 2025), MedTech Europe urges regulators and Notified Bodies to adopt a risk-based and proportionate approach to Post-Market Clinical Follow-up (PMCF) activities for medical devices under the MDR 2017/745.
Manufacturers report growing pressure from authorities and Notified Bodies to conduct PMCF clinical investigations for nearly all devices — even long-established, low-risk technologies. MedTech Europe argues that this contradicts the MDR’s intent to align clinical evaluation with risk management and may unnecessarily strain healthcare professionals, patients, and innovation capacity.
Main concerns
- Lack of definition for “PMCF activity” in MDR and MDCG guidance creates uncertainty on when a clinical investigation is truly required.
- Over-interpretation of PMCF obligations leads to excessive studies, consuming clinical research capacity and delaying innovation.
- Ethical and practical challenges arise for example when requesting data from palliative-care patients or long-marketed low-risk devices.
MedTech Europe calls for:
- Harmonised implementation of MDCG 2020-6, ensuring alignment between device class, risk, and PMCF evidence requirements.
- Extension of MDCG 2020-6 beyond legacy devices to all products.
- Formal definition of “PMCF activity” within the MDR revision, distinguishing PMCF studies from other surveillance methods.
- Greater reliance on PMS data and real-world evidence, including sources outside Europe.
A proportional PMCF system ensures safety remains verifiable — without compromising the availability of proven, safe devices.
More info: https://www.medtecheurope.org/resource-library/risk-based-approach-post-market-clinical-follow-up/
At IPN, we help manufacturers design and implement PMCF plans that are data-driven, proportional, and regulator-ready, integrating clinical evaluation, PMS, and risk management effectively.