Once the quality and validity of each available data set is assessed, the clinical data needs to be evaluated to determine whether all products (including different models or sizes or settings) are covered, and whether all indications and/or conditions in which the device is intended to be used are addressed in order to support the continued acceptability of the device’s benefit-risk profile. This assessment will lead to the identification of potential data gaps to be closed with clinical activities such as post-market clinical follow-up (PMCF) clinical investigations.
Are PMCF data needed for CE re-certification under the MDR?
The need for PMCF data will depend on the device itself, the risk classification of the device, the previous clinical evaluation and on the clinical data available for the device.
If, for example the need for a PMCF study was already identified during the previous clinical evaluation process for a medical device, manufacturers are expected to have these activities planned and initiated when it comes to re-certification. Where reasonable, manufactures will also need to provide data from these clinical activities.
Please be aware that during the period of validity of the MDD and AIMDD CE-certificates, the MDR requirements for post-market surveillance (PMS) apply from the MDR date of application on May 26, 2021. This means that, manufacturers are expected to have a PMS system established or updated, including a PMS plan and a PMCF plan, currently by the MDR date of application.
PMCF study data might not necessarily be needed for re-certification (yet). However, as mentioned above, we expect that PMCF activities need to be at least planned and initiated for the majority of the medical devices currently on the market.
Dietmar Falke is Head of Clinical Research at Emergo by UL.
Additional EU MDR and clinical data management resources from Emergo by UL:
- European MDR compliance preparation and resource center
- Clinical Evaluation Report (CER) preparation support
- European post-market clinical follow-up (PMCF) study consulting
- Webinar: Optimizing your PMS and clinical activities for MDR compliance
Related resources for Europe:
- CE Mark Certification for Medical Devices
- Clinical Evaluation Reports (CER) for Medical Devices in Europe
- EU IVDR Gap Assessment and CE Transition for IVD Companies
- EU MDR compliance consulting for cosmetic and aesthetic products
- EU Medical Device Vigilance Reporting in Europe
- EU Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices
- European Authorized Representative for Clinical Trials
- European Authorized Representative for Medical Device Companies
- European MDR 2017/745 Gap Assessment and CE Transition Strategy
- European Union Medical Device Classification
- In Vitro Diagnostics Regulation (EU IVDR) On-Site Training
- IVD Certification and Registration to Obtain CE Marking in Europe
- Medical Device and IVD Emergency Use Routes in Europe
- Medical Device Technical File and Design Dossier for EU CE Marking
- Switzerland Representative for Medical Device Companies
- UKRP and Brexit consulting for medical device companies