Why PMCF is Mandatory Under EU MDR
Regulatory Background
Because of many device failures leading to serious adverse events under the MDD, the EU Commission legislated a new regulation to replace the former EU Medical Device Directive (MDD) to ensure clinical safety and performance of medical devices throughout their product lifetime. The premise of MDR is that pre-market clinical trials or studies alone would not provide sufficient evidence for clinical safety and performance in real-life situations throughout a device's lifetime.
Thus, MDR defines Post-Market Clinical Follow-Up (PMCF) as a continuous process of updating the clinical evaluation (see EU MDR 2017/745: Annex XIV, Part B). For Class III and IIb implantable devices, the PMCF report is required every year. For class IIa and IIb non-implantable devices, PMCF is needed when there is not sufficient clinical evidence to support all clinical claims.
Key Distinction from MDD
Although PMCF was mentioned in the MDD, it was not emphasized nor clearly stated as a mandatory element. Now, under MDR, PMCF is mandatory unless you can justify that no PMCF is needed for your product.
The Importance of PMCF for CE Certification
PMCF is required to collect data to fill any data gaps in the Clinical Evaluation Report (CER). If your CER does not provide sufficient clinical data to support your clinical claims, PMCF is the pathway to establish sufficient clinical evidence. If you fail to provide a PMCF plan and PMCF report with evidence intended to be generated, you would risk losing your CE certificate.
Critical Business Impact
Thus, PMCF is critical for your business in the EU market. This applies to both the transition from MDD to MDR and afterwards. Because of a number of device failures leading to serious incidents, the European Commission legislated the medical device regulation that puts the highest priority on clinical safety and performance of medical devices marketed in the EU.
Continuous monitoring is necessary throughout the product lifecycle in real-life settings since limited pre-market clinical trials/studies cannot provide evidence of safety and performance for all intended uses and target patients for the long-term. Thus, PMCF has been set as a means to establish such evidence and update risks and benefits when any emerging risks are found during the product's lifecycle.
What PMCF is Needed for Your Device?
PMCF Plan Submission Requirements
Although you are required to submit a PMCF plan along with your CER to the Notified Body (NB), the type of PMCF activities needed depends upon:
Risk Classification
The device's risk classification (Class I, IIa, IIb, or III) determines the level of PMCF required and the frequency of reporting.
Data Deficiency Level
The extent of missing clinical data and gaps in your CER determines the scope and type of PMCF activities needed.
Market Duration
The length of time the product has been in the market affects the type of PMCF data that can be collected and the evidence available.
If you are in the process of transitioning from MDD to MDR, you must already have a PMCF Plan along with the CER. You may receive deficiency feedback from the NB regarding clinical evidence for your clinical claims. The NB does not instruct you what PMCF activity to fill those gaps.
Addressing NB Deficiency Feedback
If you receive such data deficiency feedback from the NB, you should review not only the data that are missing but also the clinical claims that have been set and their parameters, and the literature search protocol that has been established.In some cases, insufficient clinical evaluation has been conducted based upon State-of-the-Art (SOTA) evaluation. Clinical claims parameters, including acceptance rate or threshold values, need to be based upon SOTA evaluation. For each clinical claim, if there is no data related to your own product, you will need to collect those data through PMCF unless you can prove safety and performance of your product on the particular claim without conducting PMCF.
Types of PMCF Activities
There are several options for PMCF activities depending on what evidence level is required and the feasibility of the activity:
PMCF Activity Options
- PMCF Surveys: Collect patient or physician feedback through structured questionnaires
- Registries: Systematic collection of data from multiple sites or centers
- PMCF Studies: Prospective or retrospective clinical studies to gather specific safety and performance data
Clinical Evidence Hierarchy
The hierarchy of clinical evidence determines the weight and acceptance of different PMCF activity types. According to MDCG 2020/6 Guidance for Sufficient Clinical Evidence (Appendix III):
Evidence Ranking
- Rank 1-2: Interventional clinical studies (depending on study design)
- Rank 3: Registries
- Rank 4: High-quality surveys
- Rank 8: General surveys
Understanding this hierarchy is crucial when planning your PMCF activities, as Notified Bodies will expect evidence from the highest-ranking sources available for your device and clinical claims.
Consulting an Expert for PMCF
If you are not sure what PMCF activities may be necessary for your device, we recommend consulting with an expert. Determining the right PMCF strategy requires deep knowledge of regulatory requirements, clinical evidence standards, and your specific device characteristics.
Expert Support Available
Eclevar has a team of experts who can support you in developing a comprehensive PMCF strategy tailored to your device, therapeutic area, and regulatory pathway. Our experts can help you identify data gaps, select appropriate PMCF activities, and prepare documentation that meets Notified Body expectations.
Key Takeaways
- PMCF is mandatory under EU MDR unless you can justify that no PMCF is needed
- EU MDR requires continuous post-market clinical follow-up throughout the product lifetime
- Class III and Class IIb implantable devices require annual PMCF reports
- For other device classes, PMCF is required if insufficient clinical evidence exists for all indications and target populations
- Pre-market clinical trials alone are insufficient to demonstrate safety and performance throughout a device's lifetime
- PMCF is a continuous process of updating clinical evaluation as defined in EU MDR 2017/745: Annex XIV, Part B
- Device failures under MDD led to stricter PMCF requirements under MDR
- PMCF is critical for maintaining CE certification and market access in the EU
- Failure to provide adequate PMCF plans and reports risks loss of CE certificate
- PMCF applies to both MDD-to-MDR transitions and new MDR submissions
- Notified Bodies expect PMCF plans to address all data gaps identified in the CER
- PMCF activities depend on device risk classification, data deficiency level, and market duration
- Notified Bodies do not prescribe specific PMCF activities; manufacturers must justify their choices
- State-of-the-Art (SOTA) evaluation must inform clinical claims parameters and acceptance thresholds
- PMCF survey options include prospective surveys, registries, and clinical studies
- Clinical evidence hierarchy ranks interventional studies (Rank 1-2) highest, followed by registries (Rank 3) and surveys (Rank 4-8)
- High-quality surveys rank higher than general surveys in the evidence hierarchy
- Emerging risks discovered post-market must be addressed through updated PMCF activities
- Real-life settings provide evidence that controlled pre-market trials cannot replicate
- Expert consultation is recommended for developing an effective PMCF strategy
Need Expert Guidance on PMCF Strategy?
Our team of regulatory and clinical experts is ready to help you develop a PMCF strategy that meets Notified Body expectations and supports your regulatory success.
Schedule Your Free ConsultationGet in Touch
If you have questions about PMCF requirements or need support developing your PMCF strategy, please feel free to contact us at clientcare@eclevar.com. Our team is ready to support your regulatory pathway.