In this article, we discuss the importance of PMCF activities required by EU MDR as part of Post Market Surveillance. EU MDR requires medtech manufacturers to update clinical performance and safety of their devices periodically throughout their product lifetime. Unless sufficient clinical evidence is provided that support the product’s clinical performance and safety covering the entire product lifetime, this PMCF report is required every year for high-risk medical devices such as Class III and Class IIb implantable devices. For other class devices, PMCF is required if clinical evidence has been established to demonstrate clinical performance and safety for all indications and target populations throughout the products’ lifetime.
Although the PMCF was mentioned in the MDD, there was not emphasized nor clearly stated as to a mandatory element. Now, under MDR, the PMCF is mandatory unless you can justify that no PMCF is needed for your product.
Why the PMCF is mandatory under EU MDR?
Regulatory Background
Because of many device failures leading to serious adverse events under the MDD, 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 just pre-market clinical trials or studies would not provide sufficient evidence for clinical safety and performance in real-life situation throughout lifetime. Thus, MDR defines Post-Market Clinical Follow-Up (PMCF) is 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, the PMCF is needed when there is not sufficient clinical evidence to support all clinical claims.
The Importance of PMCF for CE Certification
The PMCF is therefore required to collect data to fill any data gaps in the CER. If your CER does not provide sufficient clinical data to support your clinical claims, the PMCF is the pathway to establish sufficient clinical evidence. If you fail to provide the PMCF plan and the PMCF report with evidence intended to be generated, you would risk to lose your CE certificate. Thus, the PMCF is critical for your business in the EU market. This applies to both the transition from MDD to MDR and afterwards.
As mentioned earlier, because of a number of device failures leading to serious incidents, European Commission legislated the medical device regulation that put the highest priority on clinical safety and performance of medical devices that are marketed in the EU market knowing that 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, the PMCF has been set as means to establish such evidence and update risks and benefits when any emerging risks are found in the due course.
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 NB, what type of PMCF activities are needed depend upon the risk classification of your device, the level of data deficiency and the length of time the product has been in the market. If you are in the process of transitioning from MDD to MDR, you must have already the PMCF Plan along with the CER. You may receive deficiency feedback from the NB with regards to clinical evidence for your clinical claims. The NB does not instruct you what PMCF activity to fill those gaps and therefore, if you receive such data deficiency feedback from the NB, you should review not only data that are missing but also clinical claims that have been set and their parameters, and then literature search protocol that has been set. In some cases, not sufficient clinical evaluation is conducted based upon 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, then, you will need to collect those data through the PMCF unless you can prove safety and performance of your product on the particular claim without conducting the PMCF.
Types of PMCF Activities
As for types of PMCF activities, there are several options depending what evidence level is required and feasibility of the activity such as:
PMCF surveys
Registries
PMCF studies (either prospective or retrospective)
For the hierarchy of clinical evidence, The high quality survey is rank 4 and the general survey is rank 8. The registries are rank 3, the interventional clinical studies are either rank 1 or 2 depending of their study design (please see MDCG 2020/6 Guidance for Sufficient Clinical Evidence, Appendix III).
Consulting an Expert for PMCF
If you are not sure what PMCF activities may be necessary for your device, we recommend to consult with an expert. Eclevar has a team of expert who can support you on this. If you need support, please be free to contact us at: clientcare@eclevar.com.
