The EU Medical Device Regulation, also known as EU MDR, refers to an updated list of regulations. Based on the Medical Device Directive (MDD), it would be operational from May 26, 2021. As per this new set of rules, medical device manufacturers have to get their finished items CE-marked.
If you are a medical device manufacturer eyeing the European market, you must comply with the EU MDR. So, where does post market clinical follow up (PMCF) fit in here? In case you don’t know, PMCF refers to the clinical experience data with your device after the market release.
These activities usually range from data analysis of existing devices to a new clinical investigation. Both American and European regulatory bodies recommend medical device manufacturers opt for PMCF. Also, note that the clinical data gathered in the pre-market stage is too limited. PMCF is crucial to recognize new and unknown factors of risk. Here are some of the goals of this new set of regulations.
- Improve the overall safety and reliability of the new medical devices
- Enhance strict market surveillance and vigilance
- Promote transparency and information among service users
What are the Post-Market Surveillance Requirements for the European Market?
Post-Market Surveillance or PMS is an integral component of increasing your reliability among medical professionals and end-users. Note that in the United States, you have to opt for PMS activities only for high-risk devices.
These high-risk medical or clinical devices usually need pre-market approval. On the contrary, things are a bit different in the European market. In the European market, irrespective of the medical device, it is compulsory to opt for PMCF.
And in case you fail to make your devices pass through the PMCF, you have to provide proper justifications. PMCF is a standard requirement in instances where your device utilizes novel medical technology. It is also a requirement where your product would be used among high rusk populations.
What are the PMS Requirements in the US Market?
In the US, wherever you want to sell your medical devices, you must comply with the standard requirements. To be precise, in the US, the FDA is the main regulatory body. FDA assists with the facilitation of the PMS with its MedWatch platform.
Note that this platform is a web-based portal. It permits the users of your medical device to report anomalies and adverse effects related to your device. Always remember that the FDA also executes its own PMS activities. It is necessary to opt for post-market clinical follow-up for these below-mentioned instances.
- For class 2 and class 3 devices that require implantation for more than one year
- For class 2 and class 3, devices that can have severe repercussions for human health if they fail
- For class 2 and class 3 devices that are of utmost importance to human life
- For class 2 and class 3 devices that have broad use in pediatrics
So as you can see, PMS is growing in relevance in the realm of international medical devices. So it is significant to comply with the PMCF requirements to increase the trust and viability of your brand.
What is a PMCF Plan?
The PMCF plan refers to the documented results that should be present in the final evaluation report. The PMCF plan carries information that has enormous significance for regulatory documents.
How to write a Detailed PMCF Plan?
- Details of usual methods to be applied
- The type of specific methods you need to implement
- Comply with the PMCF plan design and structure
Is PMCF required under MDD?
PMCF is typically required for all products. However, it may be justified not to present it during the clinical evaluation. This justification depends on the type of device, intended purpose, and a class of danger and should explain in a meaningful way why PMCF is not needed.