Does my medical device need a PMCF system for MDR compliance?
Post-Market Clinical Follow-up (PMCF) has assumed greater importance under the EU MDR than ever before. PMCF calls for the ongoing collection of safety and performance data throughout the commercial lifetime of a medical device, generating evidence on real-life experience with the product.
Understandably, some manufacturers are unclear whether a PMCF system needs to be implemented for their device and may prefer not to develop one unless absolutely necessary. This is particularly the case for legacy products with existing data, or with low-risk devices for which development of a bespoke PMCF system may at first glance seem unnecessary.
However, exceptions to the requirements for dedicated PMCF systems under the EU MDR are limited. It’s vital that all relevant device characteristics are considered in detail before forming conclusions.
Rapid PMCF Checker
The good news is that we have made the decision-making process easy for you. We have just launched our unique online PMCF Checker. Answer ten simple yes/no questions in a few minutes and our PMCF Checker will show you whether or not your device requires a dedicated PMCF system according to the rules in the EU MDR. Try it out:
Keeping medical devices in market / maintaining CE-marks
The 4 golden rules to drive regulatory compliance with PMCF and vigilance data collection.
How PMCF goes beyond simple compliance
The wider benefits of a well-designed PMCF system include improving your products and your relationship with your clients.
Why you'll almost certainly need a PMCF system for your medical devices
We tell you what to be aware of under the EU MDR regarding PMCF and your medical devices.
Increasing data entry compliance in PMCF studies
5 methods every medical device manufacturer should know to improve their Post-Market Clinical Follow-up studies.
Why medical doctors can drive MDR compliance
Working with the MDR requires knowing how to work with clinical evidence. Medical doctors are perfectly positioned to meet this requirement.
Ensuring that clinical investigations work in practice
How can medical device manufacturers ensure valid clinical investigations when access to medical expertise remains limited?
Out of the woods? EU regulators may delay MDR enforcement
A delay of the MDR would be welcome news for many, but what would a delay mean in practice? To what extent can preparations for EU MDR be put on ice?
The new MDR compliance challenge
Across the industry, medical device companies are facing challenges in meeting the demands of the new Medical Device Regulations (MDR) 2017/745 framework.
Sources of Real World Evidence for MDR compliance
At Mantra Systems our objective is to make sure that our clients choose the method of real world data harvesting that is right for them.