This post discusses how medical device manufacturers can cut costs when dealing with PMCF activities under EU MDR law and introduces our PMCF cost calculator.
What is PMCF and why does it matter in the EU MDR era?
According to the EU MDR (Medical Device Regulation) which comes into effect in May 2021, PMCF (Post-Market Clinical Follow-up) is a continuous process that updates the clinical evaluation referred to in Article 61 and Part A of the regulation’s Annex. It is part of proactive PMS (Post-Market Surveillance) and identifies and investigates residual risks associated with medical devices that are on the market and serves to update the clinical evaluation in a lifecycle approach. Therefore, it plays a pivotal role of ongoing medical device regulatory compliance in the European Union. Under MEDDEV 2.12-2, it was only mandatory for higher risk classes, but with the EU MDR, it has become compulsory for all device risk classes. It can sometimes require medical device manufacturers to conduct additional clinical investigations, called PMCF studies.
Some of the key ways in which PMCF can create value for MedTech have been put together in this blog post.
What types of PMCF are there?
PMCF can be managed as:
- A clinical study
- A registry
- A customer or product user survey
- Feedback from key opinion leaders,
- A follow-up with patients
It is necessary to adapt each type of PMCF specifically to each device which can sometimes be challenging for manufacturers.
Survey Results: EU MDR is a costly matter
Our recently published survey results revealed that the EU MDR will cost many manufacturers more than 5% of their annual revenue. More than half are investing over five hours per week in managing the new demand and two thirds are hiring at least one new employeeAt the same time, relatively few companies were tapping into the potential of digital or cloud-based solutions for their clinical data capture, with just 11% having implemented an Electronic Data Capture (EDC) system like Climedo, while more than two thirds relied on Excel spreadsheets and nearly half worked with paper-based solutions. With data collection in the post-market phase being such a crucial part of the EU MDR, we believe that such manual systems are likely to struggle in the near future. Not only do they prevent MedTech companies from retrieving specific data quickly and in a targeted manner, they are also more error prone, since the data needs to be gathered and evaluated manually.
Discover the PMCF cost calculator
Due to this significant gap between high costs caused by the regulation on the one hand, and a relative lack of digitization within the surveyed companies on the other hand, we decided to crunch some numbers with our team and developed a simple yet powerful PMCF cost calculator for MedTech companies. Our aim is to help manufacturers work out exactly how much they could be saving per PMCF study and year if they were to use an EDC solution as opposed to paper or Excel sheets.
How we built it
The typical costs of the PMCF example study cited in the Whitepaper were calculated based on intensive research, interviews with industry experts and our own empirical values. The calculator subtracts the cost of a typical Climedo study from a compilation of different example studies which are conducted using paper or Excel to show the potential savings for MedTech companies if they were to opt for a digital solution. Two example calculations cited in the Whitepaper portray how companies conducting small studies can save nearly 10% in their annual PMCF study costs while companies working on larger studies can even achieve up to 50% in cost savings.
If you’re interested in taking a look at the cost calculator, you’re welcome to give it a try based on your individual assumptions and study criteria for your internal cost-benefit calculation. Simply reach out to us to get a tailor-made version of your very own calculator and see how you could be saving valuable costs right away!
And if you want to learn more about Climedo’s EDC solutions in light of the EU MDR, drop us a line or sign up for a free trial!