The EU Medical Device Regulation (EU MDR) is a new and updated set of regulations, following on from the Medical Device Directive (MDD), that will now come into force on May 26, 2021. It requires medical device manufacturers to take prime responsibility for getting their products CE-marked in order to sell in the European marketplace and is much stricter than the previous directive, especially in terms of risk classes and the oversight provided by notified bodies (NBs).
There is also more emphasis on a life-cycle approach to safety, backed up by clinical data and post-market monitoring. This will require manufacturers to not only reactively assess the safety and performance of their devices, but they will also need to proactively assess and record this data throughout the product’s lifecycle.
EU MDR's Post-Market Clinical Follow-up (PMCF)
“The Medical Device Regulation (EU) 2017/745 (MDR) considers the post-market clinical follow-up (PMCF) as a continuous process that updates the clinical evaluation and that shall be addressed in the manufacturer’s post-market surveillance (PMS) plan,” according to the Medical Device Coordination Group in "Post-market clinical follow-up (PMCF) Plan Template."
In simple terms, PMCF falls within the Post-Market Surveillance (PMS) plan and will outline how the manufacturer will proactively collect and evaluate the clinical data from of their CE-marked medical device. The aims being described by the MDCG as:
- Confirm the safety and performance, including the clinical benefit if applicable, of the device throughout its expected lifetime.
- Identify previously unknown side-effects and monitor the identified side-effects and contraindications.
- Identify and analyse emergent risks on the basis of factual evidence.
- Ensuring the continued acceptability of the benefit-risk ratio.
- Identifying possible systematic misuse or off-label use of the device, with a view to verify that the intended purpose is correct.
PMCF via End-User Surveys
There are multiple options and strategies to consider when compiling the evidence for PMCF, with the main approaches being randomized clinical trials (RCTs), registry studies, retrospective patient record reviews, literature reviews, end-user surveys, and focus groups.
When weighing which approach(es) to take, it is vital that the balance between the level of evidence required and the time and effort to collect this evidence is considered. While RCTs and registries provide a higher level of evidence, they are often time consuming and expensive; end-user surveys, on the other hand, provide slightly lesser evidence but are much lower effort, cost-effective and have a much quicker turnaround.
The justification for end-user surveys will depend on the type of medical device, including the risk classification and previous data obtained. They can be used alongside other PMCF methods to strengthen the evidence of data for all risk classes, however, it would be recommended to perform a registry or study for any Class II/III devices without any previous clinical data.
How to implement PMCF End-User Surveys
Purdie Pascoe has worked with several of the leading medical device manufacturers over the last couple of years to help them prepare their MDR submissions, aiding them with both the design and the execution of the surveys themselves. Some of the key things that medical device manufacturers need to consider, and provide information on, in order to run an end-user survey include:
- Device type – name, therapy area & risk classification.
- End-user information – speciality type and screening criteria (e.g., usage thresholds).
- Usage/sales information – unit sales broken down by region and country.
- Sample size requirements/feasibility – dependent on the type of device and sales volumes.
- Safety information – adverse events/complications that can be taken from the IFU and/or CER and used in the survey.
- Performance attributes – any performance claims that can be used for testing within the survey.
Once this information has been provided, the survey itself can be designed, programmed, translated, and launched to relevant end-users. The results and data can then be analyzed and interpreted before being delivered in a format that can help aid your PMCF and PMS MDR submissions.
Finally, why it is important to start thinking about this now . . .
As a manufacturer you will have to comply with the EU-MDR by May 2021, and if not, some of your much-needed medical devices may be forced to come off the European market. The earlier you begin that transition the better, particularly due to the:
- High number of devices on the market.
- Shortage of Notified Bodies.
- Anticipated bottleneck in reviews by Notified Bodies.
- Ongoing need to interpret certain provisions of the Regulations.
- Additional resource burden (cost and time).
So make sure that you have everything in place to be compliant with the EU-MDR, today.