EU MDR – Will you be ready in 11 months’ time?
The clock is ticking...
When the date of application of the new Medical Devices Regulation (MDR) was postponed by one year, you may have taken a huge sigh of relief. The extra year meant that you could relax, focus on the more urgent tasks, and put your EU-MDR work off for a while.
Eleven months is not long, though. At Purdie Pascoe, we have been working with several leading global manufacturers for the last two years to help them get ready for the original deadline. If you do not yet have everything in place to ensure that you are compliant, you really need to start your preparations now or risk being non-compliant come May 2021.
Non-compliance could mean losing regulatory approval to market your medical devices in Europe. The earlier you begin your transition to the new processes needed to be compliant, 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) on your organisation
How can Purdie Pascoe help?
The Purdie Pascoe team can assist manufacturers as their device enters the post market surveillance (PMS) phase, and more specifically with the implementation of the post market clinical follow-up (PMCF) plan. There is a requirement to pro-actively assess and record a device’s safety and performance once on the market.
There are various 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.
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 sufficient evidence and require less work, money and time.
We can help support in the design, facilitation, and execution of the surveys themselves. Our services include:
Determination of the appropriate approach, sample size and usage thresholds
Development of the survey materials
Programming, testing and hosting of the online survey (in all local languages)
Compensation of participants
Fieldwork management, coordination and quality control
Data processing
Analysis and interpretation of results
Deliverables of raw data and a full PowerPoint/PDF report
Since the start of 2019, we have already designed and implemented 50+ bespoke PMCF user surveys for several of the leading medical device manufacturers. Our approach is compliant with the new EU MDR regulations and has been approved by several of the leading notified bodies (including BSI and TUV). Let us help you become EU MDR compliant!
Helpful information
The MDCG has released new guidance for post-market clinical follow-up (PMCF) requirements, providing guidance templates for the PMCF plan and the PMCF evaluation report:
PMCF Plan Template: https://ec.europa.eu/docsroom/documents/40905
PMCF Report Template: https://ec.europa.eu/docsroom/documents/40906
For more information, please contact Marcus Torr, Head of PMCF, at marcus.torr@purdiepascoe.com
