EU MDR – while working from home, get ahead of the game

Now is not the time to sit back and relax.

Earlier this month the EU commission announced that the date of application of the new Medical Devices Regulation (MDR) will be postponed by one year, to 26th May 2021, in order to allow members to prioritise the fight against coronavirus.

The good news is that this gives you, and the rest of the medical devices industry, one additional year to ensure compliance with the EU MDR requirements. We, at Purdie Pascoe, have been working with several leading global manufacturers for the last couple of years to help them get ready for the original deadline. If you haven’t already got your house in order, we can help you start assessing and preparing now in order to be ready for May 2021.

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 proactively assess and record safety and performance throughout a product’s lifecycle, and one way of doing so is to conduct customer surveys.

We can help support in the design of the PMCF plan and the design and facilitation 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 report

At Purdie Pascoe, we have already designed and implemented more than 45 bespoke PMCF user surveys for some of the leading medical device companies. 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!

For more information, please contact Marcus Torr, Head of PMCF, at marcus.torr@purdiepascoe.com or if you have colleagues who are working on EU MDR compliance, please forward this information to them today.