Purdie Pascoe leads the way on EU MDR Compliance

The date is set! Will you be EU MDR compliant by the 26th May 2020?

This is the date by which the EU’s Medical Device Regulations (EU MDR) will require manufacturers to adhere to new, stricter regulations to ensure that their devices are safe to use and allow them to be sold across Europe.

The key change is the requirement for Post-Market Clinical Follow-Up (PMCF) data. In the future, manufacturers will be required 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. These new regulations will be enforced by quality organisations such as BSI and TUV.

Every PMCF must be carefully planned and tailored to each specific medical device (dependent on device classification). While this may be a challenge for manufacturers, understanding the correct approach is essential.

Ways to implement your PMCF activities:

• Literature reviews

• Focus groups

• User feedback during training

• Customer/user surveys (Purdie Pascoe offering)

• Device tracking/implant registries

• Complaint handling

How can Purdie Pascoe help?

At Purdie Pascoe, we have already designed and implemented more than 40 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. 

So, if you are ready to implement your PMCF plan, or you’re simply not sure where to start with the new EU MDR regulations, get in touch with us. We can help support in the design of the PMCF plan and the design and facilitation of the surveys themselves. Let us help you become EU MDR compliant!

For more information, please contact Marcus Torr, Head of PMCF, at marcus.torr@purdiepascoe.com