The long-awaited European Medical Device Regulations were published in May 2017. Regulation 2017/745 for medical devices and 2017/746 for IVDs represent a complete overhaul of the current Directives and most medical device manufacturers will be affected in some way by the changes.

Main changes include:

• More complex conformity assessment processes, including increased requirements for Notified Bodies
• More stringent requirements for clinical data. Equivalence will be much more difficult to demonstrate.
• Changes in the definition of a medical device – some aesthetic devices will now be included.
• New requirements for a “person responsible for regulatory compliance”.
• Unique Device Identification (UDI) and requirements for public access databases for traceability purposes.
• Increased responsibilities for Authorised Representatives.
• New classification rules for software, nano materials, human and animal tissue and some other devices.

We have until May 2020 to comply with the MD regulation and May 2022 for the IVD regulation. That may seem like a long time, but it will be here before we know it!

Most Notified Bodies are only just making their applications for designation, so it could be some time before anyone is in a position to offer certification against the new regulations. It’s never too soon to start preparing though, so get in touch if you want to start your own assessment of the impact of the MDRs.