Don’t miss the MDR transition deadline for your borderline device

“Thank God I can use my MDD substance based device until 2028!”

This is a sentence we often hear, but many manufacturers are not aware that this is subject to certain conditions:

  • An application for a conformity assessment procedure should be submitted to a Notified Body by 26 May 2024

  • A contract for a conformity assessment procedure with a notified body must be concluded by 26 September 2024

Only then can the product continue to be placed on the market until 31 December 2028.

So, if you are an affected manufacturer what should you do next?

Transitioning your substance-based devices (rule 21) or device drug combination products (rule 14) to MDR can be particularly complex.

Exploiting our close contacts to notified bodies and decades of expertise as a service provider for both pharmaceuticals and devices, we have successfully navigated MDR borderline challenges for clients.

Therefore, we can support you to meet the MDR transition deadline by:

  • Connecting to a suitable notified body with sufficient resources

  • Lodging your formal MDR application before 26 May

  • Providing sufficient evidence to pass a Notified Bodies pre-application assessment of device qualification and risk classification

  • Updating your TD including CTD compilation for ancillary medicinal substances

  • Managing your conformity assessment and consultation procedure with a competent authority

  • Taking over legal manufacturer responsibility to speed up your MDR certification

Find out how we can help

Talk to one of our experts today and find out how we can help you meet the MDR transition deadline
and keep your MDD borderline device on the market.

Tom Wood
Thomas Wood
Regulatory Manager (Medical Devices)
BOOK A MEETING WITH TOM
Tom Wood
Latest posts by Tom Wood (see all)