New Maetrics whitepaper outlines critical components of the European Medical Device Regulation for Class I manufacturers and the fall-out derived from non-compliance
Maetrics, a leading international life sciences regulatory and compliance consultancy, has launched a new whitepaper highlighting the critical importance for Class I medical device manufacturers to comply with the EU Medical Device Regulation (MDR). The MDR transition period ends on May 26th 2020 at which point any non-compliant manufacturers will be restricted from selling and distributing their products on the EU market.
This new whitepaper has been created to serve as a valuable tool for Class I medical device manufacturers to help ensure they maintain EU market access. The aim of the whitepaper is to raise awareness of the pressing issue of dealing with reclassification and achieving timely compliance under the MDR, providing guidance and practical steps that Class I manufacturers should take as soon as possible.
The key points Maetrics highlights in this whitepaper are:
• The MDR contains new stringent rules on classification, causing many current Class I devices to be up-classified.
• More Class I products will require Notified Body review to comply with the Regulation and have the appropriate certificates for CE Marking.
• Only devices which were CE marked under the authority of a Notified Body through the MDD will have a grace period until up to May 2024 to continue selling their devices in Europe.
• Any Class I device which was previously self-certified and now needs Notified Body review must have a new MDR-compliant CE Mark by 26th May 2020.
Any manufacturer unaware their products are being up-classified risks not having the appropriate post market and clinical data to submit to their Notified Body in order to ensure certification under the MDR by the deadline. Not to mention, a delay in tackling MDR conformance could result in further delays due to increasing Notified Body capacity issues, as the Commission scrambles to re-designate the Notified Bodies under the MDR.
The full whitepaper is available to download here.
