The MDR has been on the regulatory horizon for a long time, with draft versions published in 2016 and the final version in May 2017. 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. 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.
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.