After some five years of working on the EU's new Medical Devices Regulation and IVD Regulation, the texts that were finally adopted on April 5, have been published in the Official Journal of the European Union.
This is a day that will go down in history for the medtech industry – the new EU Medical Devices Regulation and IVD Regulation have been published in the Official Journal of the European Union.
These are the texts that the whole EU sector must now work with and treat as their medtech holy book.
Today's event kickstarts the countdown to both new regulations taking effect in 20 days' time – on May 25.
It also marks the countdown to a series of other deadlines (details to follow).
Most importantly, it means that the MDR will become fully applicable as of May 25, 2020, and the IVDR as of May 25, 2022. These are the dates after which notified bodies will no longer be able to assess products against the EU medical device directives that the new regulations will replace.
Products CE marked under the medical devices and IVD directives, however, will be allowed to continue to circulate on the EU market after the full application of the regulations, although there will be limits for these.
It is also worth noting that there is a chance of some delays in setting up the necessary structures to support the full application of the MDR and IVDR, for example the new version of the Eudamed medical device database; but every effort is being made to have the database available on time.
Although the wording is unchanged, the final pdf version of the MDR is 175 pages long, compared with the 566 pages in the versions that have been previously circulated recently, and the IVDR is 157 pages long compared with 477 pages in recent previous versions.