Qarad is glad to inform you that the new European Regulations for Medical Devices and IVDs have been published in the European Official Journal on May 5, 2017.
This publication represents the conclusion of a five-year legislative process but, at the same time, it’s the beginning of a new European regulatory regime which will have to be dealt with by manufacturers world-wide for the next 20/25 years as predicted by the European Commission.
The new EU regulatory framework will be much more demanding than the current directive-driven ones.
The most challenging areas will be in the field of Clinical Evidence, the Risk/Benefit ratio, the introduction of UDI and, for IVDs, a classification revolution which will bring almost all IVDs under the direct control of Notified Bodies.
Manufacturers of those (rather few products) falling into the MD-R Class 1 (non sterile, non measuring) and the IVD-R Class A will be able – if ready – to start CE marking their products under the Regulations regime starting from May 26th because the Regulations officially enter into force (= beginning of the transition period) 20 days after the publication.
However all manufacturers of products above the self-certification classes will have to wait from 6 to 12 months before they will be able to CE mark their products under the Regulations for the very simple reason that this is how long it will take for the Notified Bodies to file their applications and to have them reviewed and accepted by their respective Competent Authorities and other experts as per the joint assessment procedure requirements.
This is just the beginning of a long and complex path that all MD manufacturers will have to walk at a certain point in the next 3 years while IVD ones will have 5 years (duration of the transition period).
