On May 5, 2017 the new Medical Devices and IVD Regulations have finally been published on the Official Journal of the European Union.
The new Regulations will enter into force on May 25, 2017.
A three years transition period for Medical Devices and a five years one for IVDs will follow.
As already mentioned in the previous articles (EUROPE: The European Parliament approves the new Medical Devices and IVD Regulations ), the new Regulations replace Directives 93/42/EEC (Medical Devices), 90/385/EEC (active implantable devices) and 89/79/EC (IVDs).
For more information: