The final text of the two new IVD and MD Regulations is already published. Have you started planning your transition?
On 5th of April 2017, the European Parliament approved the Regulation of In-vitro Diagnostic Products and Medical Devices. Once it has been published, it will come into force after 20 days. It is expected to enter into force in June 2017.
The new standards will apply 3 years after publication for sanitary products and 5 years for in vitro medical products.
Read more about it in the next links: