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News and Views May 2017 - Latest Update


New Regulation (just published!)
Milestones


 
New Regulation
And it is official! The final versions of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) were published on the Official Journal of the European Union on May 05th!


You can find the publication of the Regulations in the following links: 

Milestones
The dates you should be aware of: 
  • May 05th, 2017 - The MDR and the IVDR have been published in the Official Journal of the EU.
  • May 26th, 2017 – After 20 days following the official publication, the Regulations will enter into force.
  • May 26th, 2020 - The MDR will become applicable in Europe.
  • May 26th, 2022 - The IVDR will become applicable in Europe.

During the transition period, the manufacturers must implement the regulations’ requirements in order to be able to continue placing products on the European market.  This means that all MD products must fully comply with the new regulation by May 26th, 2020 and all IVDs by May 26th, 2022 (some exceptions may apply). 
  
So... let’s get started!


Your MDSS Team


Disclaimer:  
This information is of a general nature only and not intended to address the specific circumstances of any particular individual or entity. Therefore, always refer to the applicable law when applying the regulation. 
All information contain in this Newsletter was provided from reliable and official sources of the European Union. However, MDSS cannot be held liable and asks the reader to verify any of the above, if being used to make decision concerning the products and business strategy. If you need specific advice, you should always consult a suitably qualified professional.