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News and Views June 2017

News and Views May 2017 - Latest Update

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News and Views May 2017

Latest news: At the finalization of this current newsletter, important news was received that the MDR and IVDR will be published on May 5. Take this in consideration when calculating the timelines below. 

New Regulation (just approved!)

New Regulation
On April 5, 2017, after some five years of negotiations, the European Parliament has now approved the final versions of the Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR), allowing implementation efforts for these major new regulations to proceed.

You can find the final versions of the Regulations in the following links:
- Medical Device Regulation (MDR)
- In-vitro Diagnostics Regulation (IVDR)

It is the end of a long and enduring process, but it also marks the beginning of another long and resource-intensive implementation stage for Manufactures and Notified Bodies.

Some concerned voices say that the new regulations place unrealistic demands on the industry including the cost of certifications by a notified body.  The limitation of resources to fulfill the new regulatory demands could lead to significant delays for product approval in certain areas and subsequently the healthcare industry may lack the availability of important products.  In particular the short timeline for the MDR transition is considered very critical.

The majority, nevertheless, believes that this Regulation is a big progress towards increasing patients’ safety and will allow rebuilding trust between the public sector and the medical industry, by ensuring a greater surveillance as well as a balance between innovation and economic interests.

Here is a video from the European Parliament on the subject:

The dates you should be aware of:
  • Early May 2017 - The MDR and the IVDR will be published in the Official Journal of the EU.
  • Early June 2017 – 20 days following official publication, the Regulations will enter into force.
  • June 2020 - The MDR will become applicable in Europe.
  • June 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 June 2020 and all IVD by June 2022 (some exceptions may apply).

Seems like a lot of work? 
Well… it IS!! So let’s start preparing for it NOW

Your MDSS Team

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.