Mdr in vitro

Notified Bodies re-design under new MD/In Vitro Diagnostics Regulation

26th November 2017 is the deadline for application

26th November 2017 is the deadline for application
November 14, 2017

Since the publication on March 5th 2017 of the New Regulations affecting Medical Device (MD) and In Vitro Diagnostics (IVD), a period of changes and challenges has started for the MD and IVD Industry.

The date of full application for Medical Device Regulation is 26th of March 2020, whereas IVD industry has two years more to adapt to the change. Many companies have started preparing in order to fulfil the new requirements included in the Regulations. The transitional period will be crucial for many companies to take important decisions in order to maintain their products on the market.

Although companies are starting to prepare for the change, success will not only depend on themselves. Notified Bodies will have to re-designate under the new Regulations that have increased requirements and more stringent criteria. Re-designation will suppose an effort that will demand Notified Bodies to put more resources and personnel at work for that purpose. November 26th this year is the deadline application for Notified bodies to re-designate. According to the European Association for Medical Devices of Notified Bodies, 84% of Notified Bodies intend to submit their application.

Over the next year, the first Notified Body re-designation is expected; therefore, as part of the MD industry, it is important to know if your Notified Body has intention to re-designate and whether this will be under the same scope. For the IVD industry, it should be noted that a lower number of Notified Bodies intend to apply for re-designation and that many IVDs that were self-certified will require to be re-certified under the new regulations with involvement of a Notified Body.

Thus, a few key questions to ask yourself could be: Have you started preparing for the new Regulations? Have you already contacted you current Notified Body? Is your Notified body re-certifying under the same scope?

If you need our support at any of the above highlighted issues do not hesitate to contact us at

Search News & Events

  • Filter by category


Related news and events

Christmas season greatings

Season’s Greetings

We wish you Happy ‘Xmas, Prosperous New Year and Health for you and your loved ones.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting