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 info@asphalion.com
