Due to the new Medical Devices and In-Vitro Diagnostics Regulations, Notified Bodies will have new responsibilities meaning that they must obtain accreditation to certify medical devices under the New Regulations. To do so, Notified Bodies are requested to send a designation application to the Competent Authorities and will then be assessed and audited by the European Commission and National Competent Authorities.
In October 2017 Team NB published that all its 24 members had the intention to submit their application to be designated for MDR while just half of them had the intention to apply for IVDR, with an overall scope (which is a total of 36 applications). At that time, no information was known regarding the position of the other almost 34 Notified Bodies which are not members of Team NB.
This October, the European Commission published the state-of-play of joint assessments of Notified Bodies in the medical device sector stating that they have received a total of 33 applications (26 under MDR and 7 under IVDR), meaning that in the last 4 months, only five more applications have been submitted. They have also received 22 Preliminary Assessment Reports from the “designating authority” (17 MDR and 5 IVDR).
Regarding on-the-spot assessments, the European Commission has carried out 11 Joint Assessments in the last 5 months and has 11 more scheduled between October and January 2019. Only 2 JAT opinions are under preparation and it is expected that notified bodies will obtain MDR designation in July 2019.
It is important to bear in mind that there is no information on the applications received by national designating authorities and that other notified bodies can still present their applications – which makes it difficult to know which Notified Bodies will remain.
Taking into account all these coming challenges, Obelis offers a specific service for Notified Body Selection – assisting manufacturers to find a suitable Notified Body for their devices.
Additionally – thanks to our CE Extension Request service – help to obtain a CE certificate extension of six months (for those manufacturers whose Notified Body does not apply for the new Regulations), providing thereof a smooth process transition between the changes of Notified Bodies.
Please do not hesitate to contact us to learn more about how we can help you locate a Notified Body.
Claudia Miralles