Notified Bodies intention to submit designation application MDR and/or IVDR
By Davide Turchi – RA/QA Consultant
Without any doubts, Notified Bodies are a particular type of entity that is highly affected by the new Medical Devices and In-Vitro Diagnostics Regulations. Notified Bodies will be strictly assessed and audited by the European Commission and National Competent Authorities in order to receive accreditation to certify medical devices under the New Regulations.
Notified Bodies are requested to send a designation application which will initiate a review process that might lead to a Designation/Confirmation under the Medical Device Regulations.
Declaration of Intent
Despite the great challenge that lies ahead, it was recently reported the first intention to submit designation application MDR and/or IVDR from the Notified Bodies which are members of the Notified Bodies Association – TEAM NB. This may serve as a good indication, mainly to medical device Manufacturers, concerned about any possible interruption of their CE Certification.The list of Notified Bodies presenting the intention to be audited can be downloaded here: Team-NB-MDR-IVDR-Application.
Do you need a Notified Body?
It is important to remember that there are still about 34 other NB’s which are not members of TEAM-NB that may present their applications as well – so it is still difficult to know which Notified Bodies will remain.Taking into account all these coming challenges, Obelis offers a specific service for Notified Body Selection – this service is designed and offered to manufacturers wishing to find a suitable Notified Body for their devices.
Please do not hesitate to contact us to know more about how we can help you locate a Notified Bodies.