Introduction
A public consultation was opened last week about the first implementing act related to the Medical Devices and IVD EU Regulations. The act concerns the Notified Body (NB) product codes used to categorize the fields of expertise of the NBs and thereby define their scope.
This system will cover a multi-dimensional typology of devices (represented by each code) to ensure that a designated NB is competent to handle the devices they are required to assess.
The codes are laid out in two Annexes, one for Medical Devices and the second for IVDs. As an example, the code MDA 0101 will represent Active implantable devices, while the code IVS 1001 will recognize Devices intended to be used for near-patient testing.
Implications
After the public consultation phase, the publication is expected on 26th November 2017. From that moment on, the Bodies will be able to appoint for the designation, related to the codes/ device types they will assess, that will most probably lead to a final audit from the EU Commission.
Do you need a Notified Body?
If you would you like more information on the CE Certification processes, please don’t hesitate to contact us! Obelis will be delighted to assist you thanks to our 30 years of expertise in the field of European Compliance for Medical Devices and IVDs.
In addition, a specific service, the Notified Body Selection, is designed and offered to our clients in order to find the most appropriate and suitable Notified Body to assess and certify their device.
Davide Turchi