The European Commission’s Implementing Regulation concerning the list of codes defining the scope of designation of notified bodies under the Medical Devices Regulation (“MDR”) and In Vitro Diagnostic Regulation (“IVDR”) has been published in the Official Journal of the European Union.
Background
The MDR and IVDR entered into force on 26 May 2017. Both Regulations provided that the European Commission should by 26 November 2017, by means of implementing acts, draw up a list of codes and corresponding types of device. The purpose of the list is specification of the scope of the designation of notified bodies.
The purpose of the codes is to categorise the fields of expertise of the notified bodies and thereby designate their scope. Notified bodies are now able to express their intention concerning the designation they plan to request on the basis of this list of codes.
The published list of codes for designation under the MDR does not vary widely compared to those in the public consultation version published on 27 September 2017. One small but significant difference is that Code 1002 concerns devices manufactured utilising tissues or cells of human origin while Code 1002 of the draft version made reference to devices manufactured using tissues or cells of animal origin. Code 1003 of the final official version relates to devices manufactured using tissues or cells of animal origin.
There are significantly more changes for designation of notified bodies under the IVDR. The draft list from 27 September 2017 and the official published list vary substantially. About 20 codes have been removed from the draft version and several editorial changes have been made. In particular, Section 4 “In vitro diagnostic devices which require specific knowledge in laboratory and clinical disciplines for the purpose of product verification” has changed coding.
When notified bodies submit their application forms, available on NBOG’s website, they are required to list the scope of their planned activities by choosing the relevant codes.
However, it is unlikely that notified bodies will be designated under the MDR and IVDR in the near future. NBOG’s Best Practice Guide on the designation and notification of conformity assessment bodies suggested that the first notified bodies to apply for designation will have a final decision in about 20 months, July 2019 at earliest.
Medical devices manufacturers will be required to wait and see which notified bodies will be designated and the scope of their related activities.