On August 10th, 2022, the Medical Device Coordination Group (MDCG) released a new guidance document. This document aims to provide guidance to the authorities responsible for notified bodies and joint assessment teams (JATs) when conducting a) assessments of conformity assessment bodies (CABs) that apply for designation of notified bodies (NB) in the field of medical devices and/ or in vitro diagnostic medical devices and b) re-assessment of NBs (MDCG 2022-13).
This guidance is intended for use by Designating Authorities and Joint Assessment Teams to assist them when conducting assessments of Conformity Assessment Bodies applying for designation as NB or when reassessing NB.
This document, outlines actions to improve the efficiency of the implementation of regulatory requirements to avoid disruption of supply of IVD and MD. Actions are proposed to address 3 major challenges: increasing NB capacity, improving access to NB, and improving manufacturer preparedness.
For class D devices, Article 48(6) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) establishes the conditions to be applied by the notified body to determine whether it has to consult the expert panel on the performance evaluation report of the manufacturer.
These conditions are:
(1) the absence of common specifications for the class D device in question, AND
(2) where it is also the first certification for that type of device.
This revision provides further clarification on the meaning of ‘the first certification for that type of device’ and on the corresponding procedures to be followed by the notified body.s
What does this mean to you?
MDCG 2022-13 can be used as a reference to see how Notified Bodies are designated.
MDCG 2022-14 is of interest for all IVD manufacturers. The propositions from this guidance do not solve the capacity issues or access to the notified bodies. Do not wait till the end of the transition phase, start your certification under the IVDR now.
MDCG 2021-22 Rev1 provides you with further clarification on the definition of what is to be considered “the first certification for that type of device”. If you manufacture a class D device this is detrimental in the decision if an expert panel is to be involved or not in the assessment of the device’s performance evaluation report.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
