A revised MDCG guidance document has been released, MDCG 2021-22 Rev.1 – Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746.
According to Article 48(6) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices, the notified body shall consult the relevant experts referred to in Article 106 of Regulation (EU) 2017/745 on the performance evaluation report of the manufacturer when the conditions below apply:
- the absence of common specifications for the class D device in question, AND
- where it is also the first certification for that type of device.
This guidance document provides clarification on these conditions and on the corresponding procedures to be followed by the notified body.
This document also clarifies the definition of “first certification for that type of device”, which should be understood as the first certification under either Directive 98/79/EC or under Regulation (EU) 2017/746 by any notified body in relation to a product with a specific:
- intended purpose.
- analysis technology and process used.
If a device with a specific set of elements listed above:
- has been certified under Directive 98/79/EC, or
- is subject to an ongoing consultation of the expert panel under Article 48(6) of Regulation (EU) 2017/746, or
- has undergone a consultation of the expert panel under Article 48(6) of Regulation (EU) 2017/746, with the views published,
then notified bodies should consider any other device to be certified for the first time under Regulation (EU) 2017/746 with a similar set of elements as the same “type of device” irrespective of the manufacturer and therefore such devices will not need to be subject to a consultation with the expert panel.
To review a copy of this guidance document pleas follow this link: MDCG 2021-22 Rev.1
