MDCG updates: July – September 2022

Guidance NoAbout the guidance
MDCG 2021-22 Rev.1Clarification 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

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 guidance provides clarification on the meaning of these conditions and on the corresponding procedures to be followed by the notified body.
MDCG 2022-15Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR (September 2022)

Article 110(2) and 110(3) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) state that devices which are covered by valid certificates issued by a notified body under the Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) may be placed on the market1 or put into service2 after the date of application of the IVDR and no later than 26 May 2025 under certain conditions.

The above mentioned conditions require that the notified body that issued the certificate under the IVDD continues carrying out appropriate surveillance in respect of the applicable requirements relating to the devices it has certified. Therefore, it is important for manufacturers, notified bodies and national authorities to get clarity on activities to be part of the appropriate surveillance referred to in Article 110(3) of the IVDR.

To appropriately address application of transitional provisions to devices covered by certificates according to IVDD, this guidance, drafted in line with MDCG 2022-4 on appropriate surveillance under the MDR3 and MDCG 2022-8 on application of IVDR requirements to ‘legacy devices’4, should be read in conjunction with guidance MDCG 2022-6 on significant changes.

For the purpose of this document, ‘legacy devices’ should be understood as devices which, in accordance with Article 110(3) of the IVDR, are placed on the market after the IVDR date of application (26 May 2022) and until the end of the respective transition period set out in the 2nd or 3rd subparagraph of Article 110(3) if certain conditions are fulfilled6. In this guidance only devices covered by a valid EC certificate issued in accordance with the IVDD prior to 26 May 2022 are addressed.
MDCG 2022 – 14MDCG Position Paper – Transition to the MDR and IVDR Notified body capacity and availability of medical devices and IVDs

In this position paper, the MDCG lists actions to enhance notified body capacity, access to notified bodies and manufacturers’ preparedness in order to facilitate transition to the MDR and IVDR and to avoid shortage of medical devices. The MDCG will implement and/or support the implementation of the actions listed in a timely manner, assess the progress and the impact of those actions, and assess whether further actions are needed. To this end, the MDCG counts also on the full commitment of all actors involved, including notified bodies and industry, to implement the actions and provide the data necessary for the
monitoring of the market by the MDCG.

Even though the above mentioned challenges are currently more pressing in the area of the MDR, most of the actions listed in this document also apply in the area of the IVDR. Supporting the transition to the MDR and IVDR is a continuous process, which may require adding actions to those listed in this position paper.
MDCG 2022-13Designation, re-assessment and notification of conformity assessment bodies and notified bodies

This document aims to provide guidance to the authorities responsible for notified bodies (hereafter, the Designating Authorities) and joint assessment teams (JATs) when conducting:
i) assessments of conformity assessments bodies (CABs) that apply for designation as a notified body (NB) in the field of medical devices and/or in vitro diagnostic medical devices, and
ii) re-assessments of NBs.
Additionally, this guide is intended to bring consistency and to align the working practices of the different designating authorities in the Member States, regarding the assessment, designation, notification and re-assessment of CABs and NBs.
MDCG 2022-12Guidance on harmonised administrative practices and alternative
technical solutions until Eudamed is fully functional (for Regulation
(EU) 2017/746 on in vitro diagnostic medical devices)

This document provides guidance to Member States and other relevant parties on the application of certain IVDR provisions during the absence of Eudamed. To that end, this guidance intends to describe harmonised administrative practices and alternative technical solutions for the exchange of information until Eudamed becomes fully functional.

The proposed practices and solutions aim to enable Member States and other relevant parties to meet their obligations under the IVDR effectively while minimising any potential additional burden on the parties concerned. This guidance addresses in particular cases where the exchange of information would be difficult, or even not possible, to achieve based on the corresponding provisions of Directive 98/79/EC. The proposed practices and solutions set out in this document do not affect the general obligations of the parties to comply with the applicable requirements under the IVDR.