On May 20th, 2022, the Medical Device Coordination Group (MDCG) released three new guidance documents. A Q&A on the Unique Device Identification system under MDR and IVDR (MDCG 2022-7), a guidance regarding the application of IVDR requirements to “legacy devices” and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC (MDCG 2022-8) and a Summary of Safety and Performance (SSP) Template (MDCG 2022-9).
MDCG 2022-7 – Q&A on the Unique Device Identification system under Regulation (EU) 2017/746.
This document provides the reader with several questions and answers that aim to provide further detail to operators on the application and practical implementation of the UDI requirements under the MDR and IVDR.
MDCG 2022-8 – Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022.
This guidance addresses the applicability of IVDR requirements to “legacy devices” and “old” devices.
Legacy devices have been defined as devices referred to in the 2nd or 3rd subparagraph of Article 110(3) of the IVDR, which are placed on the market or put into service after 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 the conditions laid down in the 1st subparagraph of Article 110(3)3 are fulfilled. Those devices can be:
a) devices covered by a valid EC certificate issued by a notified body in accordance with Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) prior to 26 May 2022; or
b) devices for which a declaration of conformity was drawn up prior to 26 May 2022 in accordance with the IVDD and for which the conformity assessment procedure
pursuant to the IVDR (contrary to the IVDD) requires the involvement of a notified body.
Old devices have been defined as those devices that were placed on the market or put into service before 26 May 2022 in accordance with the IVDD or the applicable national rules before the IVDD had become applicable and which are still on the market or in use after 26 May 2022.
Through this guidance the MDCG clarifies that the IVDR requirements in terms of post-market surveillance, market surveillance, and vigilance apply to legacy devices. The guidance states clearly that manufacturers of “legacy devices” need to set up a post-market surveillance (PMS) system based on a PMS plan (Articles 78, 79 IVDR) with the exception of aspects related to pre-market requirements, which are not applicable to “legacy devices”, such as to update the summary of safety and performance (Article 78(3), point (d), IVDR). This means that as part of the manufacturer’s PMS system, the post-market performance follow-up (PMPF) requirements (Annex XIII, Part B, IVDR) also apply to “legacy devices”.
In addition, also other IVDR requirements should apply to “legacy devices”, provided that those requirements relate to post-market surveillance, market surveillance, vigilance, registration of
economic operators and devices. IVDR requirements that are not related to these topics should in principle not apply to economic operators in respect to “legacy devices”. However, the market surveillance activity requirements of the IVDR do apply to “old” devices.
MDCG 2022-9 – Summary of safety and performance template.
According to Article 29 of the IVDR, manufacturers of Class C and D devices must draw up a Summary of Safety and Performance (SSP). This guidance documents provides manufacturers with two templates, one for devices intended to be used by professional users and one for devices intended to be used by lay persons (self-testing devices).
If the device is not intended for self-testing, the SSP should have a first part dedicated to the professional user. When relevant, a second part dedicated to patients/lay persons should be added. It should be written in a way that is clear to lay persons.
If the device is intended for self-testing, the SSP should be written in a way that is clear to the patients/lay persons, for instance taking into consideration the age of the targeted population.
The SSP shall be validated by the notified body and made available to the public via EUDAMED.
What does this mean to you?
MDCG 2022-7 is an interesting source when you are facing questions with regards to the UDI system under the MDR and IVDR. It clarifies some of the most frequent questions posed. It is an interesting read if some elements of the UDI are not yet clear to you or for your specific device.
MDCG 2022-8 is an invaluable guidance for all manufacturers of IVD legacy devices as it sheds light on which elements of the IVDR will apply to legacy devices as of 26 May 2022. Ensure you read this guidance carefully to fully understand what is to be expected of you as a manufacturer, but also of the economic operators within the supply chain.
MDCG 2022-9 offers all Class C and D manufacturers of a template to draw up their Summaries of Safety and Performance. We highly advice that you build your templates based on those provided within this guidance.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
