MDCG 2022-8 Application of IVDR requirements to legacy devices
Regulation (EU) 2022/1121 extended the transitional provisions of the IVDR Regulation (EU) 2017/746 on in vitro diagnostic Medical Devices (IVDs) by amending the provisions in terms of scope and timing in Article 110(3).
While all non-sterile class A devices must comply with IVDR (EU) 2017/746 as of last 26 May 2022, the fully effective regime is different for devices belonging to other risk classes. For these latter, a transition period of varying lengths will persist. In particular:
- For higher risk devices (class D) the requirements apply from 26 May 2025;
- For class C devices, the application date is 26 May 2026;
- For sterile class B and class A devices, the requirements apply from 26 May 2027.
The guideline now provides guidance on the applicability of IVDR (EU) 2017/746 requirements to legacy devices, i.e. benefiting from the transitional period.
In particular, they are defined as ‘legacy’ devices in the IVD field:
- devices covered by a valid EC certificate issued by a notified body under Directive 98/79/EC on in vitro diagnostic Medical Devices (IVDD) before 26 May 2022;
- devices for which a declaration of conformity was drawn up before 26 May 2022 under the IVDD and for which the conformity assessment procedure under the IVDR (as opposed to the IVDD) requires the involvement of a notified body.
Pursuant to the fourth subparagraph of Article 110(3) of IVDR (EU) 2017/746, the requirements on post-market surveillance, market surveillance and vigilance apply to legacy devices.
This means that MVDD manufacturers must implement and maintain a post-market surveillance system (PMS) based on process procedures, PMS plans and reports (Articles 78 and 79 IVDR), and trend analysis, enable product and process control of MVDD devices by Competent Authorities or dedicated Notified Bodies, and implement an appropriate adverse event reporting system. Requirements related to the obligations of economic operators and Eudamed are also to be applied, thus already in force as of 26 May 2022.
MDCG 2022-9 Safety and Performance Summary Template (SSP)
Article 29 of Regulation (EU) 2017/746 on in vitro diagnostic Medical Devices (IVDRs) requires the manufacturer to prepare a Safety and Performance Summary (SSP) for class C and D devices, which are not intended for performance studies. The SSP must be validated by a Notified Body (NB) and made available by the manufacturer through publication in the European Eudamed Database. The SSP includes user and, where relevant, patient information and must always be kept up-to-date in Eudamed.
Apart from the case of a self-diagnostic device, the SSP must be written in a clear and comprehensible manner for all, and structured with the features indicated in the guideline, and in particular includes:
- a first part dedicated to the professional user;
- if relevant, an additional second part dedicated to the patient.
For self-diagnostic devices, the SSP must be clearly written for patients/laypersons, considering the distinctive characteristics of the target group, such as age.
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Sources:
Medical Devices Medical Device Coordination Group Document MDCG 2022-8
Medical Devices Medical Device Coordination Group Document MDCG 2022-9
