MDCG Guidance 2022-8
Regulation (EU) 2022/1121 extended the transitional provisions of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), in particular its Article 110(3), in terms of scope and timing. Following the approach set out in the report of the MDCG ad hoc task-force on transitional provisions of Regulation (EU) 2017/745 on medical devices (MDR) published as MDCG 2021-252 , the present document provides guidance as regards the applicability of IVDR requirements to ‘legacy devices’ and ‘old’ devices.
This Guidance sets out the Application of IVDR requirements to legacy devices
- Application of requirements set out in Chapter VII of the IVDR on postmarket surveillance, market surveillance and vigilance to ‘legacy devices’
In accordance with the 4 th subparagraph of Article 110(3) IVDR, the relevant requirements set out in Chapter VII of the IVDR on post-market surveillance, market surveillance and vigilance apply to ‘legacy devices’. That means 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.
As part of the manufacturer’s post-market surveillance system, the post-market performance follow-up (PMPF) requirements should apply to ‘legacy devices’. PMPF further develops the requirement in Annex III, section 5, of the IVDD6 . That means that, under the IVDR, manufacturers need to “proactively collect and evaluate performance and relevant scientific data from the use of a device”. However, this does not mean that the manufacturer would have to draw up, retrospectively, a performance evaluation report in line with the IVDR as performance evaluation and its documentation according to the IVDR is a pre-market requirement not applicable to ‘legacy devices’. The requirements and procedures related to serious incidents and field safety corrective actions and trend reporting as well as market surveillance provisions apply to ‘legacy devices’.
Regarding ‘legacy devices’ covered by certificates issued under the IVDD the notified bodies that issued the respective certificates conduct the ‘appropriate surveillance’ which essentially is a continuation of the previous surveillance activities under the IVDD.
- Application of other IVDR requirements to ‘legacy devices’
In addition to the requirements set out in Chapter VII IVDR, also other IVDR requirements should apply to ‘legacy devices’, provided that those requirements relate to post-market surveillance, market surveillance, vigilance or registration of economic operators and devices.
At the same time it extends the application of the IVDR to those requirements that support a well functioning vigilance and market surveillance system as well as proper registration of economic operators and devices.
Firstly, the general obligations of manufacturers and importers to place only devices on the market that are in conformity with the IVDR (Articles 10(1) and 13(1) IVDR) apply, whereas for ‘legacy devices’ conformity with the IVDR means conformity with the IVDD and the additional requirements in accordance with Article 110(3) IVDR. In addition, the obligations of economic operators set out in the following provisions should also apply to economic operators with respect to ‘legacy devices’.
- Application of IVDR requirements to devices placed on the market prior to 26 May 2022 (‘old’ devices)
IVDR requirements are in principle not applicable to ‘old’ devices. However, IVDR provisions should generally apply if they do not directly impact the device, its documentation or the conditions for the placing or making available of devices on the market. That means that Articles 88 to 95 IVDR, which lay down rights and obligations of competent authorities with regard to market surveillance activities, apply also to ‘old’ devices after 26 May 2022.
This allows competent authorities to check that those devices are in conformity with the rules applicable at the moment when they were placed on the market and to take appropriate measures against non-compliant or unsafe devices. Moreover, the reporting and analysis of serious incidents and field safety corrective actions occurring after 26 May 2022 in respect of ‘old’ devices should be done in accordance with Article 82 and 84 IVDR.
While this update is edited for easier interpretation for the manufacturers, we strongly recommend contacting our experts for further clarification and guidance.
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