The guidance document, 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 in accordance with Directive 98/79/EC”, which has been applicable since May 2022, provides recommendations for actions that make it easier to assess the application of the requirements of the IVDR to so-called “legacy devices”. The guide is also relevant to “old devices”.
Important definitions for IVD products during the transition phases
The term “legacy devices”, as defined in the second and third subparagraphs of Article 110(3) of the IVDR, subsumes devices that
- were placed on the market or put into service after 22 May 2022 and
- have not undergone any significant changes in design and intended purpose under the first subparagraph of Article 110(3) of the IVDR by the end of the relevant transition period
- and that
- either have an IVDD certificate issued by a notified body
- or for which a self-declaration of conformity was drawn up in accordance with the IVDD, but which require the involvement of a notified body in accordance with the IVDR
The group of “old devices” includes those in-vitro diagnostic devices that
- were placed on the market or put into service before 22 May 2022 in accordance with the requirements of the IVDD (Directive 98/79/EC) or equivalent national provisions, before the IVDD entered into force (i.e., before 27 October 1998)
and which are still on the market or in use after 26 May 2022.
The transition periods from IVDD to IVDR
An important aspect to consider is the respective transition periods, which are briefly outlined below:
- The transition period ending on 26 May 2025 applies to all products that
- hold a valid CE certificate issued in accordance with the requirements of the IVDD before 26 May 2022.
- are Class D devices (according to the specifications of the IVDR) with a declaration of conformity according to the IVDD, issued before 26 May 2022, which for the first time require the involvement of a notified body for conformity assessment
- The transition period ending on 26 May 2026 applies to the following products:
- Class C devices (according to the specifications of the IVDR) with a declaration of conformity according to the IVDD, issued before 26 May 2022, which for the first time require the involvement of a notified body for conformity assessment
- The transition period ending on 26 May 2027 applies to the following products:
- Class B and A sterile devices (according to the specifications of the IVDR) with a declaration of conformity according to the IVDD, issued before 26 May 2022, which for the first time require the involvement of a notified body for conformity assessment, the aforementioned transition period applies;
According to the adopted amending Regulation (EU) 2023/607, there are no longer any sales deadlines for compliant products. All IVDD-compliant in vitro diagnostics placed on the market by 26 May 2022, as well as all products that may still be placed on the market under 98/79/EC in accordance with the applicable dates, can be sold without a deadline. However, the product lifecycle / shelf life defined by the manufacturer must of course be observed.
Post-Market Surveillance under IVDR for legacy devices
Another point to be considered with regard to the requirements of the IVDR for legacy devices are the requirements for post-market surveillance, market surveillance and vigilance. Articles 78 and 79 of the IVDR must be observed (implementation of an adequate PMS system and establishment of a corresponding PMS plan), with the exception of the requirements of Article 78(3), point (d), of the IVDR.
The provisions of Annex XIII, Part B of the IVDR on “Post Market Performance Follow-Up” (PMPF), on the other hand, must also be completely applied to legacy devices, although the retrospective provision of a PMPF report is not required.
Likewise, Articles 82 to 84 related to vigilance and specifically the handling of reporting of serious incidents and field safety corrective actions (Article 82), trend reporting (Article 83) and analysis of serious incidents and field safety corrective actions (Article 84) are fully applicable to legacy devices.
Since the IVDD has not provided any specifications for the classification of IVD products, it is difficult to draw a line in terms of the subdivision of the reports to be prepared in the context of post-market surveillance for legacy devices; therefore, it was decided that for IVD legacy devices of all classes a PMS report according to Article 80 IVDR must be prepared as a minimum requirement, while the preparation of a periodic safety update report (PSUR) is not mandatory for manufacturers of IVD legacy devices of the risk classes C and D. The PSUR report must be prepared in accordance with Article 80 IVDR.
What else should be considered for legacy devices?
In principle, all requirements for “legacy devices” specified in connection with the conformity assessment procedure according to IVD Directive 98/79/EC must continue to be complied with, as well as the fact that no significant changes have occurred with regard to the design and intended purpose in order to be able to continue to carry the original CE marking. In addition to the aspects required by the IVDR, which go beyond the areas already mentioned, such as
Post-market surveillance (PMS),
Market surveillance and
Vigilance
the requirements for the registration of economic operators and products must also be met. Special reference should be made here to the extended obligations of economic operators, namely:
- Article 10 – General obligations of manufacturers
- Article 11 – Authorised representative
- Article 13 – General obligations of importers
- Article 14 – General obligations of distributors
IVDR requirements outside the above-mentioned subject areas are generally not applicable to economic operators with regard to “legacy devices”; a voluntary commitment, in particular if both “legacy devices” and IVDR products are in the portfolio, is of course permissible.
This is particularly interesting with regard to the Responsible Person according to Article 15. For example, the appointment of a responsible person is listed as not required in the Annex to MDCG 2022-8 for legacy devices. However, Article 94 (4) subparagraph 2 stipulates an administrative offence if a manufacturer, as defined by the IVDR, does not have a responsible person in place. Definitions could now be thrown into the ring and questions raised about the formerly applicable MPG (German Medical Device Act), but this constellation is quite theoretical, since most manufacturers will presumably continue to place a part of their portfolio on the market according to the IVDR in the future and thus have to appoint a PRRC anyway.
PMS and other obligations for old devices
A final note on dealing with the “old devices” described above:
In principle, the requirements of the IVDR are not to be applied and implemented for these devices. However, manufacturers of “old devices” must also carry out market surveillance, which must be followed up by the notified bodies. Articles 88 to 95 of the IVDR deal with the rights and obligations of notified bodies with regard to market surveillance. The focus here is on reporting and the analysis of serious incidents and safety corrective measures in the field in order to ensure safe use of “old devices” throughout the entire product lifecycle and to identify non-compliant products in due time (Articles 82 and 84 of the IVDR).
MDCG Guidance on Legacy Devices
A (non-exhaustive) list of the most important requirements of the IVDR and their respective application or non-application for “legacy devices” can be found in the annex of the MDCG guidance document. For example, the requirements for the UDI are not applicable.
In the practical implementation of the requirements of the IVDR and related to these recommendations, this annex is strongly recommended for manufacturers of “legacy devices”. seleon GmbH is happy to support you in the evaluation of your established medical devices and their clinical data. So that the tried and trusted also has a place in the future.
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.
