What happens to existing products after the transition period at the end of 2027 or 2028?

Legacy devices must, after the expiry of the transitional periods, in accordance with the requirements of the Medical Device Coordination Group (MDCG), either be fully compliant with the Medical Devices Regulation (Regulation (EU) 2017/745, MDR) or be withdrawn from the market.

The guidance document MDCG 2021-25 specifies the following steps:

MDR compliance required:

Manufacturers must subject legacy devices to an MDR conformity assessment procedure, including:

- Updated technical documentation in accordance with Annex II MDR

- Fulfilment of the General Safety and Performance Requirements (GSPR)

- Implementation of post-market surveillance (PMS) and post-market clinical follow-up (PMCF)

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Quality Management System (QMS)

Vigilance and registration

- Reporting of incidents during the transitional period and registration in EUDAMED

For which Class I products under the MDD does the transitional provision of the MDR require the involvement of a notified body for the first time?

All Class I products which were classified as Class I under the MDD but, according to the new classification rules of the MDR, are now assigned to a higher class. This particularly concerns:

- Class I sterile devices (Is)

- Class I products with measuring function (Im)

- Reusable surgical instruments (Ir)

When does which transitional period apply to legacy devices?

From 26 May 2024 (for most products) or 31 December 2028 (for high-risk Class III products and implantable Class IIb devices), legacy devices may no longer be placed on the market unless they have been successfully certified under the MDR.

Do existing products need clinical trials (clinical investigations) after the transition period?

Not all legacy devices necessarily require a new clinical investigation (within the meaning of a clinical study) for clinical evaluation under the MDR. The requirements depend on the available clinical evidence and the demonstration of safety and performance. Existing clinical data from the time of MDD/AIMDD certification as well as post-market data (e.g. from PMS, PMCF studies, literature) can continue to be used for legacy devices, provided they are sufficient and MDR-compliant.

When is a clinical investigation required for legacy devices or innovative medical devices?

MDCG guidance 2020-6 states that a gap analysis must be performed for legacy devices. If deficiencies exist, the manufacturer must address these specifically – for example, through supplementary literature data, PMCF studies or, if this is not sufficient, a new clinical investigation.

Many clinical evaluations have been based on so-called equivalence comparisons, i.e. data from a comparable device. However, if access to the complete data of the reference device cannot be ensured, or if these data themselves no longer meet the requirements of the MDR, or if the reference device is withdrawn from the market for other reasons, a clinical investigation of the manufacturer’s own device may be required. Regulations and examples can be found in MDCG guidance document 2023-7.

Furthermore, for products for which higher requirements arise due to MDR classification and the previous data are therefore insufficient, a clinical investigation may become necessary. Ultimately, new indications, expanded areas of application or significant changes to the device that are not substantiated by existing data will also necessitate a new clinical study.
If the clinical evaluation (according to Annex XIV MDR) reveals gaps that cannot be closed by literature, PMS or PMCF, a clinical investigation is mandatory.

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Would you like to know whether your data for legacy devices is sufficient? We are happy to support you with our experience. Please feel free to arrange an initial non-binding consultation with us. We're here for you!

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