Legacy Devices: Guidance on significant changes according to the EU Medical Device Regulation (MDR) 2017/745
Article 120, paragraph 3, of the EU Medical Devices Regulation (MDR) 2017/745, amended by the latest Regulation (EU) 2023/607, states that devices that remain compliant with the AIMDD or MDD can be placed on the market until December 31, 2027, or December 31, 2028.
These devices are referred to as legacy devices, and according to the MDCG 2021-25 guidance on legacy devices, they are devices that, in accordance with the MDR’s transitional provisions, are placed on the market after the MDR’s application date (i.e., May 26, 2021) if certain conditions are met. Such devices may include:
Class I devices under Directive 93/42/EEC (MDD), for which a CE conformity declaration was drawn up before May 26, 2021, and for which the conformity assessment procedure under the MDR requires the involvement of a notified body.
Devices covered by a valid CE certificate issued under the Directive 90/385/EEC (AIMDD) or MDD before May 26, 2021.
The conditions are set out in Article 120, paragraph 3c, of the MDR and include, among other things, that legacy devices must continue to comply with the AIMDD/MDD5 where applicable, and that there are no significant changes in the device’s design or intended purpose. Therefore, it is important for manufacturers and notified bodies to have a clear understanding of what changes to the design or intended purpose would be considered “significant.”
On May 12, 2023, a revision to the MDCG 2020-3 guideline entitled “Guidance on Significant Changes regarding the Transitional Provision under Article 120 of the MDR for Devices Covered by Certificates under MDD or AIMDD” was published. This revision was necessary not only due to the extension of the validity of CE certificates under MDD and AIMDD according to the recent EU Regulation 2023/607 but also to improve and clarify some aspects that were somewhat unclear in the previous version.
The recent MDCG 2020-3 – rev. 1 provides a detailed explanation of which changes can be legitimately made to legacy devices, allowing the possibility of marketing them, and when such “changes” must instead be considered “significant,” thus eliminating the possibility of marketing.
The guide clarifies that a change to the devices is relevant for the purposes of Article 120 if it meets two requirements:
- The change must relate to the intended purpose and/or design (thus, different types of changes can be made while still applying Article 120 MDR).
- The change must be “significant” (the intended purpose and design do not affect the application of Article 120 MDR).
Various types of changes
Changes to the intended purpose:
The guide provides numerous examples of changes to the intended purpose of the product that can be considered significant and non-significant:
In evaluating whether the intended purpose has been modified, changes to the labeling or instructions for use, as well as promotional materials, which are related to the device’s intended use, should be taken into account (e.g., limitations, warnings).
The changes to the design
Regarding product specifications and labeling, the guideline provides some examples of non-significant changes:
- Change in the device’s color.
- Changes that fall within the range of already certified characteristics, for example, a new stent of intermediate length between the already CE certified lengths.
- Label changes to improve the user’s understanding of certain warnings or critical information.
- Changes to the external packaging.
Regarding a device component, changes such as modifying an electronic component due to obsolescence or changing the size or geometric shape of an alarm button are not significant. Regarding the power source, changing the type of batteries or modifying a battery in a rechargeable system is not significant.
Changes related to a substance or material
Changes related to sterilization
Guide to Modifying ‘Legacy’ Devices without Changing the CE Certificate
Since changes qualifying as “non-significant” can be legitimately made without “Legacy” devices losing their nature, Notified Bodies can (sometimes must) act on the CE certificate.
The certificate does not have to be changed. However, the notified body that issued the certificate according to AIMDD/MDD may confirm in writing, after reviewing the manufacturer’s description of the (proposed) change, that the implementation of the change does not represent a significant change in design or intended use within the meaning of Article 120(3c)(b) of the MDR and that the related AIMDD/MDD certificate remains valid until the end of the transition period.
Such written confirmation corrects or supplements the information on an existing certificate, but does not constitute the issuance of an “integrated certificate,” as this is prohibited as mentioned in Section 3.” Consequently, certificates in accordance with the MDD may not be amended or replaced, but may be “supplemented” through an act of the notified body indicating the change that has occurred and the reasons why it is to be considered “insignificant” under Article 120 of the MDR.
Therefore, the statement “the certificate in MDD cannot be touched” is only partially correct.
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