New MDCG Guidance documents released (May 2023)

On May 12th, 2023, the Medical Device Coordination Group (MDCG) released the first revision on the guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD. (MDCG 2020-03 Revision 1).

MDCG 2020-03 Rev. 1 – Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD. (MDCG 2020-03 Revision 1).

The first revision of this guidance document MDCG 2020-3 on significant changes regarding the transitional provisions under Article 120(3) MDR takes into account the experience gained with the application of the original version so far, is aligned with the equivalent guidance for IVDs (MDCG 2022-6) and adjusted to Regulation (EU) 2023/607 amending Regulation (EU) 2017/745 (MDR).

It is intended to provide clarification on the concept of “significant changes in the design and intended purpose” under Article 120(3c), point (b) MDR. It concerns manufacturers of legacy devices.

All changes not having an impact on the design or the intended purpose of the device can be considered as not significant according to Article 120(3) of the MDR. Also changes in order to comply with other Union legislations are outside of scope even if they impact the design, but only if the risk/benefit ratio of the device is not negatively affected.

The manufacturer is responsible for providing evidence and justification that a change does not affect the design or intended purpose, or, in case the change affects design or intended purpose of the device, that it is non-significant, which should be assessed case-by-case. The outcome of the assessment should be documented and made available to a competent authority when requested. If a change is not a significant change in design or intended purpose, the implementation of such a change is allowed during the transitional period without the need for certification under the MDR. In such cases, the manufacturer is required to comply with the documentation requirements of the AIMDD/MDD, i.e. the updated technical documentation must allow assessment of the conformity of the product with the applicable requirements.

Administrative changes (changes concerning the manufacturers organisation) or changes concerning the manufacturing process should generally not be considered changes in the design or intended purpose within the meaning of Article 120(3c), point (b) MDR, even if they need to be reflected in the information to be supplied with the device (e.g. label or instructions for use).

Examples of such changes include:

• changes of the manufacturer’s name, address or legal form, including a merger or acquisition involving the manufacturer;
• changes in relation to the authorised representative;
  ….

Changes to the QMS are generally not considered to impact the design or the intended purpose, if the condition for which the conformity assessment was granted are maintained. In any case, changes continue to be subject to the agreed notification procedure between manufacturer and notified body.

On a final note, in the Annex of this guidance you will find 5 useful flowcharts to help you determine the significance of your change.