The European Commission published an updated Medical Device Coordination Group (MDCG) 2020-3 Rev.1 – Guidance on significant changes regarding the transitional provision under Article 120 of the MDR in May 2023. Changes were made throughout the guidance document to align it with Regulation (EU) 2023/607 (updates to MDR/IVDR transitional provisions) and with the similar guidance document for IVDs, MDCG 2022-6.
The transitional provision under Article 120 of the MDR allows devices that were placed on the market or put into service under the Medical Device Directive (MDD) or Active Implantable Medical Devices Directive( AIMDD) to continue to be placed on the market or put into service under the MDR until 27 May 2025. The legacy devices cannot undergo any significant change in the design or intended purpose after the date of application of the MDR which is May 26, 2021, to benefit from the transition periods stipulated by Article 120(3) MDR.
Medical Device manufacturers should be aware of the following key elements as outlined in the guidance:
- If a manufacturer intends to place a device on the market that has been modified after the date of application of the MDR, they must first comply with all the requirements of the MDR. This includes obtaining a certificate from a notified body if the device is a Class IIa, Class IIb, or Class III device.
- If a manufacturer makes a significant change to a device covered by a certificate under the MDD or AIMDD, they must first notify the notified body that issued the certificate. The notified body will then assess the change to determine if it is significant. If the notified body determines that the change is significant, the manufacturer will need to obtain a new certificate from the notified body before they can place the modified device on the market.
- 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.
According to Article 120, a significant change to a medical device is any modification that could affect the device’s safety, performance, or intended use. Below are some examples of significant changes that may require a new certificate under the MDR:
- Changes in the device’s design, materials, or manufacturing processes that could affect its safety or performance.
- Modifications to the device’s intended purpose or indications for use.
- Changes to the device’s labeling or instructions for use.
- Alterations in the device’s software or firmware.
- Changes in the device’s sterilization method or packaging.
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