On 12 May 2023, the revision to MDCG 2020-3 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 was published, which integrates the process of managing significant changes for legacy Medical Devices to bring it in line with Regulation 2023/607.
The most important changes concern the definition of intended use and the design for identifying the significance of the change. With regard to the intended use, changes that entail a decrease or elimination of certain indications for use or certain areas of application such as anatomical sites or methods of use are not considered significant. Instead, changes that are an extension of the intended use or an addition of certain indications for use, possible users and/or possible clinical applications of the product are considered significant.
With regard to design, changes to the operating principle, power source and alarm system are not considered significant provided they do not adversely affect the safety, performance or usability of the device. Specifically, changing the size or shape of an alarm button is not significant, nor changing the battery or modifying a battery in a rechargeable system.
Conversely, the elimination or addition of an alarm system and the modification of the measurement functions of a device are considered significant.
The guidance also gives examples of non-significant changes relating to product specifications and labelling. With regard to product specifications, the following are not considered significant changes: changing the colour of the device and changing features that have already been certified, for example a new stent of intermediate length among the lengths already subject to CE certification. With regard to labelling, changes aimed at improving end-user understanding of certain warnings or critical information are not considered significant.
Furthermore, the new revision establishes that certificates issued according to MDD cannot be modified or replaced, but may be supplemented by an act of the Notified Body indicating the change that has taken place and the reasons why it is not to be considered significant according to Art. 120 MDR.
In conclusion, the new revision of the guideline facilitates the interpretation and practical application of paragraph 3 of Article 120 of the MDR (EU) 2017/745. In general, compared to the previous version, it is more schematic, contains many examples and presents in an annex a series of Flow Charts which, thanks to their sequential blocks, allow one to arrive at a suitable interpretative solution independently.
>>>Do you want to know more about it? Thema can help you in implementing the requirements of Regulation 2023/607 to benefit from the extension and the MDR (EU) 2017/745 Medical Device Regulation, thanks to its strategic-regulatory consulting services, CE certification support and, if necessary, European authorised representative.
Contact us for more info.
Source:
