19.05.2023
To the attention of manufacturers, authorised representatives, economic operators and all stakeholders
Please be advised that on 12 May 2023, the European Commission published the revision of document MDCG 2020-3 with guidance on the significant changes to the transitional provision in Article 120 of the MDR relating to devices covered by certificates, in line with the MDD or the AIMDD.
The changes made are as follows:
Section 4.1 – General provisions:
• Minor text change to clarify the fact that the changes made in order to comply with other Union legislation fall within the scope of the guidance only if the risk/benefit balance of the device is not adversely affected.
• Minor text change and introduction of a footnote regarding the validity of certificates during the transition period.
• Introduction of a footnote regarding statements listing insignificant changes for Class I devices.
Section 4.2 – Changes unrelated to design or intended purpose:
• Introduction of a footnote to rule out changing the legal manufacturer in the first example provided.
• Introduction of a final statement regarding the notification procedure agreed between the manufacturer and the notified body.
In section 4.3.2.3 – Design changes:
• Improved text in examples related to changes brought to device case and user interface layout, for more clarity.
• Inclusion of a note on the Benefit/Risk balance (in bold) in each subsection, for better reading and understanding.
The European Commission notification can be accessed at: https://health.ec.europa.eu/latest-updates/update-mdcg-2020-3-rev1-guidance-significant-changes-regarding-transitional-provision-under-article-2023-05-12_en
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