Recently, two new guidelines, MDCG 2022-5 and MDCG 2022-6, were published on the website of the European Commission and approved by the Medical Devices Coordination Group (MDCG). The guidelines are drafted in collaboration with interested parties represented in the various groups and are not legally binding. They present a common understanding of how the MDR and IVDR should be applied in practice aiming at an effective and harmonised implementation of the legislation.
MDCG Guideline 2022-5 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices (MDR) was issued on 26 April 2022. This guideline was established by Article 103 of MDR. It provides further explanations and examples clarifying provisions laid down in the MDR and Directive 2001/83/EC relating to medicinal products for human use (MPD) in order to support the uniform application of the MDR across the EU. The document starts with the general discussion of the borderline between medical devices and medicinal products, including relevant definitions and examples. Separate chapters are dedicated to herbal products, substance-based devices, and medical device/medicinal product combinations.
MDCG Guideline 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR was issued on 4 May 2022. This document explains the concept of ‘significant changes in the design and intended purpose’ under IVDR Article 110(3). It concerns manufacturers of devices that are compliant with Directive 98/79/EC (IVDD) and that are placed on the market or put into service after 26 May 2022 during the transition period in accordance with Article 110(3) IVDR, irrespective of whether or not those devices required notified body involvement under the IVDD.
The conditions for the application of the transitional provisions in Article 110(3) IVDR are that the devices continue to comply with the IVDD and that there are no significant changes in the design or intended purpose of the device after the date of application of the IVDR. Therefore, it is important for manufacturers and notified bodies to have a clear understanding as to what changes to design or intended purpose would be considered ‘significant’ under Article 110(3) IVDR.
The annex to the document contains a chards of design changes and changes of the intended purpose which may be considered ‘significant’ when interpreting the first sentence of IVDR Art. 110(3).
Do you need additional knowledge or assistance in meeting the requirements of MDR/IVDR?