06.10.2023
To the attention of manufacturers, authorised representatives, economic operators and all interested parties
Please be informed that on 27 September 2023, the European Commission published the new version of the document Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
New products such as endovascular adhesives, sensors, irrigation solutions, customised implants and many more have been introduced.
The European Commission notification is available at: https://health.ec.europa.eu/latest-updates/manual-borderline-and-classification-community-regulatory-framework-medical-devices-september-2023-2023-09-27_en
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