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In brief

In October 2021 the Medical Device Coordination Group (MDCG) published the Guidance on the classification of medical devices (“Guidance”). In particular, the purpose of the Guidance is to ensure the proper application of the classification rules set forth in Annex VIII to the Medical Device Regulation (EU) 2017/745 (MDR).


In addition to illustrating the purpose and practical relevance of the classification activity, the Guidance provides clarifications on the terms and notions used by the EU legislator both in the definitions provided for by Article 2 of the MDR and in the classification rules and principles, including “duration of use” and “invasiveness” as well as “active medical device”, “device with a measuring function” and “systems and procedure packs”. Moreover, by providing specific diagrams, the Guidance supports stakeholders in the application of the various classification rules for the purpose of identifying the correct risk class of the device

Lastly, the Guidance contains general explanations of the classification rules, including practical examples of devices matching the various definitions and risk classes, and addresses practical classification issues, where necessary, by providing clarifications on special concepts.

Author

Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.

Author

Riccardo Ovidi is an associate in Baker McKenzie's Rome office.

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