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In brief

In October 2021, the Medical Device Coordination Group (MDCG) published the third revision of the MDCG 2019-6 Questions and answers: Requirements relating to notified bodies, which provides clarification on the operating procedures of notified bodies responsible for performing conformity assessment activities under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.


In particular, the update concerns the section dedicated to services offered by notified bodies in the phases preceding the start of the actual certification process and clarifies that said services, such as the review of clinical data and the assessment of the quality management system, can be carried out only after the manufacturer of the device has submitted a formal application for evaluation, without which the performance of these services would be considered as a consultancy.

In this regard, however, the MDCG specified that this prohibition does not apply to general training activities relating to the regulation of devices or to standards and that are not client specific, provided that the content is not customized, that the training does not involve exclusively the concerned manufacturer and that it does not take place at the latter’s premises.

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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