Search for:

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 has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.

Author

Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

Write A Comment