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In brief

In April 2021, the Medical Devices Coordination Group published a new guidance to explain the role of safety and performance standards under the current Medical Device Directives, as well as the new Medical Device Regulation and the In Vitro Diagnostic Devices Regulation.

Firstly, the guidance confirms the voluntary nature of the use of harmonized standards in the context of product conformity assessment procedures. Indeed, the guidance clarifies that a manufacturer may always choose to apply the technical solutions provided by harmonized European standards, non-harmonized European standards, or by any other international or national standard, or even to develop its own technical solutions, provided that it is able to demonstrate that these different non-harmonized standards are suitable to prove compliance with the legal requirements applicable to the product.

Moreover, the document provides additional important clarifications by specifying that products designed and manufactured according to applicable harmonized European standards whose references are listed in the Official Journal of the European Union (OJEU) benefit from a presumption of conformity with relevant legal requirements. Conversely, if the manufacturer uses a different standard, such as the most recent version of a harmonized standard, whose references are not listed in the OJEU, then the manufacturer must provide further safety and effectiveness pieces of evidence within the technical documentation in order to ensure compliance with applicable legal requirements.


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.


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

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