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In brief

On 17 May 2021, the Medical Device Coordination Group (MDCG) issued a notice addressed to manufacturers of in vitro diagnostic medical devices, and their authorized representatives, emphasizing the importance of continually assessing the impact of newly identified SARS-CoV-2 virus variants on the capability of those devices to ensure the safety of patients, compliance with essential requirements, a high level of performance, and overall compliance with applicable regulations.

What’s New 

The MDCG warned that the emergence of genetic variants of SARS-CoV-2 poses additional risks for in vitro diagnostic medical devices intended to detect and/or quantify markers of SARS-CoV-2 infection, including antibodies, which may not achieve the performance claims specified in the instructions for use, thus compromising the safety of patients, healthcare professionals or other individuals where a SARS-CoV-2 infection goes undetected. To this end, the MDCG urged manufacturers to review the risks associated with the use of devices on an ongoing basis to ensure that these are acceptable when weighed against the benefits to patients.

Lastly, the MDCG reiterated that it is the manufacturer’s responsibility to report any incident involving their devices to the relevant competent Authority and to inform end-users of any changes in the performance of devices which could result in direct or indirect harm to patients’ health.


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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