No CE Marking Required for Surgical Masks and Personal Protective Equipment

In the wake of the COVID-19 pandemic, the Italian Government lifted regulatory requirements for the manufacturing, importing and placement on the market of surgical masks and other personal protective equipment.

The measures were prompted by a failure of existing manufacturers and importers to meet the demands of hospitals, healthcare professionals and individual citizens alike, and are seen as generally in line with the Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat (https://eur-lex.europa.eu/legal-content/GA/TXT/?uri=CELEX:32020H0403).

The new emergency regulations (law decree 18/2020 – http://www.governo.it/it/articolo/decreto-legge-17-marzo-2020/14333) provide that manufacturers, importers and other businesses who intend to commercialize surgical masks and personal protective equipment, are required to submit a self-certification to the National Health Institute (“Istituto Superiore di Sanità” – https://www.iss.it/) or to the National Workers Insurance Agency (“INAIL”) respectively, whereby they describe the technical specifications of the devices/equipment and declare that the devices/equipment meet the safety requirements set forth in applicable legislation. The competent authorities are then required issue a compliance decision within 3 days from the submission.

The technical procedures for the submission to the authorities have now also been implemented and, with reference to surgical masks, they require an additional certification from the applicants concerning the compliance of the devices with quality standards UNI EN 14683:2019 and UNI EN ISO 10993-1:2010. A quality system should also be implemented, but such system does not need to be certified: the implementation of adequate procedures and traceability measures would be sufficient to meet the applicable requirements.

While certain regulatory requirements are meant to remain place in order to ensure the reliability of products placed on the market, the authorities are hopeful that the new emergency measures will provide relief to hospitals and healthcare operators operating under the current extraordinary circumstances.

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