The article provides an overview of the new rules for placing surgical masks on the market published by the Italian Ministry of Healthcare.
The Italian Ministry of Healthcare announced the new procedure for placing surgical masks on the country’s market. The announcement published on the authority’s website states that due to the changes in the overall situation related to the COVID-19 outbreak, it was decided to change the procedure of placing new surgical masks on the market. In particular, starting from April 1, 2022, the masks should be placed on the market under the general procedure for this type of medical device instead of a special regime introduced temporarily during the period when surgical masks were vitally important and the demand was huge. It is further explained that the products already placed on the market could remain available until May 31, 2022, and should be used by healthcare professionals directly involved in withstanding the virus.
The authority announced the adoption of a circular dated March 4, 2022, which prescribes the new approach to be applied to surgical masks intended to be marketed and used in Italy. The document prescribes the procedure to be applied when the state of emergency is no longer in force. Moreover, the document reminds medical device manufacturers that starting from May 26, 2021, the Directive 93/42/EEC is no longer applicable, so it is necessary to ensure compliance with the respective regulatory requirements set forth by the Regulation (EU) 2017/745 (Medical Device Regulation or MDR).
The new regulation is intended to change the regulatory framework set forth by the decree dated March 17, 2020, by the virtue of which a simplified and accelerated procedure for placing surgical masks on the market has been implemented to ensure the uninterrupted availability of these products during the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the “novel coronavirus”. In particular, the said special regime was initially intended to remain applicable till the end of the emergency state.
The new regulation also establishes requirements regarding the technical documentation to be submitted by medical device manufacturers when applying for marketing approval. In particular, it is stated that the scope of information to be provided in this documentation should be sufficient to evaluate compliance with the applicable safety and performance requirements the products of this type should meet. The authority additionally emphasizes the importance of presenting all the information in a clear and understandable format. The statements should be accompanied by the proper evidence justifying them based on the tests conducted, including the details about the testing methods applied. The requirements to be applied concerning design, manufacturing, and testing of surgical masks are set forth by the applicable international standard EN 14683:2019 “Facial masks for medical use – Requirements and test methods”. However, it is important to mention that the requirements set forth therein are currently not harmonized with the requirements prescribed by the Regulation.
The authority also highlights the most important aspects to be considered by medical devices manufacturers. The aspects specially addressed in the circular include, inter alia, the following ones:
- All the tests should be performed using final devices, while all the tests conducted using fabric itself should not be considered as a substitution for testing the device;
- Irrespectively of the regulatory framework initially applied, the manufacturer should duly obtain a certificate confirming compliance with the applicable safety and performance requirements;
- The manufacturer can use technical documentation as a basis for the declaration of conformity, which is acceptable for Class I medical devices and could be used to justify the affixing of the CE marking.
Quality Management System
The new document pays special attention to the requirements related to the Quality Management System (QMS) to be duly developed and implemented by the medical device manufacturer to ensure continuous compliance with the applicable requirements at all the steps of the manufacturing process.
The authority reminds us that currently the new EU-wide database for medical devices, EUDAMED, is not fully operational. Hence, the initial registration procedure should still be applied.
The scope of the announcement published by the Ministry of Healthcare also covers the aspects related to the obligations of medical device manufacturers after the products have been placed on the market. In this regard, the authority states that medical device manufacturers are responsible for developing and implementing an efficient system of post-market surveillance necessary to ensure the safety and proper performance of medical devices within the whole period of them being placed on the market.
Hence, the products that are fully compliant with the regulatory requirements described hereinabove could be placed on the market and supplied to customers in Italy, provided the above mentioned procedures are duly followed by their manufacturers.
In summary, the new circular adopted in Italy describes the way the procedures for placing surgical masks on the market should be switched back from a special temporary regime to the ordinary framework existing before the pandemic. At the same time, the new approach also reflects the changes introduced due to the new regulation entering into force – the Regulation 2017/745 (MDR), which has replaced the Directive regulating the same matters before.
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