The Covid-19 medical emergency has led to the necessity to find Medical Devices and personal protective equipment (PPE). In response to this, with 17 March 2020 Law Decree no. 18 (articles 15 and 16), the Italian Government has specified different types of derogation procedures to allow the production of surgical masks and personal protective equipment.
The derogation to the ordinary certification procedure for Medical Devices only concerns the timeframe and not the product quality and technical standards.
The Italian National Institute of Health (ISS) has created the “COVID-19 Medical Devices work group” which is in charge of evaluating the use of medical masks without CE marking notwithstanding the ordinary certification procedure and only for this emergency period.
Furthermore, the ISS has published an updated document on PEE indications for use.
To produce surgical masks the companies must send to the ISS a self-certification in which they describe, under their own responsibility, the technical characteristics of the masks. The companies have to declare that the masks meet all safety requirements.
No later than 3 days after the self-certification, the manufacturers must send to the ISS any element that can be useful for the validation of the masks.
The masks must meet the following requirements:
- They must correspond to both UNI EN ISO 14683 and UNI EN ISO 10993 regulations;
- They must be produced by companies that have a Quality System
These requirements are also valid for the production of “non-woven fabric” masks.
To produce PPE items (including FFP2 and FFP3 masks) the manufacturers wanting to use the derogation, must send a self-certification to the Italian National Institute for Occupational Safety (INAIL). In this document, they must confirm, under their own responsibility, the technical characteristics of the abovementioned devices and declare that they meet all the safety requirements. In particular, FFP2 and FFP3 masks should be certified according to Law Decree no. 475/1992 and in compliance with UNI EN 149:2009 regulation.
Whenever, according to the ISS and/or INAIL evaluation, the products do not comply with the regulations, the Manufacturer must immediately stop their production and the Importer must not place them on the market.
There is no regulatory exemption for the importation of ventilators and IVD swabs: the CE marking must be affixed on the products, as usual, in compliance with the current directives.