The primary suppliers to the large medical device market in Italy are the United States, France, Germany, Belgium, and the Netherlands. High frequency medical lasers, home care equipment, remote monitoring equipment, anesthesiology equipment, stimulators, and defibrillators are in high demand.
The four classes of medical devices must comply with International Standard of Organization(ISO) 13485:2016.
Class I – not sterile, no measuring feature
Class IIa, IIb, III – sterile, with measuring function
The CE marking is the manufacturer’s declaration that the product meets European Union(EU) standards for health, safety, and environmental protection. Products with the CE mark, valid for five years, can be sold within the EU regardless of origin of manufacture. The manufacturer or his European Authorized Representative(EAR) sends notification and technical data to the Ministry to obtain the CE. All documentation must be in Italian, and forms for this purpose are available online. There is no charge for registering medical devices with the Italian Ministry of Health.
On 5 May 2020, the Ministry published clarification on authorization and procedures for Corona Virus Disease(COVID)-19-related medical devices. Applications (in Italian) to the Ministry are still required, although the conformity assessment procedure may not have been completed. Certain COVID-19 medical devices may be authorized to be placed in the market with this clarification. This special exception from the Ministry for conformity assessment provided is temporary and limited to essential COVID-19 Emergency Use Authorized(EUA) medical devices.
The publication clarified the exception approval for other procedural steps usually required to place individual medical devices on the market. However, applicants must send documentation of safety compliance for assessment by the Italian Ministry of Health.
Another development in the EUA certification process was the COVID-19 “work group,” created by the Italian National Institute of Health(ISS). This group is in charge of evaluating the EUA of medical masks without the CE marking. Companies with a quality system could self-certify to the ISS their responsibility for technical characteristics and safety of the masks.
No later than three days after self-certification, manufacturers must send any element useful for the validation of the masks.