The Italian Ministry of Health (MoH) has issued an explanatory note reporting how to place medical devices not compliant with the European requirements (i.e. non-CE marked devices) on the italian market.
According to the MoH:
- The procedure is applicable only to medical devices useful for the containment of the COVID-19 pandemic.
- The MoH will evaluate on a case by case basis and authorization time will change on a case by case basis.
- If granted, the authorization will be valid only for the time of the emergency and will be revoked as soon as the emergency is over.
Full text of the explanatory note in the following link
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