Under the EU Medical Device Regulation and the EU In Vitro Diagnostic Medical Device Regulation, organisations that want be recognised as notified bodies must obtain a new designation. According to Assobiomedica (the association of medical device suppliers), the number of notified bodies in Italy that have applied for said designation is low. This has led to questions around what will happen if notified bodies fail to obtain the new designation and what liability they will face regarding manufacturers and patients?
The Lazio Administrative Court recently decided that, as a rule, parallel importers of medicinal products have no right to change the trademark affixed to products in their country of origin unless this change is strictly necessary due to safety grounds or national regulatory restrictions. The court found that the right to undertake the parallel import of medicinal products should not unduly take advantage of the national reputation and trust built by the marketing authorisation holder in the products' state of origin.
The Italian Competition Authority (AGCM) recently launched an investigation into the online sale of dietary supplements in Italy based on claims of non-compliance with the relevant regulatory provisions, resulting in misleading actions. The AGCM's role in this context is to ensure that consumers obtain accurate information concerning dietary supplements so that they can make informed decisions concerning these products.