Hogan Lovells updates

New medical device regulations: what liability do notified bodies face?
Hogan Lovells
  • Healthcare & Life Sciences
  • Italy
  • 13 February 2019

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?

Parallel import of medicinal products – when a name change is a game changer
Hogan Lovells
  • Healthcare & Life Sciences
  • Italy
  • 10 October 2018

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.

AGCM takes action against online sellers of dietary supplements
Hogan Lovells
  • Healthcare & Life Sciences
  • Italy
  • 25 July 2018

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.

Supreme Court upholds first class action relating to medical devices
Hogan Lovells
  • Healthcare & Life Sciences
  • Italy
  • 16 May 2018

After seven years, the Supreme Court finally ended the first product-related class action promoted in Italy relating to a medical device. The decision is noteworthy, despite the small sum awarded, because very few class actions have been declared admissible to date and even fewer cases have been upheld on the merits due to strict admissibility requirements.

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