Medical Devices & Life Science

Our Law Firm has always worked with medical devices. In particular, the co-founder Silvia Stefanelli has been active in this field since the mid '90s and currently provides advice and assistance in the implementation of the new EU Reg. 2017/745 and EU Reg. 2017/746.

The Firm also has specific expertise in the manufacturing and marketing of Personal Protective Equipment, assisting companies in the application of EU Reg. 2016/425.

Furthermore, the related expertise in data protection (EU Reg. 2016/679) and health law allows the firm to assist clients in the emerging areas of e-Health, Health Technology Assessment and, in general, technological innovations in healthcare.
We assist and advise companies in the following areas:

  • product implementation and development (co-development agreements, research and development, licensing and acquisition/sale of intellectual property rights, technology transfer and know-how);
  • clinical investigations (contracts with public administrations, informed consent, insurance, contracts with CROs, management of data obtained from investigations);
  • implementation of technical documentation (legal compliance check, assistance in drafting the IFU)
  • relationship with Notified Bodies (contract analysis, change of NB, disputes with NB)
  • assistance in relations with the Italian Ministry of Health and other competent European authorities (contacts with Ministries and database entry)
  • national and international trade agreements (OEM OBL, distribution, copromotion, franchising, procurement and contracts for the use of medical devices)
  • relations with health professionals and health administrations in the marketing phase (doctors, sales representatives, health care facility managers
  • assistance in the creation of promotion and advertising campaigns
  • assistance in tenders
  • administrative, regulatory, intellectual property and competition law litigation
  • assistance in the prevention and management of anti-corruption issues
  • assistance with regard to corporate crimes (analysis of contracts and of the relevant product market)
  • implementation of management systems pursuant to Leg. Decree 231/2001 on company crimes and related legal assistance.
osservatorio europeo dispositivi medici

European Medical Devices Observatory

The Observatory collects the most significant news related to the implementation of the EU Reg. 2017/745 (so-called MDR) to assist operators in the sector in complying with the new European legislation.