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.