New regulation on medical devices made of substances: Opportunities and challenges for pharmacological and toxicological research

• Egile Nagusiak: Carmela Fimognari (Egilea), Enrique Barrajón-Catalán (Egilea), Cristina Luceri (Egilea), Eleonora Turrini (Egilea), Emanuel Raschi (Egilea), Elisabetta Bigagli (Egilea)
• Formatua: Liburua
• Argitaratua: Frontiers Media S.A., 2022-09-01T00:00:00Z.
• Gaiak: article
• Sarrera elektronikoa: Connect to this object online.

The Medical Device (MD) Regulation EU 2017/745 (MDR) has provided a completely new and more robust regulatory framework at guarantee of the safety and efficacy of therapeutic options accessing the market. At the same time, the MDR poses several challenges for stakeholders, among which, the most sign...