The Review of Regulatory Framework Applicable to the Medical Devices Sector: State of Play

Abstract

The future of the European regulatory framework for medical devices is under review. From the work initiated by the Commission, in 2008, resulted two legislative proposals (one regulation on medical devices and active implantable medical devices and another concerning in vitro diagnostic medical devices), which were submitted to the Council and to the European Parliament in September 2012. Over the past three years, these proposals have been subjected to detailed scrutiny and active discussion by the Member States and the European Parliament. Currently, negotiations in the Trialogue are developing in an atmosphere of flexibility and at a good pace, which allows foreseeing the possibility of an agreement between the three parties (Commission, Council and Parliament) at a first reading, and therefore the publication of the Regulations in 2016. In this context, this article aims to inform on the negotiation process of the future European regulatory framework applicable to medical devices, providing a state of play regarding its evolution and emphasizing the participation of INFARMED, I.P. as competent authority, mainly on the technical and regulatory support to the adopted national positions.

Keywords

• Device Approval; Equipment Safety; Equipment and Supplies; Europe; Government Agencies
• Government Regulation; Mandatory Reporting; Patient Safety/Legislation & Jurisprudence; Portugal; Product Surveillance
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