INFARMED gathered, for two days, the main European decision-makers in the Medicinal Products and Medical Devices sectors in a meeting to discuss the new legislative framework for Medical Devices (MD) and In Vitro Diagnostic (IVD) medical devices, the challenges and possible solutions, including the need to improve the articulation and cooperation between the medical devices and the medicinal products sectors.
During this Monday and Tuesday, the virtual meeting was attended by some 140 heads of the Group of Heads of National Medicines Agencies (HMA), heads of the National Competent Authorities for Medical Devices (CAMD), and representatives from the European Medicines Agency (EMA) and the European Commission (EC), specifically the Directorate-General for Health and Food Safety (DG Sante).
During the first day, the participants from the national agencies and the European entities worked together to take stock of the implementation of the two MD and IVD Regulations, always focused on actions capable of promoting health protection and the interest of the patient, the citizen, and the health professional, as well as the promotion of and access to innovative and emerging products.
In the joint meeting between CAMD and HMA, which took place on the second day, chaired by the INFARMED's President, Rui Santos Ivo, a structured dialogue allowed them to conclude about the need to identify and put into practice adequate structures, tools, procedures that allow the reinforcement of coordination and decision capacities in the medical devices sector at European level, particularly regarding complex monitoring and market surveillance actions, based on the acquired experience. In this way, a faster and more appropriate response will be achieved to the needs of safety and public confidence in the regulatory bodies of the Medicines and Medical Devices sector.
It was also reaffirmed the positive impact foreseen by the reinforcement of the EMA's competence (which are being implemented) in terms of managing disruptions and supporting the panel of experts established by the DM Regulation.
The Minister of Health, Marta Temido, participated in the opening of the joint session, expressing the support of the Portuguese Government in the cooperation effort between Member States and in the proper implementation of the new regulatory framework for medical devices. She also expressed her full commitment to ensure the implementation of the agreement to strengthen the mandate of the EMA in the next European Council of the sector.
Since the beginning of the year, INFARMED has been responsible for coordinating the set of 20 meetings of the various Committees and Working Groups that foster the progression of work in the areas of Medicine and Medical Devices in order to meet the objectives for this sector and assumed by the Portuguese Presidency.