On Tuesday 15 March, the M. Camps Pharmaceutical Technical Consultancy coordinated the course, as part of the UB-IL3 training programme, New European Regulation on Medical Devices. The event, which took place at the IL3 premises in Barcelona, brought together speakers from the public and private sectors – featuring keynote speeches by senior officials from AEMPS, FENIN y Anefp-, and more than 70 registered students took part.
The course began at 9 o’clock in the morning, when the participants’ documents were collected and Mercè Camps, director of GTF and course coordinator, introduced the training day and the teaching staff. The first talk was given by Carmen Abad, head of the AEMPS’s Medical Devices Department, who gave a keynote presentation on the changes that the forthcoming regulations on medical devices will entail.
After the coffee break, María Aláez (FENIN) spoke about the new classification rules, María Concepción Rodríguez (AEMPS) on the clinical aspects of the new Regulation and Anna Amich (ALCON) on the monitoring and post-marketing surveillance of medicinal products once the new Regulation has been adopted.
In the afternoon, it was the turn of Maite López-Gil (ANEFP), who spoke about the labelling provisions in the new PS Regulation, and Salvador Cassany (Pharmaceutical and Medical Devices Control Service of the Catalan Government’s Department of Health, which focused on advertising of medical devices in Catalonia – And finally, we attended the presentation by Fabio Tommasi Rosso (Kiwa Cermet), who spoke about the EUDAMED and UDI databases, in accordance with the new Regulation.
The event, which was a great success in terms of attendance and received very positive feedback from participants, made it clear that there is still a great deal of work to be done. However, it also shed light on certain aspects of the future of medical devices, such as their regulation and the clinical trials to be carried out. That said, we would like to make it clear that, whilst the Regulation will serve to harmonise legislation across the EU, we will need to take into account any specific provisions that individual Member States may add to the new legislation.