The Royal Academy of Pharmacy of Catalonia Last Wednesday, 10 May, it hosted a public session on the new European Medical Devices Regulations. The event stemmed from a joint initiative between two sections of the Academy: Section III, Industrial Pharmacy, and Section V, History, Legislation and Ethics. It was moderated by Mercè Camps, head of our office and a member of the RAFC.
The session featured a presentation by Mª Carmen Abad Luna, Head of the Department of Medical Devices at the Spanish Agency for Medicines and Medical Devices (AEMPS). Abad gave a presentation entitled “European Regulations on Medical Devices: a revamped legal framework in line with the sector’s impact and innovation”.
Royal Academy of Pharmacy. Session on Medical Devices led by Carmen Abad (AEMPS).
New Regulations on Medical Devices and In Vitro Diagnostics
Firstly, it should be explained that the event was particularly significant for one reason. And that is because it is exactly a week ago today that the New Medical Devices Regulations.
- The Regulation 2017/745 on Medical Devices (175 pages, 123 articles, 10 chapters and 16 appendices)
- The Regulation 2017/746 on In Vitro Diagnostic Medical Devices -IVDs (157 pages, 113 articles, 10 chapters and 15 appendices).
Furthermore, it was the first public appearance in which the head of Medical Devices at the AEMPS, Carmen Abad, was talking about these regulatory changes.
Royal Academy of Pharmacy. Session on Medical Devices led by Carmen Abad (AEMPS).
New Royal Decree on Medical Devices
During the presentation, Carmen Abad officially announced that, following the publication of the new European regulations, it will be necessary to issue a new Royal Decree. In other words, Spanish legislation that covers aspects not included in the Regulation. For example, the advertising of medical devices and IVDs.
Furthermore, Abad explained, these changes will also entail “an amendment to the text of the Law on Guarantees”.
Royal Academy of Pharmacy. Session on Medical Devices led by Carmen Abad (AEMPS).
A successful session at the Royal Academy Pharmacy
Firstly, we would like to congratulate Sections III and V of the Royal Academy of Pharmacy of Catalonia. The session was a success, particularly as it was the first time the topic of medical devices had been addressed. What’s more, this comes at a time when the sector is undergoing a period of renewal.
We would also like to highlight the large number of attendees. In fact, every seat in the RAFC auditorium was taken. There were even some people who had to stand throughout the session. Finally, we would like to encourage the Reial Acadèmia to continue organising all kinds of conferences relating to medical devices.