Mª Carmen Abad Luna, Head of the Medical Devices Department at the Spanish Agency for Medicines and Medical Devices (AEMPS), gave a lecture on medical devices at the Royal Academy of Pharmacy of Catalonia on 10 May. Her talk was entitled «European Regulations on Medical Devices: a renewed legal framework in line with the sector’s impact and innovation». Indeed, it was the first session on medical devices in the history of the RAFC.
The event was organised by Section III (Industrial Pharmacy) and Section V (History, Legislation and Ethics) of the Academy. And it was a great success in terms of attendance. The RAFC’s auditorium was packed to the rafters. Some people even had to stand throughout the session. The event was introduced and moderated by the director of our office, Mercè Camps.
Royal Academy of Pharmacy. Session on Medical Devices led by Carmen Abad (AEMPS).
Carmen Abad’s lecture, on the Academy’s website.
The Royal Academy promotes the dissemination of knowledge regarding the regulations affecting products in the sector. For this reason, it has decided to publish the presentation given by the AEMPS expert. From today, it is available in the Other publications from its website, in PDF format.
This document is of great interest for two reasons:
- Firstly, because Carmen Abad, by virtue of her position at the AEMPS, speaks on behalf of the agency. Therefore, everything she says is an official statement. And she is speaking on behalf of the Spanish Agency for Medicines and Health Products.
- Secondly, because the new Regulations on Medical Devices and IVDs were published on 5 May, and this was the first time that someone from the AEMPS had spoken publicly about the new legal framework.
Let’s remember: there are new Regulations on Medical Devices and IVDs
For anyone involved in the sector, it is worth noting that two have been published New Medical Devices Regulations.
- The Regulation 2017/745 on Medical Devices, which comprises 175 pages, 123 articles, 10 chapters and 16 appendices)
- And the Regulation 2017/746 on In Vitro Diagnostic Medical Devices -IVD’s, comprising 157 pages, 113 articles, 10 chapters and 15 appendices).
For further information on the new regulations governing medical devices, please do not hesitate to contact our office. Our proposal: Solutions!