We offer senior advice in technical and legal procedures for the biosanitary and Medical Devices industry. We advise you and perform any procedure related to Medical Devices in general, and for IVDs (In Vitro Diagnosis).
Authorization for the facilities of manufacturing / importing companies
Registration of distribution companies
Technical File for Medical Devices
(Dosier Técnico del Producto Sanitario)
(Comunicaciones de primera comercialización)
Authorization for Medical Devices Advertising
(Autorización sanitaria de Publicidad)
Single identification of the product: What will be possible with the new UDI system for Medical Devices?
In April 2013, the European Commission issued a recommendation concerning a common framework for a single identification system for medical devices in the EU. This was intended to lay the foundations for the EU's future identification and traceability infrastructure, in line with the latest developments worldwide.
Since then, the European Commission has promoted, through the publication of Article 26 of Regulation (EU) 2017/745 on Medical Devices, and Article 23 of Regulation (EU) 2017/746 on Medical Devices for In-Vitro Diagnostics, two essential initiatives aimed at providing coverage to the UDI system:
- The creation of the Medical Devices database Eudamed (whose name is an acronym for European Database on Medical Devices).
- The creation of the European Medical Device Nomenclature (EMDN) body, which provides support and facilitates the creation of the Eudamed database.
UDI: Identification that is primarily aimed at the safety of EU consumers
In short, the new Unique Device Identifier system – UDI will facilitate the traceability of medical devices. In parallel, post-market activities relating to product safety will also be stronger and will allow better monitoring by the competent authorities.
In addition, the European Commission, using EMDN, has created a FAQ document relating to the Unique Device Identifier – UDI. Read her now!
Unique Device Identifier (UDI) in Medical Devices
Click at the link to visit the European Commission’s Unique Device Identifier – UDI website, where you will find all the information about the European Medical Device Nomenclature (EMDN) initiative and Eudamed, the new European Medical Device'sDatabase.
This web portal, created by the European Commission, is a space that will allow you to know, at first hand, all the official information from the health authorities in the euro area and all the new developments in relation to the new Unique Device Identifier - UDI and its implementation process.