Did you know..
A notified body is an organisation designated by an EU country to assess the conformity of certain products before being placed on the market. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation when a third party is required. The European Commission publishes a list of such notified bodies. When an EU country informs the Commission and the other EU countries that a body has been designated to carry out conformity assessment according to legislation it’s called notification. The notifying EU country is responsible for their withdrawal and notification of notified bodies. Several documents related to the designation of notified bodies under the new regulations were adopted by the medical devices coordination group.
As a consulting firm, specialized in technical and legal procedures for Cosmetics, the Biosanitary and Medical devices industry, we have many services to offer to your project
As a consulting firm, specialized in technical and legal procedures for the Biosanitary and Medical Devices industry, M Camps GTF offer you technical services por Span and e EU territory.
Assessment and preparation of the required documentation to obtain the Parapharmacy National Codes, for further presentation to the General Council of Official Colleges of Pharmacists
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.