The EUDAMED database contains many routine and in vitro diagnostic medical devices from the single market. It also has another role that makes it indispensable. It is a platform that allows interaction between manufacturers and authorities, among other agents involved.  Thus, it serves to implement the regulations of the aforementioned medical devices based on Regulations (EU) 2017/745 and 2017/746. This European regulation implies the disappearance of national regulations. And, consequently, of the current Eudamed2 surveillance system.

Objectives of the EUDAMED database and traceability

  • Inform the general public. One of the objectives of EUDAMED is to ensure that the general public receives timely information about the products that will appear on the market, as well as the valid certificates issued by the bodies authorized for this function.
  • Identify the products. It also makes it possible to identify the uniqueness of each product on the domestic market. And, in this sense, traceability can be made easier.
  • Scientific dissemination. In this way, it is allowed to make the population and citizens, in general, have access to quality information on clinical research.
  • Compliance with the rules. One of the objectives of this database is that manufacturers are aware of the information obligations that the end consumer has and that they comply with this standard.
  • National authorities. The authorities of each Member State, as well as the Commission, must carry out their tasks following the regulations and cooperate to ensure compliance with European jurisprudence in this regard.

Improve traceability

  • All these objectives are aimed at achieving an improvement in traceability. For this reason, EUDAMED is a tool to improve traceability as well as the transparency of the medical devices that are circulating in the European Union market. And, at the same time, a backbone element that brings together the different agents involved in the framework of European regulations.
  • Improving traceability implies following a rigorous control of medical devices. It allows to carry out a more severe and safer health surveillance for consumers.
  • It is used to control the sources or reagents that are part of the product, the raw materials, and the place where the final product is installed or its commissioning.

Marking a medical device

  • The marking is linked to traceability because its function is essential in ensuring safety for the consumer. Thus, the CE Marking serves to identify those products that comply with the legal standards established by the European Union. In this line, if a product does not have this safety certificate, nor has it passed through the EU protocols, it will not be able to carry the CE marking.
  • The marking is mandatory for all manufacturers who wish to market their products within the European Union. This marking does not only apply to products that go on the market for the first time in this geographical area of influence. This marking affects, in the same way, products that are used or that are not first-hand but come from countries that are not in the EU and that enter European territory for the first time. They are also affected by this European directive so that EU citizens have the security of acquiring a product with the most rigorous certification and quality controls.

IP Triana

At IP Triana, we adapt to the standards and directives of the European Union. Our human and technical team achieves excellence so that our clients have the certainty and security of not taking the slightest risk and adapt to the regulations required by the EU market. We are backed by 50 years of experience in the sector.

 

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