EUDAMED is LIVE

15 December 2020 |

shutterstock_534246544 (1)

The Medical Devices Regulation (EU) 2017/745 and In Vitro Diagnostic Regulation (EU) 2017/746 include use, maintenance and management of a European databank on medical devices (EUDAMED). The database consists of six main modules:

  1. Actor Registration – to identify all economic operators
  2. Unique Device Identification – to register product specific information
  3. Certificate – to form a database of EU certificates
  4. Clinical Investigation – to provide collection and analysis of clinical data
  5. Vigilance – for Incident reporting
  6. Market Surveillance – Publication of post-market reports from the Competent Authority

Operation of all six modules is necessary for full MDR / IVDR implementation and is currently foreseen by May 2022. The EU Commission, however, agreed to a modular implementation of the database and the first EUDAMED module, Actor Registration finally went live on 1 December 2020.

Economic Operators (e.g. manufacturers, importers, and EU representatives) are encouraged to register within the system and obtain a Single Registration Number (SRN) in order to be considered in compliance with the actor registration requirements of the Regulations.

To access the database, you will need to first create an EU login on the EU Login System (https://webgate.ec.europa.eu/cas). Follow the prompts in the Actor Registration module to enter your organisation’s details. EUDAMED will notify the National Competent Authority who will examine your request and provide approval via email.

We will continue to monitor progress in the implementation of EUDAMED, stay tuned for more updates!

We offer deep support for navigating international regulatory processes.  Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Reach out today and start a conversation. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ +61 2 9906 2984 (Sydney)

Disclaimer
The views and options expressed in this article are those of the author/s and do not necessarily reflect the views of Brandwood CKC Pty Ltd ACN 128 762 505.

The information presented in this article is of a general nature only and does not consider the particular circumstances of your business. Prior results and case studies do not guarantee a similar outcome in future. You should not rely on this information, and you should seek specific advice for your particular business needs.

Where indicated, certain content has been sourced from third parties; we have not independently verified it. Neither Brandwood CKC nor the author makes any warranty as to the accuracy, completeness or reliability of this article, nor do those parties accept any liability or responsibility arising in any way from omissions or errors contained in the content.

Search

Recent Posts

Categories

Categories

Archives

Archives

Archives