Background
According to European Commission a web-based portal EUDAMED is being developed to implement Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices. The system consists data on medical devices that have been collected and registered by Competent Authorities and the European Commission and can only be accessed by these same parties. The amount of data which will be available to the European Authorities through EUDAMED is the most significant changes being introduced by the new European Union Medical Device Regulations (EU MDR) Article 33. This data collection with EUDAMED was established by the Medical Device Directive (MDD) Article 14a. But the amount of data made available to the European Authorities has been minimal compared to what is envisaged in the new EU MDR. This ‘MDR EUDAMED’ is intended to provide more data, of higher quality and with a wider accessibility. EUDAMED aims at improving transparency and coordination of information regarding medical devices available on the EU market.
Database Access
The ‘MDR EUDAMED’ will not only be used by the National Competent Authorities (NCAs) and the European Commission. Depending on the type of user, only certain levels of the databank can be accessed. It will also be accessed by:
Database Module
EUDAMED will function as a registration system, a collaborative system, a notification system, and a dissemination system (open to the public) and will be interoperable. EUDAMED is structured around 6 interconnected modules and a public website:
One of the key objectives of the Medical Devices Regulation (MDR) is transparency aiming at providing a larger access to relevant information to the public and strengthening public and patient confidence in the safety of medical devices placed on the EU market. These obligations in MDR will be applicable once the EUDAMED is fully functional.
Key information accessible to the public in EUDAMED:
Key information publicly available outside EUDAMED
Important EUDAMED Dates
For the EU Commission this development and implementation of EUDAMED is a high priority. And with help of MDCG, it is going to release different modules as soon as they become functional. Currently the deployment of Actor registration (first module) is planned for December 2020. The module on UDI/device registration (second module) and the module on Certificates and Notified Bodies (third module) will become available by May 2021. Afterwards, the remaining modules will be presented as soon as they are operational. Most of the requirements on Transparency and public access to information linked to the EUDAMED, are planned to become fully functional by May 2022. The official web address of the EUDAMED public website will be “ec.europa.eu/tools/eudamed”. It will be available once it is in production and not before.
Turacoz Healthcare Solutions understands medical device regulatory MDR requirements and can assist you in your device approval journey. Our technical writers are experienced industry experts having worked with EMA, FDA and other regulatory agencies in gap analysis, device approval and regulatory queries responses. In addition to the regulatory services, the team also provides publication, medi-marketing and advisory board meetings for medical device companies.
If you have any queries, email us at [email protected].
References
“Write the paper as though no editor will ever see it … then let a good editor make sure everyone
World Thyroid Day invites us to appreciate the tiny, butterfly-shaped gland with a big job in managing our body’s energy,
In an era where speed, efficiency, and personalization have become imperatives, Artificial Intelligence (AI) — particularly machine learning, AI algorithms,
Every 8 May, World Thalassemia Day shines an international spotlight on the millions of people living with this inherited genetic disorder.
Ovarian cancer remains one of the most challenging gynaecologic malignancies, often referred to as a “silent killer” due to its subtle onset and late-stage diagnosis.1 In 2022, 324,603 women worldwide were diagnosed with ovarian cancer.
The healthcare landscape is being reshaped at an unprecedented pace, powered by sophisticated data analytics, emerging technologies, and the escalating
Biosimilars—biologic medicines that are highly similar to FDA-approved originator biologics—offer a cost-effective alternative without compromising clinical efficacy.1,2 Since the first
Communications In a rapidly evolving digital ecosystem, the pharmaceutical industry’s relationship with content is undergoing a seismic shift. At the
By Turacoz Healthcare Solutions | World Liver Day 2025 In a world where social media dominates wellness discussions, liver health
The healthcare industry is experiencing a paradigm shift as patient voices take center stage in drug development and approval processes.
Partner with Turacoz to bring science to life through strategic and evidence-based communication.