What is the purpose of EUDAMED?

What is the purpose of EUDAMED?

EUDAMED improves transparency and coordination of information regarding medical devices available on the EU market. The system is multipurpose. It is a collaborative and interoperable platform, that will functions as a registration system, a collaborative and a dissemination system (partially open to the public).

Is EUDAMED open to the public?

Eudamed is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission. The portal cannot be accessed by the public.

Who can access EUDAMED?

The European Database for Medical Devices (Eudamed) under the Medical Devices Regulation (MDR) and the In-Vitro Diagnostic Medical Devices Regulation (IVDR) will be partially accessible to the public. “The public” means in this context anybody with access to the Internet, anywhere the world.

What is MDR vigilance?

A MDR Vigilance plan must be set out as a component of the PMS plan required by Article 83. The Vigilance plan must include methods for: collecting data on serious incidents. distinguishing serious incidents from expected side effects. analysing serious incidents and procedures for escalating to competent authorities.

What are the 6 modules of EUDAMED?

Eudamed will include 6 interconnected modules:

• Actor registration, including SRN.
• UDI/device registration.
• Notified bodies and certificates.
• Clinical investigations and performance studies.
• Vigilance and post-market surveillance.
• Market surveillance.

What is EUDAMED and how is it structured?

How is EUDAMED structured? The EUDAMED system is multipurpose and will function as a registration system, a collaborative system, a notification system and a dissemination system (open to the public) and it will be interoperable. The database consists of six main modules: Actors registration.

Is EUDAMED operational?

Three additional modules—Clinical Investigations and Performance Studies; Vigilance and Post-market Surveillance; and Market Surveillance—will launch when the Eudamed database becomes fully operational in May 2022.

How do I register with EUDAMED?

EUDAMED notifies the Actor ID/SRN via email to the economic operator. To obtain an Actor ID/SRN, economic operators that are not non-EU manufacturers (EU manufacturers, authorised representatives, system/procedure pack producers and importers) must submit an actor registration request in EUDAMED.

What is MDR in pharma?

Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.

What is a vigilance report?

Vigilance Report means the incident report for death or serious injury required under the post market surveillance system as defined by the European Council Directive 93/42/EEC or the relevant and applicable equivalent of any other regulatory body.

What are the modules of EUDAMED?

EUDAMED will be composed of six modules related to: actor registration, unique device identification (UDI) and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and market surveillance.

Is EUDAMED compulsory?

The use of EUDAMED is not yet mandatory nor required. Some modules are already available, and can be used voluntarily. However, their use cannot be imposed.

Is EUDAMED active?

What is a PMS plan?

A PMS plan details a manufacturer’s strategy for continuously monitoring and collecting data and safety information on its device. The PMS plan is part of the device’s technical documentation and outlines the criteria for the risk/benefit assessment of the device and processes for: Collecting and analyzing data.

What is MDD standard?

The MDD is based on the principles of the “New Approach to Technical Harmonization and Standards”, a common set of regulations in the EU that standardizes technical requirements, testing and certification procedures.

What is Eudamed database?

Eudamed is a database that will be used to monitor the safety and performance of devices under the Medical Devices Regulation (MDR 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746).

What is medical vigilance?

The medical device vigilance system was set up to minimise risks to the safety of patients, users and others. Medical device safety issues can be identified through manufacturer, healthcare professional or through members of the public submitting reports to the HPRA.

What is field safety corrective action?

“Field safety corrective action is an action taken by a manufacturer to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device that is already placed on the market.