(European Database on Medical Devices) EUDAMED Database Services by Hibcc Pakistan.

EUDAMED Services By HibccPakistan. EUDAMED is a database used to track and monitor medical equipment. It consists of the UDI (Unique Device Identification) and BUDI modules (Basic UDI-DI). Devices with the same risk class are grouped together using the UDI module. It is not applied to the supply chain..

What exactly does European Database on Medical Devices mean?

An online database called EUDAMED, or the European Databank on Medical Devices, offers details on EU medical device regulations. It is a crucial tool for enhancing market oversight and fostering medical device transparency. Although EUDAMED can not provide details on specific items, it can assist authorities in making sure that medical devices adhere to the highest standards.

 

EUDAMED is a database maintained by the European Commission that aims to improve transparency and accessibility of medical device information on the EU market. The database will also strengthen the coordination between the EU Member States. It will include information such as field safety notices submitted by manufacturers. The database is expected to be available in stages until it is fully operational in May 2022.

Between Class I and Class II devices, there are different EU requirements. Higher-classified gadgets are subjected to a stricter evaluation than lower-classified ones. Directives 90/385/EEC and 93/42/EEC are in charge of these regulations. In May 2020, the new Regulation (EU) 2017/745 will take the place of the earlier Directives. Numerous ISOs are also applicable to various kinds of medical devices.

What Data is Store in Eudamed?

A database called Eudamed will monitor the effectiveness and security of medical equipment and other products. The European Commission created it to facilitate swift access to regulatory data by competent national agencies and to encourage uniformity in the application of medical device rules. Additionally, Eudamed is more significant than the Medical Devices Directives database, which it replace.

A safe web-based site called Eudamed will act as the hub for the exchange of regulatory information concerning medical devices. The database allows users to view particular data without disclosing their identities. the 20th of May 2022. Eudamed will be fully functional and allow users to access various regulatory documents on medical devices. If a device has unique characteristics or is use in a particular environment, it may require additional documentation.

The Eudamed database includes details of authorized users, restricted users, and public websites. It also provides information on the registration process and the role of the European Commission in registering authorities and granting access.

1.Module ACT – Actor Registration

The EUDAMED Actor Registration Module (ACT) enables economic operators to register and submit their SRN data. The Module will be available to EU member states from December 1, 2020. The EUDAMED database will allow for better coordination among member states and improve the transparency of medical device information.

Actors may include Competent Authorities, manufacturers, and others. EUDAMED will provide a user interface to facilitate the manual input of data and some machine-to-machine uploads. To prepare for the Module’s implementation, actors should monitor the European Commission website for updates on technical specifications. The MDCG strongly recommends that actors use the SRN on their certificates.

The first of six EUDAMED modules is the Actor Registration Module. Article 33 of the Medical Devices Regulation (EU) 2017/745 is responsible for its development. An actor in EUDAMED is a natural or legal person who plays a particular part in the regulatory framework for a medical device. Economic operators, supervising entities, and Competent Authorities are some of the actor roles.

2.Unique Device Identification module

Unique Device Identification (UDI) is an essential step in improving patient safety. The system helps healthcare providers identify a medical device’s purpose and risk factors, improve data capture and record keeping, and reduce diagnostic errors. It also helps medical devices be distribute more securely and helps prevent counterfeiting and fraud.

UDI require Medical device labelers to provide the Global Unique Item Identifier Database with 62 points of information regarding each device. This data will make it easier to locate a medical device quickly and connect it to other pertinent FDA data. The public will soon be able to access the study via a variety of channels. In order to read the barcode scanners and AIDC technology, UDIs will give in a plain-text format.

The device’s serial or lot number, as well as the date of manufacture, are represent by the UDI, an alphanumeric or numeric code. It makes it possible to identify devices without human error. The application identifiers of the issuing agency are use to generate the UDI (AI). Devices and software are also identify via the UDI-DI.

 

3.Module CRF – Certificate

The regulating organization for medical devices in Australia is call the Therapeutic Goods Administration (TGA). The Department of Health and Ageing is where it belongs. The nation is build of several smaller islands as well as the continent of Australia and the island of Tasmania. It is the sixth-largest country in terms of total area and the most populous country in Oceania.

The majority of businesses that produce or distribute medical devices demand registration of those goods. The Code of Federal Regulations’ Title 21 CFR Part 807 provides details on this requirement.

The FDA charges businesses a fee each year to register their devices. They must also list their trade names and formal correspondents. The business must also list the names of all of its officials, directors, and partners.

Manufacturers of legacy devices must register their products to enable post-market surveillance, perform field safety corrective actions, and manage adverse events. There are several resources available to assist with the process of registration. The European Commission’s Medical Devices website provides technical documents, videos, and an infographic to help economic operators understand the process.

4.Module CIPS – Clinical Investigation

The Module CIPS – Clinical Investigation of Medical Devices facilitates the communication of information related to clinical investigations. It enables the exchange of results between Notified Bodies and authorities and allows the public access to specific clinical investigation reports and related documentation. It also facilitates coordination and cooperation amongst the competent authorities of EU Member States.

Module CIPS focuses on good clinical practice, specifically when investigating medical devices in human subjects. It outlines the scope of clinical investigations for medical devices, summarizes essential provisions, and provides valuable recommendations for designing pre and post-market clinical studies. The Module also discusses the orienting principles of the clinical investigation process as it pertains to the EN ISO 14155:2020 standard and the MDCG guidance documents.

Regulation (EU) 2017/745 also contains provisions that require the sponsor to inform the Member States of any changes made to the clinical investigation. However these changes must be communicate within one week. If the changes affect the medical device’s safety, reliability, or robustness, they must be notified to the relevant Member States immediately.

5.Module VGL – Vigilance

The Vigilance Module is part of the EUDAMED regulatory framework. It enables manufacturers to report incidents, adverse events, and trends to relevant authorities and facilitates post-market surveillance. Additionally, the Module oversees clinical trials and performance studies and promotes collaboration among EU members.

They make the mechanism is design to make it easier for Member States to coordinate their market surveillance efforts. So it offers a central location for information exchange and enables member states to submit information on market monitoring and economic operator inspections. Member states must make These reports public. Authorities will exchange the information.

 

In addition to the reporting requirements for devices, EUDAMED will also require using an SRN. This unique ID will identify economic actors throughout the EU. The system will be accessible to manufacturers, notified bodies, and the commission.

6.Module MSU – Market Surveillance

The EUDAMED module enables manufacturers and other actors to register for the database and make their information publicly available. These actors will be identify by an Actor ID or a Single Registration Number. This information will be publicly available once the competent authority verifies it.

Also the EUDAMED module is intend to provide the most excellent transparency possible for the customers of medical devices. EUDAMED will require each manufacturer to register with the system to achieve this. This will allow consumers to identify the manufacturers of medical devices. The Module will enable consumers to learn more about the manufacturers and how they manufacture and sell their products.

In addition, the EUDAMED module will improve the transparency and coordination of medical device information. However, it is incredibly complicate and confusing. With 6 modules, it cannot be apparent to interpret what information a device manufacturer needs to submit. In addition, the information materials provided by the EU are often challenging to understand and raise more questions than answers. if you have any query for eudamed services feel free to contact us.