New Eudamed central database
A key element of the new MDR is the introduction of a central European database for medical devices (Eudamed). “The Eudamed database aims to improve market surveillance and transparency, ensure the traceability of medical devices and facilitate the flow of information among manufacturers and operators of medical devices, notified bodies, Member States and the EU Commission,” explains Zina Apostolou-Keiper. Various databases are to be integrated in Eudamed, including the database for the registration of devices with a unique device identification (UDI) number as well as databases for economic operators, conformity assessment procedures, certificates, notified bodies, incidents and clinical studies.
Increased requirements for notified bodies
In the opinion of the European Union institutions, the proper functioning of notified bodies is crucial for ensuring an even higher level of quality and safety of medical devices. The designation processes and procedures for monitoring notified bodies are now governed more comprehensively and defined in greater detail, with the aim of further harmonizing requirements. “For example, notified bodies are obligated to employ doctors and/or clinical experts to a greater extent and to ensure the rotation of lead auditors during monitoring audits,” says Zina Apostolou-Keiper. Furthermore, it is now anchored in the legal text that notified bodies shall conduct an unannounced audit of the certificate holder at least once every five years. Dr. Hartung: “This is intended to provide greater certainty that manufacturers always produce their devices in full compliance with the applicable regulations. Product testing is also a key element of these audits.”
For more information about the MDR and TÜV Rheinland’s medical device services, visit https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34 or https://www.tuv.com/world/en/eu-medical-device-regulation-mdr-2017-745.html.
TÜV Rheinland is a global leader in independent inspection services, founded nearly 150 years ago. The group maintains a worldwide presence of more than 20,000 people; annual turnover is EUR 2 billion. The independent experts stand for quality and safety for people, technology and the environment in nearly all aspects of life. TÜV Rheinland inspects technical equipment, products and services, oversees projects, and helps to shape processes and information security for companies. Its experts train people in a wide range of careers and industries. To this end, TÜV Rheinland employs a global network of approved labs, testing and education centers. Since 2006, TÜV Rheinland has been a member of the United Nations Global Compact to promote sustainability and combat corruption. Website: www.tuv.com
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