TÜV Rheinland: Notified Body for the New Medical Device Regulation

COLOGNE, Germany

TÜV Rheinland LGA Products GmbH is now a notified body for the EU Medical Device Regulation (MDR) 2017/745. The European Medical Device Regulation 2017/745 (MDR) came into effect on May 25, 2017, and will replace Directive 93/42/EEC (MDD) and Directive 90/385/EEC (AIMDD) on May 26 2020. “The EU Medical Device Regulation is much more comprehensive and detailed than the previous directives,” explains Zina Apostolou-Keiper, Head of the Medical Business Field at TÜV Rheinland. “Due to the complexity of the newly created legal framework for medical devices, all market participants will in the future be subject to more stringent requirements.”

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

TÜV Rheinland is one of the world’s leading independent testing service providers with almost 150 years of tradition. Employing over 20,000 people around the globe, TÜV Rheinland generates an annual turnover of 2 billion euros. The independent experts stand for the quality and safety of people, technology and the environment in almost all areas of business and life. TÜV Rheinland inspects technical facilities, products and services, accompanies projects, processes and information security for companies. The experts train people in numerous professions and industries. TÜV Rheinland has a global network of recognized laboratories, testing centers and training centers at its disposal for this purpose. Since 2006, TÜV Rheinland has been a member of the United Nations Global Compact for greater sustainability and against corruption. Website: www.tuv.com

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