TÜV Rheinland10.01.19
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,” explained 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,” explained 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,” said 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 added “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.”
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,” explained 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,” said 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 added “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.”
