The Czech Standardization Agency, in cooperation with medical device experts from the educational and consulting company Porta Medica, is publishing a new brochure "Transition Guide to the MDR" that serves as a comprehensive guide to key changes in the medical device industry. These changes are brought about by the amending Regulations (EU) 2023/607 and (EU) 2024/1860. The publication aims to help manufacturers, distributors and hospitals better navigate the new legislative requirements and prepare for their smooth implementation.
The guide takes a detailed look at two main areas brought about by the new legislation. In the first part, it is mainly the issue of extending the transition periods for so-called legacy devices, i.e. devices with conformity assessed according to previously applicable directives. The amending regulation extended the validity of certificates for certain legacy devices and allowed them to be placed on the market until 31 December 2028. However, manufacturers had to meet a number of conditions, such as implementing a quality management system according to the MDR and applying for re-certification by 26 May 2024. This step is to ensure that there is no shortage of medical devices on the market that could put patients' health at risk.
The second part of the publication focuses on the new possibilities of using the European Medical Device Database Eudamed. This information system is a key tool for tracking medical devices on the EU market. The amending Regulation allows the use of the different modules of the database even before its completion. This will simplify access to the information for distributors and hospitals and help manufacturers meet new regulatory obligations.
"Education and support for medical device suppliers is key for us. The publication of this brochure complements our other educational activities in this area, such as the publication of a commentary on the Medical Devices Regulation and the implementation of a three-year qualification course for PRRCs," says Zdeněk Veselý, Director General of the Czech Standardization Agency. "Our goal is to ensure that suppliers have all the information they need to compete in a competitive environment and to be able to market and supply their products without problems."
"The publication is intended not only for manufacturers and distributors, but also for hospitals and medical doctors who use medical devices in their practice and need to verify their legality. A side effect of extending the transition periods for legacy devices is to make this verification more difficult for healthcare providers who are faced with products in practice with an apparently expired certificate that remains valid under the new rules. Our guide will enable them to better navigate this complex environment," adds Jakub Král, co-author of the brochure and founding partner of Porta Medica.
The brochure is published free of charge in print and electronic form and is available on the website of the Czech Standardization Agency.