The September issue of Regulatory Focus features articles that took an in-depth look at the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), where global medical device leaders explored the nuances of the new requirements and answered the industry’s most challenging questions. Qserve is proud to have been published in September's issue of Regulatory Focus with multiple articles.
Current medical device regulations in both Europe and China require that Clinical Evaluation Reports (CERs) be based on Guidelines on Medical Devices (MEDDEV), CFDA Technical Guidelines for the Clinical Evaluation of Medical Device in addition to clinical evaluation requirements contained in MDR. China has attempted to use slightly modified EU guidance for CER submissions; however, although requirements in the guidelines between EU and China may look similar, CERs for China written using EU guidance are always rejected by Chinese authorities. Regulatory specialists, Jasmin Hunter and Michael Yan, explain how to write a CER based on China’s National Medical Products Administration (NMPA) guidance and how to convert and submit existing EU CER requirements for China.
According to IVD expert Sue Spencer, it is essential when reading IVDR it is essential to not skip the preamble because it sets the “scene” and the priorities of the EU in writing the regulation. The In Vitro Diagnostic (IVD) Directive was never updated, while the Medical Device Directive (MDD) has experienced a series of gradual changes. In the article, Sue shares her knowledge on the key elements of IVDR, including device classification changes, oversight, clinical evidence and performance evaluation and postmarket vigilance.
MDR poses many new questions and provides a variety of challenges for the medical device industry and while there are many regulatory changes, there is little explicit information in MDR for projecting what the impact the regulation may have on the Design and Development (D&D) process. Regulatory leader, Keith Morel, presents a number of regulatory changes in the article and covers several questions important to manufacturers regarding clinical evidence, clinical data, clinical evaluation, clinical safety, clinical performance, clinical outcomes and how they may fit together under new requirements.