ivdr translation:In vitro medical diagnostic device regulation
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IVDR is an acronym for the English on in vitro diagnostic medicalregulation, which means in vitro medical diagnostic device regulation.
The European Union enacted the In Vitro Diagnostic Medical Devices Regulation (IVDR) on May 5, 2017, which came into force on May 25, 2017, and will be implemented on May 26, 2022.
The IVDR is the first in vitro diagnostic medical device regulation in the European Union.
Medical device products marketed in the EU are required to bear the CE marking, and obtaining the right to use the CE marking requires an audit by a competent authority, and the IVDR is the regulation for such audits.
Since most of the previous IVDD products were carried out in a self-proclaimed mode, and 90% of in vitro medical diagnostic device products are now regulated under the IVDR, which requires a substantial registration process, one can simply interpret the IVDR certification as the new CE marking for in vitro medical diagnostic devices.
Secondly, compared with IVDD, IVDR has undergone a fundamental change in classification rules. IVDR changes the original IVDD's method of categorizing List A, List B, and other products into one that classifies all in vitro diagnostic devices into four categories, A, B, C, and D, based on the risk of the product, from low to high. The core change is that the product classification is clearer, and remove the vague notion of other items; in addition, it also strengthens the involvement of the announcement body.
The European Union is one of the core target markets for medical device manufacturers and the second largest market for in vitro diagnostic devices in the world. Meeting the requirements of the IVDR regulation has a significant and far-reaching impact on manufacturers.
Since the IVDR has changed a lot compared to the IVDD classification rules, in order to avoid the impact on the existing healthcare system due to the switchover of the regulation, and to realize the "soft landing" of the regulation, there is a 5-year transition period from the entry into force of the IVDR regulation to its implementation.