The White Paper “Factsheet for Manufacturers of in vitro Diagnostic Medical Devices” explores the in vitro Diagnostic Medical Devices Regulation (IVDR) from the point of view of the Manufacturers.
The document provides information on the obligations and requirements must be fulfilled in order to be ready on 26 May 2022, the date of full application of the in vitro Diagnostic Medical Devices Regulation IVDR (EU) 2017/746.
The IVDR will replace the current directive relating to in vitro Diagnostic Medical Devices (98/79 / EC) (In Vitro Diagnostic Medical Devices Directive, IVDD). Its entry into force in May 2017 marked the beginning of a five-year transition period from the IVDD.
The IVDR (EU) 2017/746, together with the MDR Medical Device Regulation (EU) 2017/745, creates a solid, sustainable and transparent regulatory framework, recognized internationally and improves clinical safety, guaranteeing Medical Device Manufacturers- In vitro diagnostics fair market access.
Are you a Manufacturer of in vitro Diagnostic Medical Devices?
Fill out the form!
You will receive our White Paper directly on your inbox: a valuable help to understand the necessary actions to be taken to adapt to the IVDR and to be able to market your IVDR devices throughout Europe.
