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.
IVDR (EU) 2017/746: act now to be ready in time!
Considering the numerous and innovative requirements and the most stringent prescriptions, it is necessary to organize well in advance of the deadline. Furthermore, it is important to take into account that as the end of the transition period approaches, consultants, professionals and Notified Bodies will be more busy.
This White Paper can be useful to Manufacturers of in vitro Diagnostic Medical Devices, because it explains what the context of the IVDR Regulation is, what are the most important changes, such as the new risk classification of IVD devices, the role of Notified Bodies and the introduction of a Unique Device Identifier (UDI) for each IVD, in order to improve traceability and support activities relating to safety after marketing.
The document also contains information on deadlines, performance evaluation and compliance. Finally, there are some questions and answers to provide more details and clarifications.
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.
