The In Vitro Diagnostics Directive (IVDD) 98/79/EC (IVDD) for in vitro diagnostic medical devices is revised to establish a robust, transparent, predictable, and sustainable regulatory framework for in vitro diagnostic medical devices which ensure a high level of safety and health whilst supporting innovation.
The aim of the new In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 is to ensure the smooth functioning of the internal market as regards in vitro diagnostic medical devices, taking as a base a high level of protection of health for patients and users.
The IVDR is applicable to in vitro diagnostic (IVD) medical devices. Entering into force on 25 May 2017 providing a five-year transition period for manufacturers and economic operators.
The new regulation for in vitro diagnostic device provides significant changes to the regulatory requirement for an e.g. reclassifying the device based upon the risk, product scope extension, more precise clinical evaluation for in vitro diagnostic (IVD) medical devices, etc.
If you are already certified under 98/79/EC (IVDD) and your certificate is due expiry or you wish to proactively comply to the updated regulation, Maven can help you with our bunch of experts who are involved in gap analysis based upon your product range, certification cycle, and your notified body.
We can perform an in-depth gap analysis of your technical documentation, procedure, process, and QMS, and recommended you how to fill the gaps, Gap analysis is done by our product experts and includes a review of your;