The In Vitro Diagnostic Device Regulation (EU) 2017/746 was published in May 2017 and replaces the IVD Directive (IVDD) 98/79/EC. The new regulation aims to overcome the current flaws and divergences and further strengthen patient safety via a robust, transparent and sustainable regulatory framework that is ‘fit for purpose’.
This guide aims to support you prepare for the changes, it is relevant to all IVD manufacturers and includes:
- Key changes introduced in IVDR
- Scope of regulated IVDs
- Classification Rules
- Conformity assessment procedures
- Person responsible for regulatory compliance
- Increased role of Notified Bodies
- Timetable for introduction and transition.
Only 20% or so of IVDs in the EU are currently subject to Notified Body approval. This will increase to 80% under the new IVD regulation and will consequently lead to increased approval times.
By taking certain measures, such as developing a customised action plan, will ease the introduction and transition to the new regulation.
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