With the new In Vitro Diagnostic Device Regulation (IVDR) scheduled for publication at the end of Q1 2017, will your organization be ready?
Find out why this new regulation is necessary and how you can pro-actively take certain measures to ease the introduction of, and transition to, the new regulation once it comes into effect.
With the aim of tightening and strengthening the approval system for IVDs, the IVDR introduces a number of changes, some of the key ones being:
- Scope of regulated IVDs
- Classification and conformity assessment requirements
- Identification and traceability
- Performance evaluation report
Download this guidance document to get a head start on preparing for the changes.