This guidance is to help sponsors and manufacturers of in vitro diagnostic (IVD) medical devices transition to new manufacturer evidence requirements.
Many sponsors and manufacturers of IVD medical devices will need to transition to new manufacturer evidence because of:
the new European Union IVD Regulation 2017/746 (EU IVDR) that replaces the EU IVD Directive 98/79/EC (IVDD) and
the end of the transition period for the TGA to accept many ISO 13485 certificates as manufacturer evidence.
Sponsors who need to transition to new manufacturer evidence will need to act to ensure ongoing regulatory compliance. The extent of those actions will depend on a range of factors and this guidance covers a range of scenarios and examples to help identify the correct pathways and sponsor actions.
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