In Vitro Diagnostics – IVDR & International IVD Compliance
Regulatory Confidence for Innovative Diagnostic Products
European regulatory requirements for in vitro diagnostic medical devices place significant emphasis on product classification, technical documentation, performance evaluation, and the availability of appropriate scientific evidence.
Avary Consulting supports IVD manufacturers in implementing Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation – IVDR).
Our services address classification rules under Annex VIII, technical documentation requirements under Annexes II and III, and performance evaluation and performance study requirements under Article 56 et seq. and Annex XIII.
Particular attention is given to scientific validity, analytical performance, clinical performance, and the consistent documentation of supporting evidence.
For international markets, we support the assessment of relevant FDA requirements and country-specific regulatory approval procedures.
Our services include:
IVDR classification and regulatory strategy
Assessment of regulatory requirements and documentation gaps
Planning and coordination of performance evidence
Support for performance evaluation activities
Coordination with testing laboratories and external partners
Technical documentation support and regulatory remediation
Our Recommendation: Companies should evaluate their performance evaluation strategy and the availability of suitable scientific, analytical, and clinical data early in development. This helps identify additional evidence requirements and supports realistic regulatory project planning.