Regulatory pathway · all topics

EU In Vitro Diagnostic Regulation (IVDR)

Regulation (EU) 2017/746 (IVDR) replaced the IVD Directive on 26 May 2022. New risk-based classification (Class A, B, C, D) with most assays now requiring notified body involvement (was ~20% under IVDD, now ~80% under IVDR). Performance evaluation and post-market performance follow-up are mandatory. Transitional provisions extended through 2027-2029 for many existing assays.

Source

Regulation (EU) 2017/746, In Vitro Diagnostic Regulation

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0746

How MedTek OS handles this

Compass drafts the eu in vitro diagnostic regulation (ivdr) workflow with confidence-gated content.

The platform refuses to generate content below the threshold for this artifact class. Every claim carries a citation chain back to RIG, audit-logged with HMAC integrity.

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