Class C IVDs — companion diagnostics, cancer screening, genetic tests — face the May 2026 IVDR deadline. Are you ready?

EU MDR & IVDRJonathan PhillipsJanuary 2, 2026Comment

The Commission's proposal COM(2025) 1023 to amend the MDR and IVDR: what it changes and what it means for manufacturers.

EU MDR & IVDRJonathan PhillipsDecember 16, 2025Comment

The EU has extended transition periods for legacy IVDs. The new dates, the conditions, and what to do to keep market access.

EU MDR & IVDRJonathan PhillipsDecember 11, 2024Comment

MDCG 2024-11 clarifies when a product qualifies as an IVD under the IVDR. The key points.

EU MDR & IVDRJonathan PhillipsOctober 31, 2024Comment

The European Parliament's push to overhaul the MDR and IVDR: what is on the table and why.

EU MDR & IVDRJonathan PhillipsOctober 25, 2024Comment

Where the MDR, IVDR and UK MDR transition deadlines stand after the extensions, and what still applies.

EU MDR & IVDRGuest UserJuly 10, 2024Comment

The Commission's 2021 proposal for a progressive IVDR rollout gave the industry more time. What it meant.

EU MDR & IVDRGuest UserOctober 14, 2021Comment

Regulatory updates