MDR / IVDR 2.0 — What to expect and how to prepare

11 lessons1 h 32 min9-question quiz

The EU Commission has proposed the biggest overhaul of the MDR and IVDR since they took effect. Follow Vera, a Head of Regulatory Affairs, through the eight reform areas of COM(2025) 1023: what would change, what stays, where the legislative process stands — and what your team should (and should not) do about it today.

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Curriculum

1How we got here: from MDR to 'MDR 2.0'9 minFree preview
2Explore the reform map: eight areas of change10 minFree preview
3Everyday relief: certificates, reports and deadlines

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4Predictable certification and flexible evidence9 minFree account

5Orphans, breakthroughs and sandboxes8 minFree account

6Game: Then vs. Now — sort the rulebook8 minFree account

7Digital, AI and cyber: the connected file8 minFree account

8The legislative journey: where the file is now6 minFree account

9Bonus: Inside Parliament's draft report9 minFree account

10The MDR 2.0 jargon decoder6 minFree account

11Vera's playbook: how to prepare without gambling9 minFree account