Explore the reform map: eight areas of change — MDR / IVDR 2.0 — What to expect and how to prepare — meddevo Academy

Explore the reform map: eight areas of change

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The reform map: eight territories

The Commission organised its proposal into eight reform areas. Click your way across all eight — each reveals what is proposed and what it would mean for your daily work. Remember: everything here is proposed, not yet law.

1 / 8 areas explored

Simplification & proportionality

Requirements scaled to actual risk

What the Commission proposes

Certificates lose their five-year expiry date — notified bodies run periodic, risk-proportionate reviews instead of full recertification.
The detailed qualification catalogue for the person responsible for regulatory compliance (PRRC) is dropped; SMEs no longer need their external PRRC 'permanently and continuously' available.
A wider range of data counts as clinical data, equivalence becomes more flexible, and 'New Approach Methodologies' such as in-silico testing are explicitly promoted.
A new 'well-established technology' definition replaces today's scattered device lists, unlocking lighter requirements.
Classification drops for several groups: reusable surgical instruments become plain Class I, software starts lower, accessories to active implantables are no longer automatically Class III.

What it means for you

Audit your portfolio against the new classification rules and the well-established-technology definition — some devices may face a notified body far less often, or not at all.

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