What's changed

It's more an update than a completely new regulation

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Timelines

From May 2017 until May 2025

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Classification

A number of new rules added to reflect advances in technology

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General requirements

Essential Requirements are renamed and expanded

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Clinical evaluation

Significant changes but not compared to MEDDEV 2.7/1

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Clinical investigations

Significant changes but not compared to ISO 14155

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Technical documentation

Aligned with the GHTF's "STED" format

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UDI

Every medical device uniquely identified

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Conformity assessment

Virtually unchanged, one less route (Annex VI) compared to the MDD

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Notified Bodies

The concept is retained but almost everything is going to change!

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Registration

New for importers plus a lot more information required

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EUDAMED

Maintenance of data will characterise the era of the EU MDR

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Risk management

New requirements but not compared to ISO 14971

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Vigilance

New 15 day norm for reporting serious incidents

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Post Market Surveillance

Completely new requirements compared to the MDD

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