For those familiar with the Medical Device Directive, here is a summary of key changes:


An overview of what's changed

It's more an update than a completely new regulation


The transition timelines

From May 2017 until May 2025


Classification rules

A number of new rules added to reflect advances in technology


Essential requirements

Essential requirements are renamed and expanded


Clinical evaluation

Significant changes but not compared to MEDDEV 2.7/1


Clinical investigations

Significant changes but not compared to ISO 14155


Technical documentation

Aligned with the GHTF's "STED" format



Every medical device uniquely identified


Conformity assessment

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


Notified Bodies

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



New for importers plus a lot more information required



Maintenance of data will characterise the era of the EU MDR


Risk management

New requirements but not compared to ISO 14971



New 15 day norm for reporting serious incidents


Post Market Surveillance

Completely new requirements compared to the MDD