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
UDI
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!
Registration
New for importers plus a lot more information required
EUDAMED
Maintenance of data will characterise the era of the EU MDR
Risk management
New requirements but not compared to ISO 14971
Vigilance
New 15 day norm for reporting serious incidents
Post Market Surveillance
Completely new requirements compared to the MDD