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