Skip to content

MDR Booklet including M5

This booklet offers a full overview of the EU Medical Device Regulation (MDR) and includes the latest M5 amendment.

Request the booklet now!
MDR Booklet M5 mockup

What information does the booklet contain?

The Regulation (EU) 2017/745 on medical devices (Medical Device Regulation – MDR) has been mandatory since May 26, 2021 and forms the main content of this booklet. Additionally, the booklet includes: 

  • a sampling plan for technical documentation
  • practical guidance for organizations
  • TÜV NORD diagrams illustrating the conformity assessment procedure.
Fields marked with an asterisk (*) must be filled in.

Your contact details

Explore related certification services

Certification

ISO 13485

ISO 13485 - Quality management system for medical devices
Explore ISO 13485 certification
Certification

MDSAP

MDSAP Audit (Medical Device Single Audit Program) - An audit for five markets
Explore MDSAP certification
Certification

ISO 9001

A quality management system in accordance with ISO 9001
Explore ISO 9001 certification