CHAPTER

4
The Medical Device
Regulation (EU MDR
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2017/745)

CONTENTS
4.1. What is the Medical Device Regulation (EU MDR 2017/745
or MDR)? ....................................................................................... 84
4.2. Major Differences Between The Medical Device Directive
(MDD) 93/42/EEC and Medical Device Regulation
(MDR) 2017/745 ............................................................................ 84
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 Medical Device Regulations: Transitioning from MDD 93/42/EEC to MDR 017/745
84

4.1. WHAT IS THE MEDICAL DEVICE REGULATION

(EU MDR 2017/745 OR MDR)?
The medical device regulation (MDR) was published on May 26, 2017, with
the aim of replacing the medical device directive (MDD) and the Active
Implantable Medical Devices Directive. The MDR will replace the current
EU MDD (93/42/EEC) and the EU’s Directive on active implantable medical
devices (90/385/EEC). All currently certified medical devices and active
implantable medical devices must be recertified such that they comply with
the new requirements of the MDR. The MDR was meant to come into effect
on May 26, 2020, but this has now been delayed for a year to May 2021.
The In-vitro Diagnostic Regulation (IVDR) replaced the IVD Directive, and
comes into effect on May 26, 2022. The new MDR provides an additional
time after the date of application allowing placing new products under the
MDD for a grace period.

4.2. MAJOR DIFFERENCES BETWEEN THE MEDI-

CAL DEVICE DIRECTIVE (MDD) 93/42/EEC AND
MEDICAL DEVICE REGULATION (MDR) 2017/745
The basic structure and requirements of the Regulation remain the same as
that of the MDD however a summary of the major differences between the
MDD 93/42/EEC and the MDR 2017/745 is provided below:
• There is a wider and more detailed scope of EU legislation which
has been extended to include a greater variety of devices such as
implants for aesthetic purposes.
• There is much stronger supervision of notified bodies (NBs) by
national authorities.
• The rights and responsibilities for manufacturers, authorized
representatives (AR), importers, and distributors have been
defined more clearly.
• There is an extended database on medical devices (known as
Eudamed) which aims to provide a more comprehensive and
public information source on devices that are available on the EU
market.

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 The Medical Device Regulation (EU MDR 2017/745)
85

• More stringent rules for clinical investigations on devices.

• Introduction of classification rules that divide the broad range of
in vitro diagnostic medical devices into four different risk classes
as it already exists for other medical devices.
• Creation of a medical device coordination group composed of
members representing national competent authorities (CA) in the
field of medical devices to ensure better coordination between
member states.

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EBSCOhost - printed on 4/2/2024 7:18 AM via UNIVERSITY OF ECONOMICS HO CHI MINH CITY. All use subject to https://www.ebsco.com/terms-of-use