Module 18 - Drug Device Combinations and Other Technologies

30/11/2023

2022, May 26 All new products must comply

2026, May 26 Transition period Self-Declared to Class C

2027, May 26 Self-Declared Class B, Sterile A

2025, May 26 Transition period Self-Declared to Class D

2017, May 26 IVDR entry into force

IVD-R

8 years transition period

26 May 2025 for Class D devices 26 May 2026 for Class C devices 26 May 2027 for Class B devices 26 May 2027 for Class A devices placed on the market in sterile condition

IVD-D

REGULATION (EU) 2023/607 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices

Transition timelines from the Directive to the new IVD Regulation

The Organisation for Professionals in Regulatory Affairs

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Reagent

… whether used alone or in combination ,

Calibrator

intended by the manufacturer to be used in

Control

vitro for the examination of specimens

Piece of equipment

It can be

Kit

including blood and tissue donations, derived

from the human body, solely or principally for

the purpose of providing information

Software or System

Instrument

Apparatus

 see next slide

What means in vitro diagnostic medical device under the IVDR ?

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The Organisation for Professionals in Regulatory Affairs

10

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