Module 18 2021

06/02/2021

• Operational since 2000

• Becomes operational in May 2022

IVD Directive

• IVDD is transposed into the

IVD Regulation

• The law text is in force in

national laws by the member

all member states

states

• Not 1:1 and with different national

• Higher classification of most of the IVD

interpretations

products

• Weaknesses like

• Stricter and extensive pre-market and post-

 Inadequate classification system  No transparency of what is on the EU market  Most of the products are self- certified by the manufacturer  Unprecise pre-market and post market documentation requirements

market documentation requirements

• Clear transparency of what is on the market

• Will strengthen the image and value of CE

marked devices

The new IVDR passport for Europe

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

8

The Organisation for Professionals in Regulatory Affairs

under the IVDR ?

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4