Module 18 - Drug Device Combinations and Other Technologies

30/11/2023

• Operational since 2000

• Became 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

7 7

7

Classification changes with IVDR

The Organisation for Professionals in Regulatory Affairs

8

4