2 Meddev Solutions Limited (RAPS e-Book version)
Background to the IVDR Chapter 2
BACKGROUND TO THE IVDR
Many people reading this guidebook will be aware of how and why we have a new regulation for In
Vitro Diagnostic Devices coming to Europe. If you are not aware here is a brief history to bring you
up to speed.
Due to public outcry over medical device scandals such as metal on metal hip implants and the infamous PIP
breast implant incident, European regulators have recognised the shortcomings of the directives in
protecting users and created a more expansive, stricter regulation for both medical and In Vitro
Diagnostic devices.
Also considering the advancing technology of diagnostics, the ability of member states to interpret
directives at a local level and the inadequate device traceability within the supply chain,
the existing directives required review.
The legislative process for this review involved three parties, the European Commission, the
European Parliament and the European Council.
In September 2012 the European Commission adopted a Proposal for a Regulation of the European
Parliament and of the Council on in vitro diagnostic devices to replace the IVDD. The proposal states ‘The
existing regulatory framework for In Vitro Diagnostic Devices has demonstrated its merits but has also come
under criticism in recent years. This revision aims to overcome these flaws and divergences and to further
strengthen patient safety. A robust, transparent and sustainable regulatory framework for In Vitro Diagnostic
Devices that is 'fit for purpose' should be put inplace. This framework should be supportive of innovation
and the competitiveness of the In Vitro Diagnostic Device industry and should allow rapid and cost-efficient
market access for innovative IVDs to the benefit of patients and healthcare professionals.’
In June 2016, the new proposed regulation on In Vitro Diagnostics was agreed at political level as the
result of a “Trilogue” negotiation between the three European parties. The European Regulation 2017/746 on
In-Vitro Diagnostic Devices was formally published in the Official Journal of the European Union on 5th May
2017, which started a transition period of 5 years to full application of the IVDR by the 26th of May 2022.
The legislation, now being in the form of a Regulation rather than a Directive, means it is directly applicable
to a member state, without requiring transposition through specific national legislation (and subsequent
inconsistencies).
CHAPTER 2
Background to the IVDR Chapter 2
BACKGROUND TO THE IVDR
Many people reading this guidebook will be aware of how and why we have a new regulation for In
Vitro Diagnostic Devices coming to Europe. If you are not aware here is a brief history to bring you
up to speed.
Due to public outcry over medical device scandals such as metal on metal hip implants and the infamous PIP
breast implant incident, European regulators have recognised the shortcomings of the directives in
protecting users and created a more expansive, stricter regulation for both medical and In Vitro
Diagnostic devices.
Also considering the advancing technology of diagnostics, the ability of member states to interpret
directives at a local level and the inadequate device traceability within the supply chain,
the existing directives required review.
The legislative process for this review involved three parties, the European Commission, the
European Parliament and the European Council.
In September 2012 the European Commission adopted a Proposal for a Regulation of the European
Parliament and of the Council on in vitro diagnostic devices to replace the IVDD. The proposal states ‘The
existing regulatory framework for In Vitro Diagnostic Devices has demonstrated its merits but has also come
under criticism in recent years. This revision aims to overcome these flaws and divergences and to further
strengthen patient safety. A robust, transparent and sustainable regulatory framework for In Vitro Diagnostic
Devices that is 'fit for purpose' should be put inplace. This framework should be supportive of innovation
and the competitiveness of the In Vitro Diagnostic Device industry and should allow rapid and cost-efficient
market access for innovative IVDs to the benefit of patients and healthcare professionals.’
In June 2016, the new proposed regulation on In Vitro Diagnostics was agreed at political level as the
result of a “Trilogue” negotiation between the three European parties. The European Regulation 2017/746 on
In-Vitro Diagnostic Devices was formally published in the Official Journal of the European Union on 5th May
2017, which started a transition period of 5 years to full application of the IVDR by the 26th of May 2022.
The legislation, now being in the form of a Regulation rather than a Directive, means it is directly applicable
to a member state, without requiring transposition through specific national legislation (and subsequent
inconsistencies).
CHAPTER 2