Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The planned transformation of Directive 98/79/EC on in vitro diagnostic medical devices into a Regulation. Possible regulatory consequences for the development and release of in vitro diagnostics ***

Andreas Vogt (Abschlußjahr: 2013)

Summary

Language: English

The aim of this master thesis is to explain the main changes which are planned by the transformation of Directive 98/79/EC on in vitro diagnostics (IVDs) into a regulation and to show the possible regulatory consequences for the development and release of IVDs. First of all, the current regulatory framework for IVDs is described which is in principle unchanged since the Directive 98/79/EC entered into force in 1998. The objectives and justification of the Proposal for a Regulation on IVDs which should for example enable the IVD legislation to become more flexible in respect to innovative IVDs like companion diagnostics or genetic tests are explained. The upcoming changes of the proposed Regulation on IVDs with a focus on IVD specific issues like the development of in house tests for IVDs, clinical evidence of IVDs and near patient testing IVDs are described. In particular, the proposed changes in the classification system and in the Conformity Assessment Procedures are discussed comprehensively since these changes will have the most significant consequences for the release and development of IVDs in the future. The relevance of the proposed changes is discussed by analysing the responses given by various stakeholders during the public consultation on specific aspects on IVDs held by the European Commission. In summary, most of the stakeholders should agree to the Proposal for a Regulation on IVDs since most of their suggestions were adopted in the proposal. Several specific product classes like near patient testing IVDs, high risk class IVDs and companion diagnostics are discussed to show the consequences for the development and release which differ severely based on the risk class of the IVD and size of the manufacturer. In respect to companion diagnostics the introduction of consultation procedures between the notified bodies and the national competent authorities or the European Medicines Agency responsible for medicinal products is an improvement in regard to the safety and trust in these products. However, additional work in bringing together the two different regulatory frameworks and the development of further specific guidance still has to be done. In conclusion, the planned transformation of Directive 98/79/EC into a Regulation will create a different regulatory environment for IVDs. It will be a more harmonised environment with less interpretation issues between Member States since the legislative tool of a regulation is chosen by the European Commission and several international definitions and principles established by the Global Harmonisation Task Force are adopted which should make the European IVD sector more competitive in future.

Pages: 53; Annexes: pages: 7