Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Obligations of economic operators, traceability, vigilance and market surveillance of medical devices as foreseen by the EU Commission Proposal for a Regulation on Medical Devices of 26 Sept. 2012: comparison with existing requirements and evaluation ***

Clelia Bonadei (Abschlußjahr: 2013)

Summary
Language: English

Together with medicinal products, medical devices are products that have widespread use in the healthcare sector.
In the European Economic Area (EEA), three basic directives regulate medical devices. They follow the so-called “New Approach”: flexibility is allowed as to methods employed by manufacturers to meet the essential requirements. Once compliance to the essential requirements is demonstrated, the CE mark of conformity can be applied to medical devices and they can be marketed in all states belonging to the EEA and in other countries that recognise the basic directives (Switzerland and Turkey).
The European Commission published, on 26 September 2012, a proposal for a new Regulation with the view to addressing, in the future, the weaknesses of the current directives, especially those that have been recognized as concurrent causes of the “PIP Scandal”.
The aim of this thesis is to give an overview of the current legislative framework in Europe for medical devices and to analyse the progress of the on-going legislative procedure and the most important changes introduced by the EU Commission’s Proposal for a Regulation of the European Parliament and the Council on medical devices.
Furthermore, this thesis has the aim of assessing some of the important proposed changes of obligations for economic operators and the variations brought in, namely:

• Traceability requirements
• Vigilance and market surveillance

in comparison with current requirements.

A discussion and an evaluation by the writer of the suitability of proposed changes to address the weaknesses of the current requirements are provided.
At the time of writing, the situation is yet evolving and discussions of the European Parliament and of the Council of the European Union are still being held.
Therefore, this work covers the situation and the content of official documents published by the European Commission and European Parliament up to June 2013.

Pages: 55, Annexes: 6 pages