Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The revision of European Directives on medical devices 90/385/EWG (AIMDD) and 93/42/EWG (MDD): Present requirements concerning clinical investigation and clinical evaluation in comparison to Commission`s proposal for a new Regulation on medical devices and those discussed by the EU Parliament and the Council in the course of the legislation procedure

Dr. Kerstin Bade (Abschlußjahr: 2015)

Summary
Incidents like PIP results in a loss of confidence of the EU population in the current conformity assessment procedure. Because of this a revision of current AIMDD and MDD and its replacement by a regulation has been seen as necessary. Through this a uniform level on the safety of patients and test-subjects will be set within the EU. Key elements for the conformity assessment procedure have been revised, such as the clinical investigation and the clinical evaluation. In comparison with current directives the future MDR will contain more requirements and demands in the conduction of a clinical investigation and the evaluation of clinical data. With the proposed MDR also an adjustment of requirements has been made to those high standards already set in international guidelines and for clinical trials on medicinal products for human use. Through current directives already set requirements also have been revised. For example it is proposed that the competent authority shall be notified of investigations with already CE-marked devices which are within its intended purpose but includes an additional burden for the test-subjects.
In the proposed MDR the possibility has been used to set higher demands on clinical investigation such as the strengthening of the position of the ethics committee. It is proposed that the approval of a clinical investigation by the member state is only possible if the investigation has also been assessed and approved by an independent ethics committee.
Requirements for high risk medical devices will become more strictly for the reason of patient safety. The commencing of a clinical investigation on high risk medical devices has to be approved by the concerned member state and an independent ethics committee. Also the obligation for investigations of high risk medical devices will be expanded e.g. to class IIb devices intended to administer and / or remove a medicinal product. At the same time the study-design has been specified as to be randomized – well controlled in the appropriate target population. For high risk devices also a restriction has been set in regard to the evaluation of clinical data and the possibility to use already available data from devices equivalent to the device under investigation. The high risk medical devices have also been exempted from the possibility of a clinical evaluation alone with data of non-clinical testing.
Through the intake of terminology such as "sponsor" or "ethics committee" the proposed regulation is harmonized to international standards in the conduction of clinical investigations.
Aspects towards transparency have been implemented via a new electronic system. This system will be partly accessible to the public for information e.g. submitted by the sponsor in regard to the application for the conduction of a clinical investigation. This electronic system will be also included in the proposed new application procedure by which prior to submission of an application for a clinical investigation a single identification number has to be generated. Also the registration of the clinical investigation prior to its start will be done in this system.
Not only intensification on requirements for clinical investigations has been proposed but also a possible simplification for manufacturers, planning the realization of multi-national investigations. The future procedure could be a single application submitted via the electronic system and a collective assessment through the concerned member state.
Until now the future MDR is nothing more than a proposal, but it shows the way in which future requirements will proceed. The council’s first reading position is waited on. The requirements on the conduction of a clinical investigations and the evaluation of clinical data will be more demanding especially for high risk medical devices.
Pages: 58