Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Investigator-Initiated Trials on Medical Devices - Legal Basis and Regulatory Aspects ***

Pia Helfrich (Abschlußjahr: 2012)

Summary

Language: English

With the 4th Amendment of the Medical Device Act (MPG) on 21st March 2010 tightened authorization procedures for clinical investigations with medical devices were introduced targeting improved safety and protection of patients and trial subjects, improved quality of clinical investigations and of resulting clinical data. One of the most important changes was the introduction of a mandatory authorization of clinical investigations by the national competent authority (Federal Institute for Drugs and Medical Devices, BfArM). Additionally a clinical investigation can only be commenced when a favourable opinion from an ethics committee has been obtained. Also the MPG stipulates the conclusion of an insurance policy with the trial subject as beneficiary. These provisions are applicable for clinical investigations within the scope of a conformity assessment of medical devices to gain marketability. As such clinical investigations are conducted for commercial reasons they are called “commercial” trials. Clinical investigations for other reasons, such as medical or scientific questions, are not liable to the MPG neither to the Ordinance on clinical investigations of Medical Devices (MPKPV). Sponsors of such clinical investigations are not the manufacturers of medical devices but the director of a hospital or a physician for example and they are called “investigator-initiated trials” (IITs), respectively “non-commercial” trials. Analysis of the experiences and positions of two organizations (Coordination Centres for Clinical Trials, ethics committees), who have to deal with the legal and regulatory framework of IITs and of clinical investigations within the scope of conformity assessment, identified possibilities of improvement concerning the legal and regulatory framework for IITs. An assured legal basis for IITs should be provided, which eliminates the discrimination of commercial and noncommercial trials of medical devices. This should best be achieved by incorporation of clinical investigations which do not serve the conformity assessment (including non-commercial trials as IITs) in the scope of the MPG.

Pages: 51, Annexes: 5 (pages: 18)