Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
4th Amendment of the Medical Devices Act: First experience with the new application procedure for clinical trials exemplified by an EU-funded multinational trial
Judith Beer (Abschlußjahr: 2011)
In recent years the significance of medical devices has become increasingly important. With a wide range of roles and functions, medical devices are used in an infinite number of areas. Although medical devices are of great value in many areas of daily life, their real significance is little known. Mainly in the modern healthcare sector they play a fundamental role and are often irreplaceable.
Nevertheless the way from the first idea and the need of a new medical device to a certified, CE-marked medical device on the European market is often long. Knowledge of and compliance with all laws and regulations is one of the major obstacles in the development of a medical device.
The implementation of Directive 2007/47/EC into national law in the European Member States until 21st March 2010 led to significant changes of the legal situation for medical devices especially in Germany. With a special focus on the protection of patients and subjects, the amending law led to a strong alignment of the application procedure for clinical investigations with medical devices.
A positive opinion of an independent and interdisciplinary Ethics Committee registered at the Federal Institute for Drugs and Medical Devices (BfArM) was one of the basic requirements for the conduct of a clinical investigation with medical devices in Germany until 21st March 2010. Only a notification of the competent authorities was required before 21st March 2010. This simple notification procedure was replaced by a new complex online application procedure, which implemented even further changes in various legal ordinances and led to a paradigm shift within the entire procedure.
Although the amending law was supposed to harmonize the procedures on European level and to implement European Directives, the complex changes made were merely of national importance. Through the Ordinance on clinical investigations of Medical Devices (MPKPV) of 13th May 2010 a detailed implementation of the revised 4th section (§§ 19-24) of the Medical Device Act (MPG) became effective.
The submission procedure for clinical investigations with medical devices was completely restructured by the update of the MPG and the implementation of the MPKPV. The reorganization of the Medical Device Information System (MDIS) of the DIMDI to a barrier-free SmartSearch user-interface facilitated the implementation of the DIMDIs new responsibilities and duties. The fact that the entire MDIS is available in German only already is and will be a big challenge for all sponsors, manufacturers or authorized representatives not mastering the German language in the near future. The present master thesis analyses the new application procedure and the functions and user-friendliness of the MDIS, exemplified by an EU-funded multi-national trial from a sponsors perspective.
All in all the technical implementations of the new MDIS and the application procedure in spring 2010 ran smoothly. Due to continuous updates on the part of the DIMDI, and the authorities (CA and EC) all important procedures and templates are optimized on an ongoing basis.
Although the review and assessment times in the other participating European countries (Austria, France, Italy, The Netherlands, UK) were considerably shorter than the German review and assessment times, the positive aspects of the new application prevail nearly one year after the implementation.
The new application procedure is the basis for a new age of paper-free applications in Germany. A lot of improvement is still necessary at present, but once it is completely established, it will not only increase the study participants safety but also minimize the users risks.
Apart from close collaboration, mutual concession of all parties involved is indispensible to achieve this common goal.
Pages: 69
Annexes: 4 (pages: 12)