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Deutsche on Devices

Andreas Grund and Judith Thevarajah of GCP-Service assess the impact of regulations coming into place that govern the use of medical devices in clinical trials within Germany

After the US and Japan, Germany’s medical devices industry is the third biggest market in the world (1). More than 80 per cent of the German companies in this dynamic and innovative industry are small to medium-size (1,2). The product cycles are much shorter than those of the pharmaceutical industry, incurring high costs (seven per cent of the turnovers) for research and development (1). Although malfunctions of medical devices (see Figure 1) (3) and device-related adverse events (see Figure 2, page 46) (4) occur very frequently, unlike drugs, the conduct of a clinical trial is such that it is not mandatory to place a medical device on the market. Instead a CE-mark ( Communauté Européenne– European Community) is necessary. Depending on the product class of the medical device, the manufacturer has several ways to carry out the conformity assessment procedure to receive the CE-mark.

According to the European Directive 93/42/EEC, medical devices are grouped into four product classes (I small risk; IIa/ IIb middle risk; III high risk) (5). Class II and III clinical studies are usually required if no sufficient scientific literature are available. Any notified body within Europe can certify medical devices, yet notified bodies are not authorities but rather independent commercial companies (6). There are more than 50 notified bodies in Europe, of which 15 are in Germany (6,7). The manufacturer’s freedom of choice between notified bodies for CE-marking (6) creates competition, and the notified bodies approach the industry in order to licence their product to popular contact points.

REGULATIONS OF INVESTIGATIONS WITH MEDICAL DEVICES

Today the conduct of clinical studies with drugs is very well regulated. Meanwhile the parties involved such as sponsors and CROs, as well as investigators, are familiar with good clinical practice (GCP) (8). This trend is supported by the European Directive 2001/20/EEC which came into force in April 2004, that implements GCP into the national drug laws of the European member countries (9).

On a European level the medical device market was already regulated in 1990 by the Directive 90/385/EEC (11) for active implantable medical devices and in 1993 by the Directive 93/42/EEC for other medical devices (5). Both documents refer to the necessity for clinical data to lie within the conformity assessment for CE-marking. In particular, article 15 of the Directive 93/42/EEC deals with the requirements for clinical investigation. Paragraph 2.2 indicates that clinical investigations have to be in compliance with the Declaration of Helsinki, which ensures that all precautions to protect humans are made mandatory. This applies to every single step of the clinical investigation, starting from the first considerations about the necessity and authorisation for the investigation, up to the publication of results (8). Each step from organisation and execution, to documentation and reporting in context of clinical research is described in the GCP guideline. This guideline cannot be converted one-to-one for studies with medical devices; therefore the European standard EN 540 was developed.


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Andreas Grund (MSc, PhD) has worked in the clinical research area since 1997. After his study of human nutrition science, he was responsible for investigator initiated trials at the University of Kiel, Germany. Between 2000 and 2004 he worked in different positions for Omnicare Clinical Research and Inveresk. In 2004, Andreas founded the CRO GCP-Service in Bremen, offering clinical monitoring, project management, training and consultancy services for Phase I to IV drug studies and devices studies within Europe.

Judith Thevarajah (MSc) studied Biology in the Technical University of Braunschweig, Germany and at the Ohio State University, USA. She focused on genetics, cell biology and microbiology and finished her study in 2004. Having spent two years in London, since the beginning of 2006 she has worked for GCP-Service as clinical research associate and concentrates intensively on the medical device trial regulations in Europe.

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Andreas Grund
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Judith Thevarajah
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