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Before a medicinal product can be licensed in Europe or Germany, the manufacturer must prove that it meets a large number of requirements. These include
- pharmaceutical quality (for instance the composition, purity, manufacturing process, monitoring of the precursors, intermediates and finished products, shelf-life studies, etc.)
- efficacy (such as the causal link between the medicinal product and the desired therapeutic outcome)
- harmlessness (particularly the harmfulness and efficacy of the medicinal product are to be compared here with the severity of the disease)
The Federal Institute for Drugs and Medical Devices is responsible for licensing a medicinal product in Germany, and the European Medicines Agency is responsible for licensing over Europe. A licence initially applies for five years as a rule. It is re-examined after this whether the greater use of the medicinal product has caused side-effects which are disproportionate to the benefit.
Medical devices must meet certain pan-European safety and performance requirements, that is the basic requirements. The fact of a medical device complying with the basic requirements is demonstrated during the conformity assessment procedure. This is largely carried out by the manufacturers on their own responsibility. The conformity assessment procedure consists of
• a risk management procedure
• a clinical evaluation, and
• a risk-benefit analysis.
If the medical devices meet all the requirements, manufacturers can apply a “CE label”. With medical devices from higher risk classes, a designated agency is involved in the testing. These are independent testing and certification agencies which are designated and monitored by a state institution in each Member State. In Germany this is the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices. The manufacturers of medical devices themselves select within Europe the designated agency which is to evaluate their products.
If the manufacturers have their main office in Germany, and if a medical device is brought onto the market for the first time, they must report the first placing onto the market to the responsible authority in the respective German Land.
Medical devices with a “CE label” can be sold all over the European Economic Area. The certificates that are issued by a designated agency are time-limited and must be renewed at regular intervals.