Masterstudiengang "Drug Regulatory Affairs"


Quality of Medical Devices Incorporating a Medicinal Substance Having Ancillary Action in the EU – Requirements According to Medical Device Regulations and According to Medicinal Products Regulations

Susanne Igl (Abschlußjahr: 2008)

Language: English

One special medical device type consists in medical devices which incorporate as an integral part a medicinal substance which, if used separately, may be considered to be a medicinal product and which is liable to act upon the body with action ancillary to that of the device.
The present thesis relates to the quality requirements to be fulfilled before access to market is granted for this type of product.

According to Directive 93/42/EEC (the Medical Device Directive - MDD), these medical devices are regarded as medical devices and therefore the conformity assessment procedure according to the MDD is to be followed; but additionally a scientific opinion from one of the competent authorities for medicinal products on the quality and safety of the medicinal substance including the clinical benefit/risk profile of the incorporation of the substance into the device is needed (consultation procedure).

With regard to the quality requirements according to medical device regulations the requirements to be fulfilled are defined by the MDD providing information on the conformity assessment procedure to be followed and providing information on the essential requirements to be fulfilled. Different types of conformity assessment procedures are possible: for example, the manufacturer has to ensure application of the quality system approved for the design, manufacture and final inspection of the products concerned (full quality assurance system). Usually the certification of quality systems is based on the corresponding (DIN) EN ISO guidelines. The essential requirements are general requirements and requirements regarding design and construction. Compliance with harmonised standards (known as EN (ISO) guidelines) provides presumption of conformity to the corresponding essential requirements. Compliance with harmonised standards remains voluntary and manufacturers are free to choose any other technical solution that provides compliance with the essential requirements. Due to the many different medical device product types the medical device regulations are described in a very general way and therefore allow a flexible approach to their fulfillment.

With regard to the quality requirements according to medicinal products regulations the following topics regarding quality are to be addressed within the consultation procedure: General information on and description of the medical device, qualitative and quantitative particulars of the constituents, description of the method of manufacture, controls of the medicinal substance, control tests carried out at intermediate stages of the manufacturing process of the medical device, control tests on the finished product and stability. The respective medicinal products regulations and guidance documents have to be applied. However, there are several aspects where the medicinal products regulations may have to be adapted with regard to the different characteristics of medical devices and, furthermore, with regard to the special characteristics of each product. There is no special advice or guidance provided by the authorities on how to apply (or adapt, if necessary) medicinal products regulations with regard to medical devices incorporating a medicinal substance with ancillary action, but in case of questions scientific advice may be sought from the medicinal products authorities.

Pages: 44, Annexes: pages: 10