Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
Necessity of consultation procedures on medical devices incorporating a medicinal substance ***
Rita Jochum (Abschlußjahr: 2008)
Language: English
The European legislation foresees a special proceeding for medical devices incorporating, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act upon the body with action ancillary to that of the device. The Notified Body carrying out a conformity assessment procedure in respect of such a medical device consults a competent authority for medicinal products on the medicinal aspects of the device, which is called consultation procedure. This is to verify the compatibility of the medical device and the medicinal substance. This means that the manufacturer of such a medical device incorporating a medicinal substance with ancillary action has to spend a lot of time, effort and money, because the manufacturer must - in addition to the standard requirements for a conformity assessment procedure - typically submit detailed data on the quality, safety and usefulness of the incorporated medicinal substance.
This master thesis further investigates a problem that was pointed out by Dr. Ehrhard Anhalt (Bundesverband der Arzneimittel-Hersteller e.V. (BAH) - Bonn) in his publication Bedürfen Medizinprodukte mit Arzneimittelanteil immer eines Konsultationsverfahrens? [Medizinprodukte Journal (MPJ) 2007, 4: 196 197] with regard to those stipulations. He highlighted a discrepancy in the wording of section 7.4 of Annex I between the English version and the German version of Council Directive 93/42/EEC on Medical Devices as amended (MDD). As a consequence of the wording of the German version, a consultation procedure concerning the medicinal substance would strictly be necessary with all medical devices incorporating a medicinal substance without exception, i.e. independent of whether or not the concentration of the medicinal substance in the device is a pharmaceutically or pharmacologically active one. As a consequence of the wording of the English version, only if the concentration of the medicinal substance in the device is adequate for an ancillary action and only if it is pharmaceutically or pharmacologically active, a consultation procedure concerning the medicinal substance would be necessary. But if the medicinal substance in the device does not act in this way, then a consultation procedure would not be necessary. After all, different national interpretations of the legislative rules on medical devices incorporating ancillary medicinal substances in the European Union can be of consequence for the marketability of this kind of devices. On that account this master thesis further investigates the discrepancy shown above. It examines for selected Member States of the European Union (Spain, France, Sweden, Ireland, United Kingdom, Germany and Hungary) whether section 7.4 of the Essential Requirements (in Annex I to the MDD) and Classification Rule 13 (in Annex IX to the MDD) as well as their corresponding transposition into national law also differ from the English version of the MDD. The question is considered under what circumstances those selected Member States deem it necessary to carry out a consultation procedure on a medical device that contains an integral medicinal substance for the purpose of assisting its functioning. A search on criteria defining under what conditions the integral medicinal substance acts ancillary to the device was done. The law-making procedure of Council Directive 93/42/EEC is studied under the aspect of the primary intention of the stipulations concerning devices incorporating, as an integral part, a 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. Existing guidances in the European Union (EU) are examined and the common practice and opinions in the selected EU countries are inquired. At the end of this thesis a short global outline is given in order to get a view of how medical devices incorporating ancillary medicinal substances are regulated outside of the EU.
What is clearly demonstrated in this thesis is that there indeed are different interpretations and stipulations as to the execution of consultation procedures on medical devices incorporating a medicinal substance with ancillary action. And there definitely is need for discussion. Thus, to avoid such discrepancies, further interpretation, discussion and guidance as to the necessity of consultation procedures on medical devices incorporating a medicinal substance with ancillary action is needed in the authors opinion. For instance, this could take place in the framework of the so-called recast of the medical devices directives in the EU.
Pages: 46, Annexes: 1, pages: 2