Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

A Regulatory View on Application Devices ***

Imke Teuffel von Birkensee (Abschlußjahr: 2013)

Summary

Application devices are a small niche within the wide area of medical devices and medicinal products although they are to find all-around.
They represent a wide range of different products - from a simple spatula provided with semi-solid pharmaceutical forms to more complex inhalation devices or pre-filled syringes and pen devices. The need and benefit of application devices to facilitate and enhance correct administration of medicinal products is highlighted. Different types of application devices – if single integral part of a medicinal product or separately – are categorised and presented in the thesis. This is supported by examples of approved products. Furthermore the special case of closed reconstitution devices is discussed regarding their classification.
Concerning application devices two regulatory regimes – medical device law and medicinal product law - touch each other. These products need to be reviewed and approved by device agencies or medicinal product agencies or even both. This demands careful attention to the requirements of both regimes by regulators and companies during development.
On the one side, the device part of an application device is assessed in Europe in compliance with the Medical Device Directive 93/42/EEC as amended while on the other side a medicinal product has to comply with the Medicinal Product Directive 2001/83/EC as amended and the national transformation of these frameworks respectively. Placed onto market separately, the regulatory requirements would depend on the law as appropriate. But many application devices yet contain the medicinal product and therefore become subject to medical device law as it is stated in the Medical Device Directive.
The aim of this master thesis is to give an overview on the regulatory framework and its appliance for application devices with a focus on separate application devices. The legal basis in the EU and the US regarding the regulatory pathway and their differences regarding this topic are discussed. Furthermore the requirements for approval of such combinations of medicinal product and application device with focal point on the EU are given. This includes also applicable guidelines and other requirements and aspects to be considered regarding handling and suitability of an application device as well as prevention of potential medication errors.

Pages: 61, Annexes: pages : 8
Total pages: 78