Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Comparison of combined and related sets of medical devices with medicinal products, considering also the coming regulation for medical devices

Birgit Harrer (Abschlußjahr: 2015)

Summary
Language: English
Several new medicinal products and medical devices are developed and put on the market in Europa every year. The classification respectively categorisation and accordingly the line between both is often difficult to define for the manufacturer, the Competent Authority or Notified Body: is the new invention to be classified as a medicinal product or a medical device? Will an approval process of a Competent Authority (CA) be required or is a conformity assessment procedure necessary, even with the involvement of a Notified Body? These questions are substantial for a manufacturer to get his invented product quickly on the market without infringement of the law. It is furthermore important to save the patient by adequately tested and correctly approved products taking also into consideration the intention of use of the product.
The classification of such borderline products and its underlying laws and guidelines will be discussed on the following pages. Starting with the definitions of a medical device and its intended of use, followed by the medicinal products and borderline products. Special focus will be kept on the comparison of fixed combined and on the other hand on related sets of medical devices with medicinal products. Both consist of a medicinal product and a medical device and are used in combination, but are classified differently because of their nature being one fixed unite of a medicinal product and a medical device or regarded as two separate units.
A special chapter is dedicated to the Guidance of Borderline products, MEDDEV 2. 1/3 rev 3, giving an overview on the classification of borderline products.
The approval process is also an important process in the life of a borderline product, depending on its classification of its main intention of use either as medical device or medicinal product.
Examples on borderline decisions should support an easier classification / assignment or better understanding for this area – only the European Court of Justice is allowed to ‘give an authoritative interpretation of Community law’.
The new proposal of a Regulation for medical devices, currently under creation, will bring up a new common law in Europe and will also be considered in this work.
Pages: 36