Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Requirements for and assessments of medical devices utilising animal tissues and their derivatives ***

Petra Sulzer (Abschlußjahr: 2009)

Language: English

The aim of this thesis is to describe the requirements for medical devices utilising animal tissues and their derivatives to be fulfilled by the involved parties, such as manufacturer, Notified Body and Member States. Another focus is the presentation of different conformity assessment procedures for medical devices utilising tissues of transmissible spongioform encephalopathy (TSE) susceptible species and for medical devices utilising species non-susceptible of TSE.
Type, origin and amount of animal tissues used in medical devices differ significantly. Animal tissues or their derivatives can represent an essential part of the medical device, but can also be part of the coating or impregnation. There are several reasons, why medical devices of animal origin are used instead of material of synthetic origin. In many cases material of animal origin exceeds synthetic material with respect to its ability to be integrated into the body and in its ability to support healing.

There are also risks associated with the manufacture and usage of medical devices utilising animal components. There is a risk that the animal tissue is contaminated by parasites, bacteria, or fungi. Also the final product or impurities in the product can cause pyrogenous, immunological or toxic reactions to the patient and to users. Another risk to be considered, is the contamination by viruses and infectious agents, for example TSE agents. Risk management procedures covering the whole life cycle of the medical device have to be applied to ensure the safety of patients, users and contact persons during manufacture. Risk management elements of the standard EN ISO 14791 are combined with those of the standard series of EN ISO 22442 referencing to the Annex of Directive 2003/32/EC. The review of risk management procedures, executed by the manufacturer and reviewed by the Notified Body and the same concerning the verification of compliance with the essential requirements are the key items of the EC conformity assessment procedures. There are differences between the EC conformity assessment procedures for medical devices utilising material of TSE-susceptible species on the one hand and for medical devices utilising non-TSE-susceptible species on the other hand. The conformity assessment procedure of TSE non-susceptible species differ from that of TSE-susceptible species in the way, that in the first case only the Notified Body is involved in the assessment procedure. There is no further exchange, as it is applicable in the second case with the Competent Authorities of other Member States required during the certification process. The EC conformity assessment procedures of devices utilising tissues of TSE susceptible species can be divided into the procedure with a TSE Certificate of Suitability issued by the European Directorate for the Quality of Medicines and HealthCare (EDQM) and the procedure without a TSE Certificate of Suitability. The difference between the two procedures is, that in case no EDQM certified starting material is used, the Notified Body is required to contact its national Competent Authority to obtain the opinions of the Competent Authorities of the other Member States. In the other case an exchange of information between the Notified Body and the national Competent Authority is suggested. Consultation procedures are also applicable for medical devices utilising animal tissues and incorporating an ancillary medicinal substance.

As a final conclusion the existing requirements and assessment procedures are considered as sufficient to ensure the safety of patients, users and contact persons during manufacture. Expertise concerning the evaluation of medical devices incorporating animal tissues was acquired by the Notified Bodies and the Member States during the last years and this expertise might contribute to the evaluation of the combination products of medical devices and advanced medicinal products at the Committee for Advanced Therapies (CAT).

Pages: 40