Division 1.2 Process of risk assessment

In order to ensure a high level of protection for patients and users, the manufacturer of devices utilising animal tissues or derivatives referred to in point 1.1 must implement an appropriate and well documented risk analysis and risk management strategy, to address all relevant aspects relating to TSE. He must identify the hazards and evaluate the risks associated with those tissues or derivatives, establish documentation on measures taken to minimise the risk of transmission and demonstrate the acceptability of the residual risk associated with the device utilising such tissues or derivatives, taking into account the intended use and the benefit of the device.

The safety of a device, in terms of its potential for passing on a TSE infectious agent, is dependent on all the factors described in sections 1.2.1 to 1.2.8, which the manufacturer must analyse, evaluate and manage. These measures in combination determine the device safety.

At a minimum, the manufacturer must consider the following key steps:

1. (a)

   selecting starting materials (tissues or derivatives) considered appropriate regarding their potential contamination with TSE infectious agents (see 1.2.1, 1.2.2, 1.2.3 and 1.2.4) taking into account further collection, handling, transport, storage and processing;

2. (b)

   applying a production process to remove or inactivate TSE infectious agents on controlled sourced tissues or derivatives (see 1.2.5);

3. (c)

   maintaining a system to collect and evaluate production and post-production information regarding changes which may affect the assessment of the suitability of steps referred to in points (a) and (b).

Furthermore, the manufacturer must take into account the characteristics of the device and its intended use (see 1.2.6, 1.2.7 and 1.2.8).

In performing the risk analysis and risk management strategy, the manufacturer must give due consideration to the relevant published opinions adopted by the relevant F1international scientific committees or bodies.