Seminar CL2 – Medical device vigilance

 

Medical devices (MDs) are an essential part of the delivery of high quality healthcare and their procurement and management in the European hospital setting is often under the authority of hospital pharmacists. They constitute a broad range of products, ranging from very simple and safe products to invasive, complex, and high sophisticated technologies.

 

Systems for pharmacovigilance reporting by health professionals in respect of medicines are well established across Europe; legislation and practice is not so standardized and spread for MDs. On the other hand, the approval and marketing process for MDs at the present moment does not require clinical trials to be performed for all MDs classes.

 

In this context, high risk medical devices are put on the market, and there is the need of a structured process for medical devices vigilance. Europe is currently revising legislation on MDs, putting more focus also on this matter. Hospital pharmacists may play a pivotal role in medical device vigilance, supporting clinicians and nurses. The seminar will address the process of medical device vigilance in those countries where a clear procedure is defined, and will point out the open questions that still need to be covered at a legislation point.

 

 

• To describe the process of risk assessment of medical devices in the premarketing phase;

• To describe the process of medical devices vigilance after their market access;

• To contrast the strengths and weaknesses of the actual MDs vigilance system.

 

 

After the presentation the participant should be able:

 

• to recognise MDs by different risk levels;

• to be aware of the process of risk assessment of MDs before marketing;

• to outline medical device vigilance and be able to transfer the model to their environment.