3rd Health Programme (2014-2020)
Market surveillance of medical devices [JAMS]
This Joint Action aims to reinforce market surveillance between Member States. Best practice, training, knowledge and resource will be shared to increase public health protection in the medical device...
This Joint Action aims to reinforce market surveillance between Member States. Best practice, training, knowledge and resource will be shared to increase public health protection in the medical devices sector. A key aim is to improve coordination and help lower-resourced Member States develop skills and capacity in the market surveillance network. It will help to ensure consistent and proportionate approach across all Member States in manufacturer inspections and clinical process and resource development.
Methods will be developed as follows:
1. Manufacturer inspections:
• Develop methods, agreed tools and guidance’s for a joint, consistent and proactive approach
• Establish specific inspection scopes and objectives to complement those conducted by conformity assessment bodies
• Develop different approaches and focus to manufacturer inspections
• Develop and deliver collaborating mechanisms designed to maximize the efficiency and effectiveness of resource deployment
• Develop an inspector training course to provide inspectors with basic skills and establish an inspectors expert group for ongoing collaborative approaches
2. Clinical process and resource development:
• Establish communication platforms and protocols
• Establish current practices and identify development and/or training needs and evaluation of clinical data by authorities
• Identify and prioritise medical devices which require development of common specifications to define clinical criteria for safety and performance.
In harmonising the European market surveillance system detection and reduction in the occurrence of safety issues will lead to increased public health protection by ensuring that medical devices conform especially to the requirements relating to safety and performance.
Start date: 17/10/2016 - End date: 16/01/2020
Call: Health Programme Adhoc Call for invited (named) beneficiaries