Understand more about Work Packages
The Joint Action for Market Surveillance of Medical Devices (JAMS) is being delivered through five Work Packages, each tasked with delivering a variety of outcomes to meet the objective of this Joint Action.
Work packages 1-3: Coordination, dissemination and evaluation
The National Agency for the Safety of Medicines and Health Products (ANSM) in France is responsible for the first three work packages:
- Coordination of the project: ANSM has to verify that the Joint Action is completed on time, within budget, and with high–quality deliverables
- Dissemination of the information: ANSM has to collect and circulate the deliverables to the target groups
- Evaluation: ANSM has to check that the implementation of the project is developed as planned.
Work package 4: Joint Manufacturer Inspections
As part of their work package to improve manufacturer inspections, ANSM (France) and the National Authority of Medicines and Health Products (INFARMED) in Portugal, in collaboration with European partners, are responsibles for:
- Developing methods, agreed tools and guidance for a joint, consistent and proactive approach to manufacturer inspections by competent authorities: At the beginning of the project, it is expected to identify various approaches and differences between Competent Authorities as how they approach market surveillance. A guidance document intended to define and specify good practice by sharing and exchanging information on performing inspections will be developed.
- Establishing specific inspection scopes and objectives to complement those conducted by conformity assessment bodies:The joint manufacturer inspections will be complementary to the existing system in order to reinforce the current performances and permit the harmonisation of joint manufacturer inspections and not current national manufacturer inspections. Work package 4 will develop a harmonised guidance regarding joint inspection planning strategies.
- Identification of sources of information to be used to focus on during the Joint inspections to achieve maximum public health impact: An inspector training course will be developed to prepare inspectors to perform intended joint inspections and to perform inspection according to the joint approach.
- Developing and delivering collaborating mechanisms designed to maximise the efficiency and effectiveness of resource deployment: Competent Authorities will initiate a joint manufacturer inspection regime to reinforce market surveillance.
Work package 5: Clinical process and resource development
As part of their work package to improve clinical process and resource development, the Health Products Regulatory Authority (HPRA) in Ireland is coordinating the following:
- The identification and establishment of communication platforms and protocols: A communication platform will allow Competent Authorities the opportunity to discuss market surveillance issues in particular in the clinical arena that affect some or all European Competent Authorities in real time and provide a platform to discuss specific market surveillance issues in a confidential setting.
- Establish current practices and identify development and/or training needs in the evaluation of clinical data by authorities: Based on the findings from workshops and surveys, a training strategy will be defined. Training material will be developed to provide practical guidance on the assessment and review of clinical data as part of market surveillance activities.
- Identify and prioritise medical devices which require development of common specifications to define clinical criteria for safety and performance: Under the new proposals for a regulation on medical devices and in vitro diagnostic medical devices, common specifications will be developed addressing the clinical requirements for safety and performance. The work of the joint action will help identify the priorities for developing common specifications and help inform the activities for implementing the new regulations.