Work Package 1: Management of the action

The management of the action controls the quality and time lines of the activities to ensure that the action will be implemented as planned.

Work Package 2: Dissemination

To share the outcomes and deliverables with stakeholders, relevant institutions and organisations involved in the Joint Action.

Work Package 3: Evaluation

The aim of this work package is to verify if the action is being implemented as planned and reaches its’ objectives. Definition of how COENJA2014 will be measured and assessed, followed by active monitoring during the project through regular audits of COENJA2014 work packages and the compilation of reports.

Work Package 4: Development of a harmonized approach for checking the compliance of the information provided by the manufacturer to users regarding re-processing/re-sterilization

Work Package 4 is divided in two parts. Part one focuses on finding a strategy to identify the appropriate medical devices to be reviewed including the identification of the economic operators itself. Further on criteria have to be developed to select the appropriate economic operators.

Part two aims to verify the compliance of the information provided by the manufacturer with MDD and EN ISO 17664. Therefore a checklist has to be elaborated.

• Download the Instructions for use checklist.

Work Package 5: Development of a harmonized approach for checking the reprocessing validation data

In this work package a tool (questionnaire) has to be created on how to inspect the re-processing validation of the economic operators.

• Download the Checklist validation document.

Work Package 6: Collection and evaluation of data from the manufacturers

Work Package 6 focuses on the evaluation of the data obtained from the economic operators by the respective participating Member State. For this purpose the checklist (Work Package 4) has to be translated into the Member States’ national languages and sent out to the selected economic operators by each participating Member State. The data obtained have to be assessed by each partner. The output of this work package is a “Summary report about the evaluated responses”.

Work Package 7: Collection and evaluation of data from the manufacturers

The aim of Work Package 7 is to define on how to deal with non-compliancy and how to reach a uniform approach. To assure uniform understanding and to harmonize market surveillance activities, participating Member States (Market Surveillance Authorities) are trained and have the possibility to participate in joint inspections.