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3rd Health Programme (2014-2020)
Joint Market Surveillance Actions on medical devices intended to be re-sterilized focusing on information in the Instruction for use and validation data necessary for the re-sterilisation by the user [COENJA2014]
Member states (MS) are reinforcing their market surveillance of medical devices, in particular by improving their coordination, i.e. for performing a joint market surveillance action including appropr...
Member states (MS) are reinforcing their market surveillance of medical devices, in particular by improving their coordination, i.e. for performing a joint market surveillance action including appropriate checks on the characteristics of products placed in the European Market. This joint action (JA) includes further development and expanding the coordination between MS, joint inspections by the Competent Authorities (CAs) shall be part of the project.
This Joint Action of European CAs will improve the transparency in the medical device market regarding compliance of medical devices to be reprocessed. It shall be investigated if the instruction for use (IFU) of medical devices intended to be re-used and resterilized conforms and contains all necessary information for safe and adequate re-processing. This will also allow an actual overview of the market related to these products and detecting deficiencies regarding re-processing posing a serious hazard to safety.
The market surveillance JA also contains additional elements, besides review of the IFU and sections of the technical documentation, such as inspections of manufacturers and other relevant actors. The outcome may also result in joint enforcement actions by the respective MS to be coordinated if needed and adequate. Meetings shall support harmonizing the processes to achieve a uniform action and to discuss and publish the final report.

Start date: 01/11/2015 - End date: 30/04/2017

Call: Grants for actions co-financed with Member State authorities 2014 (Joint Actions)
Topic: 3.1 Support voluntary cooperation between Member States on health technology assessment under the network on health technology assessment set up by Directive 2011/24/EU. Facilitate ...
Topic: 3.1 Support voluntary cooperation between Member States on health technology assessment under the network on health technology assessment set up by Directive 2011/24/EU. Facilitate the uptake of the results streaming from research projects supported under the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007-2013), adopted by Decision No 1982/2006/EC of the European Parliament and of the CouncilĀ (1), and, in the long term, the activities which will be undertaken in the Framework Programme for Research and Innovation (Horizon 2020).
3rd Health Programme (2014-2020)
Vigiliance and Inspection for the Safety of Transfusion, Assisted Reproduction and Transplantation [VISTART]
The aim of this Action is to support EU Member States (MS) in developing and strengthening their capacity for monitoring and control in the field of blood transfusion and tissue and cell transplantati...
The aim of this Action is to support EU Member States (MS) in developing and strengthening their capacity for monitoring and control in the field of blood transfusion and tissue and cell transplantation. 7 core work-packages (WP) have been defined. WP4 will explore commonalities between vigilance reporting in these fields, identifying opportunities for harmonising procedures. WP5 will increase the sharing of vigilance information of didactic value in order to achieve higher standards of quality and safety across blood, tissues and cells, as well as defining regulatory principles for short and long term follow up of recipients of blood, tissues and cells that have been prepared with newly developed and validated processes. WP6 will focus on the development of common Inspection Guidelines for EU Competent Authorities responsible for the inspection and authorization of blood and tissue establishments. The main objective is the identification of a common framework for the conduct of inspections of blood and tissue establishments, developing a common approach with sharing of procedures across MS. The educational profile, basic competencies and specific skills required by MS for the respective inspectors in these fields will be defined in WP7. This action will include a number of initiatives aimed at increasing the interaction between inspectors from different MS including inspector training, a framework for joint inspections by multi-MS teams (WP8), a pilot for regional inspections and the creation of an inter-MS (WP9) inspection system auditing programme. The impact of these activities will be greatly increased by virtue of their conduct across the fields of blood, tissues and cells and ART. Greater inter-MS circulation of tissues and cells will also be facilitated by this action through support for the harmonised implementation of the Single European Code (WP10) and its associated compendia of tissue establishments and tissue and cell products.
Start date: 10/10/2015 - End date: 09/02/2019

Call: Grants for actions co-financed with Member State authorities 2014 (Joint Actions)
Topic: 4.5 Actions required by, or contributing to, the implementation of Union legislation in the fields of human tissues and cells, blood, human organs, medical devices, medicinal produc...
Topic: 4.5 Actions required by, or contributing to, the implementation of Union legislation in the fields of human tissues and cells, blood, human organs, medical devices, medicinal products, and patients' rights in cross-border healthcare, while fully respecting the competences and ethical choices of Member States in those fields. Such action may include activities aimed at facilitating the implementation, application, monitoring and review of that legislation.