GAPP Joint Action (facilitatinG the Authorisation of Preparation Process for blood and tissues and cells) is a 36 months JA aiming at facilitating the development of a common and optimal approach to assess and authorise preparation processes in blood and tissues establishments (BEs and TEs). Particular attention will be devoted to innovative processes that might come up taking advantage of the work developed in previous EU funded projects/actions. This Joint Action will clearly contribute to the implementation of Union legislation in the fields of human tissues and cells, blood, providing tools and training to increase harmonisation of those MS activities that regulate the areas of blood transfusion, transplantation of tissues and cells and assisted reproduction, in strong abidance with art 4.5 of Annex I of Regulation 282/2014. These are fields of healthcare that involve a considerable amount of movement of donated substances of human origin between MS and also movement of citizens between MS for treatment, particularly in the field of assisted reproduction. The aim of the action is to prepare a “Good Practice Guidelines to authorisation and preparation process in blood, tissues and cells” and its three technical annexes respectively on i) authorisation changes in donation, procurement and collection, processing, preservation, storage and distribution (divided in three part blood, tissues and cells, and reproductive tissues and cells); ii) assessing the quality and safety of donor testing, microbial inactivation and sterilisation steps as part of PPA; iii) assessing clinical data as part of PPA. In addition to this it will be built a model and a tool to facilitate sharing of information among European Union Competent Authorities and a number of CA inspectors will be trained specifically to assess and authorise preparation processes of tissues, cells, reproductive cells and blood products.
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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.

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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.


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