Discover how recent regulatory advancements are shaping the future of Europe's blood supply, ensuring safety, sustainability, and preparedness in our latest article published in Open Access…
Today, June 14, we celebrate World Blood Donor Day, an important occasion to express gratitude to all blood donors. This day also highlights the ongoing need for blood donations to ensure a safe and…
The Blood Transfusion Association (BTA) is pleased to announce the release of its position paper on the Proposal for Substances of Human Origin (SoHO) Regulation.
Discover how the BTA, is working to advance the safe supply of blood for transfusion. Through collaboration and coordination with stakeholders, advocacy and representation in policymaking, and…
The BTA has developed a fact sheet on the Application for Authorisation (AfA) for the continued use of DEHP in blood bag sets. The fact sheet provides an informative and simple explanation of the…
The German Federal Association of Medical Technology (BVMed) and the French "Syndicat National de l'Industrie des Technologies Médicales" (SNITEM) are calling for a rapid expansion of the capacities…
The 2022-2024 programming document that responds to the continued need to support the European Commission and the Member States in their response to the COVID-19 pandemic while realising the…
The publication of the Impact Assessment and Legislative Proposal on the revised blood, tissues and cells (BTC) legislation is now confirmed to be published in Q1 2022.
In BTA's view, the classification guidance document still leaves room for interpretation as to how blood bag sets containing citrate-based anticoagulant solutions should be classified.
The publication of the amendment to Annex XIV of REACH sets in stone the proposed sunset date for removing products containing DEHP from the EU market.
On 4 October, the Medical Device Coordination Group (MDCG) published the long-awaited guidance document on classification of medical devices under the new Medical Device Regulation (MDR).
On 23 July, the BTA submitted a response to the targeted stakeholder consultation on the revision of the EU legislation on blood, tissues and cells (BTC).
Originally published in 2016, the REACH Regulation regulates the use of chemicals across the EU in all industries in order to improve human health and the environment.
The United Kingdom (UK) and the European Union (EU)’s chemical industries are currently heavily intertwined. Given the UK’s exit of the EU, measures are needed to ensure that the UK has a chemical…
As a new association, 2020 has been an interesting year for the BTA. From creating our visual identity, to establishing a wide network in the blood transfusion area, we explore some of our key…
The European Commission published the Inception Impact Assessment (IIA) on the revision of the Blood, Tissues and Cells (BTC) legislation on 17 November 2020. This was open for feedback until 14…
On 10 November the European Commission welcomed the agreement between the European Parliament and EU Member States in the Council on Europe's next long-term budget for 2021-2027, including EU4Health.…
The need to increase supply of blood products such as plasma has been brought to the forefront in view of the COVID-19 pandemic, both as a potential therapy to the Sars-CoV-2 virus and to enable…
The Council of Europe - European Directorate for the Quality of Medicines (EDQM) held a three-day webinar entitled “Keeping up with Reality and Quality: A Challenge for European Blood Establishments”…
The NHS Blood and Transplant is (NHSBT) announced on 19 October the opening of 14 more blood plasma donation centres. The opening of these centres will improve access by potential donors. The NHS…
The BTA has successfully joined the European Directorate for the Quality of Medicines (EDQM) group working on a Blood Supply Contingency and Emergency Plan (B-SCEP). The overall objective of the…
The proposed up-classification of blood bag sets under the new Medical Devices Regulation (MDR) from class IIb to class III due to misalignment on the interpretation of the changes in the…
A Pan-European Commission on Health and Sustainable Development was convened in August by the World Health Organisation (WHO)’s Regional Office for Europe. This Commission will revisit policy…
The BTA was approached by the European Commission to provide information regarding the member’s activities within the field of plasma collection. On 31 July the European Commission announced the…
The World Health Organisation (WHO) published an interim guidance on maintaining a safe and adequate blood supply during the COVID-19 crisis. The document provides recommendations on donor deferral,…
The Environment, Public Health and Food Safety Committee (ENVI) of the European Parliament adopted a resolution calling on the European Commission to minimise the exposure to hazardous chemicals…
The European Commission published its Roadmap on the Chemicals Strategy on Sustainability on 9 May. The Roadmap was open for feedback until 20 June. The Commission believes that the current COVID-19…
The BTA's Working Group has been working to develop a common approach to the Benefit-Risk Assessment for the justification of the use of phthalates in medical devices. Several meetings have been held,…
The launch of the Inception Impact Assessments (IIA) for the revision of the EU Blood, Tissues, and Cells legislation has been delayed due to COVID-19. An IIA is the Commission's initial analysis of a…
The European Commission announced on 25 March 2020 the intent to postpone the implementation of the new MDR for 1 year. The official proposal was published on 3 April. The announcement follows the…
Availability of blood component is at risk due to decrease in numbers of donations. US, the biggest exporter of blood components, is facing the highest increase of COVID-19 infections globally. The…
The European Centre for Disease Prevention and Control (ECDC) has published a document to mitigate the risks of Covid-19 impacting safe and sustainable supply of substances of human origin (SoHO). The…
The World Trade Organisation (WTO) held a Thematic Session on Good Regulatory Practice in Geneva on 25 February 2020, with two panels, one of which on Medical Devices. Representatives of agencies from…
The BTA has been extending its network and connections within the blood transfusion sector. It has established collaboration with the European Blood Alliance (EBA). The BTA has also held meetings with…
The BTA has developed two position papers. The first underlies the concern of BTA members that the envisaged timeframe for sunsetting the use of DEHP would hamper the availability of blood bag sets…
A Working Group with scientific experts from member companies has been created. The group's objective is to develop a common approach to the Benefit-Risk Assessment for the justification of the use of…
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