News & Publications

Here you can find the more recent BTA activities, as well current developments in the field of blood transfusions. 

Securing Europe’s Health Future with a Safe Blood Supply

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…

Celebrating World Blood Donor Day: A Year of Progress and Safety

Today, June 14, we celebrate World Blood Donor Day, expressing our gratitude to all blood donors and highlighting the continuous need for donations.

BTA Welcomes SoHO Regulation Vote

The European Parliament adopts the Substances of Human Origin Regulation

Ensuring Patient Safety and Blood Supply: The EU Prolongs DEHP Sunset Date for Medical Devices

The European Commission extends DEHP Sunset Date for Medical Devices, a vital move for patient safety.

Celebrating World Blood Donor Day and Safeguarding the Future of Blood Supply

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…

Ensuring a Safe Blood Supply: BTA Publishes Position Paper on SoHO Regulation

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.  

Blood Transfusion Association: Enhancing Healthcare through Safe Blood Supply

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…

BTA Inaugural Event

BTA is excited to announce its first event

Fact Sheet on the Application for Authorisation (AfA) for the continued use of DEHP in blood bag sets

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…

BTA Statement on the proposal for an EU Regulation on Substances of Human Origin

The BTA welcomes the new proposal for an EU Regulation on Substances of Human Origin.

EXPANDING BTA’S MEMBERSHIP - WELCOME CERUS!

The BTA warmly welcomes Cerus, a new addition to the list of members forming part of the Association.

BVMed and SNITEM launch German-French initiative on MDR

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…

Relevant Parliamentary Questions answered in the first quarter of 2022

A summary of the most relevant parliamentary questions answered by the European Commission in the first quarter of 2022

The Commission releases its HERA Work Plan 2022

The new Commission's programm presents all activities of the newly created Commission body foreseen for 2022

ECDC publishes 2022-2024 programming document

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…

Publication of BTC Impact Assessment and Legislative Proposal officially delayed

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.

BTA's response to the publication of the MDCG classification guidance document

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.

Amendment to Annex XIV published

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.  

Commission publishes decision on classification of blood bag sets

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).

Delay in implementation of Medical Devices Regulation puts availability of blood bag sets at risk

The long-awaited MDCG classification guidance document under the new MDR is still to be published by the European Commission.

BTA responds to targeted stakeholder consultation on blood, tissues and cells legislation

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).

Upcoming classification guidance expected to impact blood bag sets

Under the new Medical Devices Regulation, blood bag sets might be up-classified from class IIb to class III.

BTA response to public consultation on the Inception Impact Assessment of the REACH regulation

The BTA submits a response to a public consultation on the Inception Impact Assessment (IIA) of the REACH regulation.

Public consultation to Annex XIV (REACH Regulation) concerning chemicals of very high concern

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.

Blood supply issues: a new work pillar for the BTA

In October 2020, the Commission set in stone its priority to revise of the EU legislation on blood, tissues and cells.

Expanding BTA’s membership - Welcome Hemanext!

The BTA is proud to announce that Hemanext will also be joining the association’s membership.

Expanding BTA’s membership - Welcome Grifols!

The BTA warmly welcomes Grifols, a new addition to the list of members forming part of the Association.

Over 20% of UK chemicals registrations to face revocation from April

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…

The BTA's Year in Review - 2020

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…

Inception Impact Assessment (IIA) on the EU’s blood, tissues and cells legislation

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…

EU4Health to tackle the impact of the pandemic

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.…

European Blood Alliance Calls for More Plasma

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…

BTA participation in EDQM webinar

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”…

NHSBT randomized study on convalescent plasma

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…

BTA participation in EDQM’s Blood Supply Contingency and Emergency Plan (B-SCEP) Group

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…

BTA's Position Paper on up-classification of blood bag sets

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…

Pan-European Commission on Health and Sustainable Development

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…

European Commission on Convalescent Plasma

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…

WHO guidance on blood supply safety during COVID-19

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,…

European Parliament's Committee meeting on the EU's upcoming Chemical Strategy

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…

EU Chemicals Strategy for Sustainability

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…

Non-DEPH | Leveraging BTA members' expertise

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,…

Delay in the Inception Impact Assessment on the EU’s blood, tissues and cells legislation

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…

European Commission’s guidance on convalescent COVID-19 plasma

On 8 April, the Commission released a guidance document on the collection and transfusion of convalescent COVID-19 plasma.

The Commission states that transfusion of convalescent plasma, as an…

EU MDR| Postponing of the date of application

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…

WHO's interim guidance on safe blood supply during the COVID-19 crisis

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…

ECDC's document on COVID-19 and supply of substances of human origin in the EU/EEA

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…

MDR: Global perspectives

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…

DEHP's toxicological profile available for Public Consultations

A toxicological profile on DEHP was published by USA Agency for Toxic Substances and Disease Registry (ATSDR)

BTA submitted a comment underlying that plastic blood bag sets containing DEHP were…

Building BTA Stakeholder Network

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…

BTA position papers on relevant topics

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…

Non-DEPH | Leveraging BTA members' expertise

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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