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Blood Transfusion Association

BTA

The Blood Transfusion Association is an international non-profit trade association founded with the objective to address the unique needs of the blood bag sets industry and will work together to ensure sufficient and safe supply of blood and blood components for transfusion to the patients in need.

Lobbying Activity

Response to EU rules on medical devices and in vitro diagnostics - targeted evaluation

21 Mar 2025

The BTA welcomes the ECs initiative to evaluate the EU regulatory framework for medical devices. While the MDR aims to ensure patient safety and high-quality healthcare, its current implementation presents significant challenges for blood bag sets, that are essential for safe blood collection, storage, and transfusion. The complexity, cost, and unpredictability of the MDR have created barriers that threaten both manufacturers and healthcare providers, ultimately putting patient care at risk. Blood bag sets are closed systems composed of one or more sterile containers made of plastic materials, commonly called the blood bag" and one or more tubes and attachments. Blood bag sets are well-established medical devices with a long history of safe use. However, the MDRs rigid requirements impose excessive regulatory burdens that delay approvals and increase costs. The limited capacity and slow designation process of Notified Bodies have created bottlenecks, resulting in significant delays for certification. Even for long-standing technologies like blood bag sets, manufacturers face prolonged approval timelines, making it difficult to maintain current products or introduce improved versions. Smaller manufacturers are particularly vulnerable to these challenges, as the high cost and administrative complexity of compliance threaten their ability to operate within the EU market. The MDRs strict conformity assessment and post-market surveillance requirements apply a one-size-fits-all approach that does not differentiate between well-characterized, mature devices and high-risk, innovative technologies. For blood bag sets, these additional regulatory layers do not necessarily enhance safety but instead create unnecessary administrative hurdles. The accumulation of overlapping requirements results in duplication of work, draining resources without clear benefits for patient safety or device performance. In many cases, manufacturers must invest heavily in compliance rather than in improving technologies or ensuring stable supply chains. Beyond regulatory burden, the MDR is also impacting market access and innovation. Some manufacturers are now deprioritizing the EU as a first-launch market due to the complexity and costs associated with compliance. This shift could lead to supply shortages, making it harder for hospitals and blood services to secure the necessary medical devices for transfusion procedures. Moreover, innovation in blood bag technology is being stifled, as companies face increased hurdles when introducing updates or improvements. The lack of flexible, risk-based pathways under MDR discourages advancements that could enhance efficiency, sustainability, and patient outcomes. The continued availability of blood bag sets is critical for European healthcare systems, yet the current regulatory framework risks disrupting supply chains. The administrative burden and delays in certification have created uncertainty, making it increasingly difficult for manufacturers to plan production and distribution. If these challenges are not addressed, the EU could face unintended consequences, including shortages of essential transfusion devices, ultimately affecting patient care and public health. To safeguard the supply of blood bag sets, targeted reforms to the MDR are necessary. Notified Bodies must be adequately resourced and made more efficient to reduce delays in conformity assessment. Policymakers should consider transition measures to ensure that existing devices remain available while regulatory improvements are implemented. The regulatory framework should foster, rather than hinder, innovation in blood bag technologies, ensuring that new developments can reach the market on time and sustainably. Without corrective action, the MDR may limit access to essential transfusion devices, risking patient safety. We are committed to collaborating with the EC and stakeholders to enhance regulations while safeguarding Europe's blood supply.
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Response to Critical Medicines Act

27 Feb 2025

The Blood Transfusion Association (BTA) welcomes the European Commissions initiative to strengthen the resilience of Critical Medicines supply chains in the EU. However, while ensuring pharmaceutical production and distribution is essential, the availability of medical devices required for the collection, processing, and administration of these medicines must also be safeguarded. Without measures for these technologies, Critical Medicines policies will be weakened, leaving healthcare systems vulnerable to disruptions. Medical devices are fundamental to ensuring the safety and availability of Critical Medicines. Technologies such as blood bag sets, plasmapheresis systems, and pathogen reduction systems are essential for life-saving treatments. However, the supply chains for these devices face similar vulnerabilities to pharmaceuticals, including reliance on third-country suppliers, disruptions in raw material availability, and insufficient manufacturing capacity within the EU. The Critical Medicines Act must explicitly integrate medical devices and develop strategies to support their production, procurement, and inclusion in emergency preparedness plans. A resilient Critical Medicines supply chain requires investment in medical technologies. EU industrial policy should prioritize dedicated funding for medical device manufacturers to reduce reliance on external suppliers and strengthen EU-based manufacturing. Public-private partnerships should be encouraged to expand production capacity, drive innovation, and improve technological resilience across the sector. Simultaneously, tailored impact assessments on critical medical devices are essential to ensure alignment across Europe and within the Critical Medicines Act, enabling informed stakeholder consultation and decision-making. Contingency planning must account for the limited stockpiling of medicines, making medical devices crucial. The Critical Medicines Act should support stockpiling devices, develop alternative storage solutions, and establish an EU-wide supply database to monitor levels and coordinate emergency responses. Additionally, a cross-border mechanism is needed for efficient distribution of medicines and technologies during crises. Public procurement policies must reflect the need for resilient medical devices alongside pharmaceuticals. The Critical Medicines Act should establish procurement frameworks that prioritize security, quality, and EU-based production, ensuring sustainable, long-term access to critical devices by focusing on quality and supply chain resilience over short-term cost savings. Long-term contracts should also stabilize demand and encourage sustainable EU manufacturing. At the same time, EU-based manufacturers face increasing competitive pressures from non-EU producers. The EU should introduce stronger trade defense mechanisms and align regulatory requirements for imported devices with EU standards to protect European manufacturers and maintain safety. The Critical Medicines Act must also take into account existing EU regulations, such as the Medical Devices Regulation (MDR) and REACH Regulation, which could restrict the materials necessary for producing critical medical devices. These regulations must be aligned to prevent conflicts that disrupt the supply chain. An effective Critical Medicines Act must recognize that securing pharmaceuticals alone is not enough. Medical devices must be integrated into policy measures, investment strategies, procurement rules, and contingency planning efforts. The Act should align with other EU regulations to ensure a cohesive approach to resilience. By prioritizing both medicines and medical technologies, the EU can build a stronger, more resilient healthcare supply chain. The Blood Transfusion Association and its members remain committed to working with EU policymakers to develop a robust strategy for Critical Medicines resilience.
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Response to Extension of the transition period for medical devices

18 Jan 2023

The Blood Transfusion Association (BTA) welcomes the Commissions recognition of the urgent risks of medical device shortages in Europe stemming from the challenges posed by the transitional provisions in the Medical Devices Regulation. The BTA is an international non-profit trade association comprised of manufacturers of blood collection and process sets and is dedicated to supporting the correct use and safe supply of blood for transfusion to ensure patient safety. The newly proposed transition periods open further possibilities for enhancing the notified bodies capacity, access to notified bodies and manufacturers preparedness, as well as avoiding potential shortages of medical devices. Likewise, the BTA aligns with the European Commissions proposal to delete the current sell-off date, as it contributes to avoiding a disruption of the supply of medical devices on the EU market, and prevents unnecessary disposal of safe medical devices that are already on the market but not yet with the patients that need them. It is also important to highlight that the extension of the MDD certificate would be associated with the absence of significant modification of the medical device. That requirement is to be placed in parallel with other regulations that are impacting the blood bags industry such as the EU 2021/2045 amending Annex XIV of the REACH regulation. In that sense, the extension provided on the Medical Device Regulation should also be aligned to the sunset date for DEHP in medical devices (REACH), according to recital 6 of 2021/2045, which states that regarding the use of DEHP in medical devices, the dates should also take into account the transitional provisions for the application of Regulations (EU) 2017/745 (medical devices) and (EU) 2017/746 (in vitro diagnostic medical devices) of the European Parliament and of the Council. This is necessary to alleviate the tremendous pressure placed on the supply chain/procurement in the global context, as well as to avert an insufficient supply of blood bags or similar devices in the near future. It is now of utmost importance that the European Parliament and Council adopt this legislative proposal as swiftly as possible to restore an acceptable transition period that allows the manufacturers to provide medical devices that ensure safety and availability to patients and healthcare systems. That initial step should initiate a more systemic approach to preventing the disruption of essential medical devices. The BTA members remain committed to complying with the Medical Devices Regulation.
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Meeting with Nathalie Colin-Oesterlé (Member of the European Parliament, Rapporteur)

7 Nov 2022 · SoHO regulation

Response to Revision of EU legislation on registration, evaluation, authorisation and restriction of chemicals

31 May 2021

The Blood Transfusion Association (BTA), an international non-profit trade association committed to promoting the correct use and safe supply of blood for transfusion, welcomes the opportunity to provide feedback on the IIA of the REACH regulation. Over the years, blood supply has been hampered by population ageing, climate change, and more recently, COVID-19, due to the decrease in blood donations. This demonstrates the importance of blood storage as a vital parameter to optimise blood supply and as such, a critical aspect of safeguarding public health. Blood bag sets with Di-2-ethylhexylphthalate (DEHP) have contributed to effectively storing blood, due to DEHP’s capacity of extending the storage life of red blood cells. However, recent developments have proposed sunsetting DEHP from medical devices on 27 May 2025, under the Annex XIV amendment of the REACH regulation. The BTA members are committed to identifying viable alternatives for developing new materials. There is however concern among key stakeholders – including blood establishments as well as the industry - that the timeframe for sunsetting DEHP use combined with the revision of the EU Blood legislation and the potential up-classification of blood bag sets under the Medical Devices Regulation (MDR) is untenable, and would drastically reduce the availability of blood bag sets. Blood bag sets are critical devices in the supply chain and are strictly regulated under multiple EU frameworks. Moreover, at a national level, certain countries also consider blood components as medicinal products, and are further regulated by corresponding pharmaceutical legislations. The implementation and roll out process of a new material is a lengthy process which can only start once the CE mark has been granted to the manufacturers. This CE marking also means that national bodies and blood establishments will either review the new specifications or carry out their own studies before releasing the new product. The introduction of a novel material would not only require comprehensive development efforts but also significant qualification and validation work. Therefore, substituting DEHP in blood bag sets is expected to take 6-9 years to cover the development, CE marking under MDR and the roll out into the marketplace – without taking into account the potential up-classification of blood bag sets. The application for authorisation (AfA) process foreseen within the REACH regulation does provide a tool to extend the use of DEHP, but as the IIA correctly noted, the process is highly cumbersome and costly, and introduces uncertainty on the availability of blood bag sets after the sunset date. In the interim, the BTA also appeals to the Commission to consider extending the essential use concept to DEHP with respect to its role in the maintaining blood supplies, and the current lack of feasible alternatives. As previously mentioned, DEHP’s capacity to extend blood storage in an already limited blood reserve helps in sustaining blood supply, thus benefitting public health. Moreover, although potential alternatives to DEHP are already under investigation, existing data demonstrate that their blood storage properties do not match up to those of DEHP and their effects remain poorly understood. Therefore, by operationalising the essential use concept for DEHP until 2027-2030, blood supply and patient safety would be safeguarded. In light of the above, concern about the envisaged timelines, BTA would like to work together with the Commission and other key stakeholders to find solutions to these pressing issues and ensure continuous blood supply across the EU. As stated in a previous consultation, BTA recommends that the phasing-out of DEHP in blood bag sets is scheduled for 2027-2030, a timeline broadly accepted by both industry and blood establishments. A joint and strong commitment to this timeframe would facilitate the transition of non-DEHP blood bag sets without compromising patient safety.
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Response to Commission Regulation amending Annex XIV to REACH

5 Jan 2021

The Blood Transfusion Association (BTA) welcomes the opportunity to provide feedback on the draft Commission’s Regulation amending Annex XIV to the REACH Regulation. The BTA is an international non-profit trade association dedicated to supporting the correct use and safe supply of blood for transfusion to ensure patient safety. Population ageing, climate change, and more recently the COVID-19 pandemic have all had a direct impact on the volume of blood donations. In this context, blood storage becomes a critical parameter to optimise blood supply and as such, should be thoroughly considered in the development of the amendment to Annex XIV. Blood bag sets contain Di-2-ethylhexylphthalate (DEHP) which is subject to the present amendment. DEHP is known to have positive effects on the storage of red blood cells. Although the BTA members are committed to identifying viable alternatives for developing new materials, they are concerned that the envisaged timeframe for sunsetting the use of DEHP combined with the revision of the EU Blood legislation and the potential change in the classification of blood bag sets under the Medical Devices Regulation (MDR) would greatly hamper the availability of blood bag sets across the EU. Blood bag sets are critical devices in the blood supply chain which are subject to multiple legislative and regulatory frameworks on International, European and national levels. As medical devices, blood bag sets fall within the scope of the MDR. The use of blood bag sets for the collection of blood is regulated by the Blood Directive which is expected to be reviewed in the coming year. In addition to these legal frameworks, in some countries (e.g. Germany, France), blood bag sets become medicinal products as soon as they are blood-filled and further processed, and consequently become subject to the corresponding pharmaceutical legislation. Furthermore, the European Pharmacopeia and ISO 3826 on plastic collapsible containers for human blood and blood components also apply to blood bag sets. The implementation and roll out process of a new material is a lengthy and complex process. The implementation can only start once the CE mark has been granted to the manufacturers. As a following step, for many Member States this CE marking means that national bodies like e.g. the Paul Ehrlich Institute (PEI) in Germany or the ANSM in France will either review the new specifications or carry out their own studies before releasing the new product for use within their markets. As a consecutive step, blood establishments will have to conduct their own studies including a storage study for red blood cells as part of their pharmaceutical production process. The aim of this study is to prove that the quality of the non-DEHP product is at least as good as the DEHP product. Blood establishments across the EU would therefore need time to qualify a new blood bag set material and experience has shown that more than one year would be required in some Member States e.g. France. This whole process including development, CE marking under MDR and the roll out into the marketplace is expected to take 6-10 years without taking into account a potential future up-classification of blood bag sets from class IIb to class III. The BTA is therefore concerned about the envisaged timelines and calls on the Commission to review those timelines based on the above considerations to ensure continuous blood supply across the EU. The introduction of a novel material would not only require comprehensive development efforts but also significant qualification and validation work e.g. biocompatibility testing, stability and functional testing, potential clinical studies. In this context, the BTA recommends scheduling the phasing-out of DEHP in blood bag sets provided for in the draft Commission’s Regulation for 2027-2030, in line with the 6-10-year process mentioned above.
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Response to Revision of the Union legislation on blood, tissues and cells

14 Dec 2020

The Blood Transfusion Association (BTA) welcomes the European Commission’s Inception Impact Assessment (IIA) on the revision of the blood, tissues and cells (BTC) legislation and the opportunity to provide feedback. The BTA is an international non-profit trade association dedicated to supporting the correct use and safe supply of blood for transfusion to ensure patient safety. As an integral part of modern medicine, blood transfusions are used in a wide range of treatments that are often lifesaving. Blood donors are vital for saving the lives of patients who need transfusions or blood- or blood component-based therapies. However, current changes in Europe have directly impacted blood supply, such as population ageing, climate change, and more recently the COVID-19 pandemic which have resulted in a decrease in blood donations due to lockdowns or deferrals. Hence, blood storage becomes a critical parameter to optimise blood supply and as such, should be considered as part of the Impact Assessment. In this context, we support the claim made in the IIA that “BTC donations should be used for optimal patient benefit, while enabling the sustainability of health services organising the service chain from collection, testing, processing, storage and distribution to recipient follow-up, whether they are public or private. Substances of human origin are not to be considered commodities.” Blood bag sets are critical devices in the blood supply chain which are subject to a complex regulatory framework. While blood bag sets are considered medical devices, falling within the scope of the EU Medical Devices legislation, their use for the collection of blood and blood components is regulated by the EU Blood legislation. In this context, a potential revision of the EU BTC legislation may have an impact on the process of validation of these devices which can take up to 18-24 months in some Member States. Additionally, blood bag sets contain Di-2-ethylhexylphthalate (DEHP), a plasticizer known to have positive effects on the storage of red blood cells. This substance is listed as an endocrine disruptor, and as such, the European Commission recently published a draft Regulation removing the exemption from Authorisation for the use of DEHP in medical devices, including blood bag sets. Although the BTA members are committed to identifying viable alternatives for developing new materials, they are concerned that the envisaged timeframe for sunsetting the use of DEHP together with the revision of the EU BTC legislation would hamper the availability of blood bag sets across the EU. Any changes in the use of blood bag sets for the collection of blood and blood components combined with changes of materials may therefore have an impact on the continuity of blood supply in the EU. The BTA further takes note of the three policy options that will be assessed during the Impact Assessment and considers it crucial that all stakeholders, including blood bag set manufacturers, be involved in the definition of the technical rules and specifications that will be defined, no matter what policy option is identified as the best way forward following the Impact Assessment. In addition, those technical rules and specifications should contribute to ensuring greater harmonisation and standardisation across the EU while supporting innovation such as automation of blood collection and processing. Automated blood manufacturing has many advantages over manual or semi-automated production, including better consistency of blood product quality and occupational safety. Technologies with the highest level of automation would help achieve greater blood and patient safety across the EU. The BTA calls on the Commission to take the above considerations into account as part of the development of the Impact Assessment and looks forward to contributing to the thorough stakeholder consultation process outlined in the IIA.
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Response to Chemicals strategy for sustainability

19 Jun 2020

The Blood Transfusion Association (BTA) welcomes the Commission’s Roadmap and the opportunity to provide feedback. As rightly pointed out in the Roadmap, "Chemicals […] are crucial for many manufacturing industries - such as pharmaceuticals, medical equipment […]." The blood bag set industry is no exception. Blood bag sets contain Di-2-ethylhexylphthalate (DEHP), a plasticizer known to have positive effects on the storage of blood components. The European Chemicals Agency (ECHA) recommends removing the exemption from Authorisation for the use of DEHP in medical devices, including blood bag sets. However, there are currently no alternative substances that meet the quality standards of DEHP. Although the BTA members are committed to identifying viable alternatives, they are concerned that the envisaged timeframe for sunsetting the use of DEHP would hamper the availability of blood bag sets across the EU, and therefore public health. This should be taken into consideration, particularly given the Chemical Strategy’s aim to improve protection of citizens and the environment against hazardous chemicals and encourage the innovation of safe and sustainable alternatives. It should also be noted that Annex XIV to the REACH Regulation (so called “Authorisation List”) creates a distortion on the EU market and places manufacturers outside the EU in an advantageous position. This goes against the Chemical Strategy’s goal to support the EU’s autonomy in the production of essential chemicals across key sectors. EU manufacturers are bound by Annex XIV, whereas manufacturers outside the EU can continue to place their goods containing the substance, preparation or article, on the EU market. This causes a shift of production from the EU to non-EU countries while defeating the purpose of increasing the safety of products within the EU. The use of blood bag sets for the collection of donor blood is strictly regulated. Blood bag sets are considered as “medical devices”, falling within the scope of the European legislation on Medical Devices (see Regulation (EU) 2017/745). The use of blood bag sets for the collection of blood is also regulated by the Blood Directive (see Directive 2002/98/EC). In some Member States blood and blood components are considered as medicines and thus blood bag sets become subject to the corresponding pharmaceutical regulations (see Directive 2001/83/EC) as soon as they are filled with blood or blood components. Furthermore, the medical device legislation provides a high level of safety when it comes to the use of chemicals: the Commission itself has indicated that the level of protection of human health provided by the Medical Device Regulation is comparable with that afforded by the REACH Regulation. Current changes in Europe have directly impacted blood supply in the EU, such as an ageing population, climate change, and more recently the COVID-19 pandemic have resulted in a decrease in donations. Thus, blood storage becomes a critical parameter to optimise blood supply. Studies have demonstrated that DEHP extends the shelf life of the stored red blood cells up to 49 days. At this moment, no viable alternative for DEHP would grant the same benefits in terms of storage. It is therefore crucial that time is granted to further research alternative substances and collect sufficient data. Such an alternative would have to obtain the same results in terms of shelf life, low levels of haemolysis and discarding of blood units. Provided no alternative is identified, sunsetting the use of DEHP in blood bag sets will pose significant challenges to the availability of blood.
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