The Sterile Barrier Association (SBA) is a specialized trade association dedicated to maintaining and promoting product quality standards related to the manufacture and supply of single-use sterile barrier systems in the healthcare industry. Established with the primary purpose of acting as the European industry voice for sterile barrier systems, SBA provides a forum for manufacturers and service providers in this niche to discuss industry-relevant issues and coordinate responses to legislative measures that may impact the sector. The association aims to promote harmonization of standards, practices, and procedures relating to sterile barrier systems across Europe, while also seeking to extend this influence beyond European borders.
SBA’s lobbying activities center around key EU legislative frameworks affecting medical devices and packaging, notably the Medical Device Regulations and the Packaging and Packaging Waste Regulation, along with initiatives linked to the European Green Deal. The association engages with European and non-European regulatory bodies, trade associations, and users, cooperating as necessary to address common concerns. SBA is actively involved in consultation processes, position papers, and meetings with European Commission officials to influence legislative developments, especially in areas affecting sterile barrier systems’ compliance, safety, and environmental impact.
Operating since its registration on 15 March 2023, SBA’s head office is in the United Kingdom, with an EU office located in Finland. The association is classified as a trade and business association within the EU Transparency Register. It maintains an affiliation with MedTech Europe, leveraging this connection to enhance industry coordination and lobbying effectiveness.
Financially, SBA declared lobbying expenditures in the range of €50,000 to €99,999 for the calendar year 2023, funded entirely through membership subscription fees. Staffing for lobbying activities is relatively small, with two declared lobbyists equating to 0.5 full-time equivalents. SBA has no lobbyists accredited to the European Parliament but remains engaged through various communication activities and involvement in advisory groups, particularly on legislation related to the Green New Deal.
SBA’s strategic lobbying targets include promoting the harmonization of standards for sterile barrier systems, influencing packaging and medical device regulations to reflect the unique requirements of sterile barrier products, and ensuring that industry perspectives are included in the EU’s regulatory frameworks. Their approach includes working closely with key EU structures and participating in stakeholder consultations, webinars, and meetings to advocate for policies that support their members’ interests in product safety, quality, and environmental compliance.
