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SBS Forum 2022 on PPE and Textile Care
Standardisation in the PPE sector – From dual use to multi-use
19 October, 10:00 - 13:00 (online)
The European Commission’s vision for leadership in digital transformation and green transition (twin transition) is reflected its legal proposals either as new legislation proposals or revision of existing legislations, such as the AI ACT, the Data ACT, eIDAS 2.0, the Sustainable Product Initiative, including the Digital Product Passport, the sustainable textile strategy, and the Ecodesign directive.
At the heart of these proposals, there is an emphasis on the role of standardisation and compliance with harmonised standards to achieve EU Single Market integration and impose European core values at global markets. The relationship between green transition and digital transformation is further explained through the digital product passport, and the several sustainable digitalisation initiatives such as the Green Digital Coalition.
However, while SMEs are actively supportive of the EU’s vision, the complexity of standardisation is worrying to some degree. Compliance costs are likely to rise due to the different compliance requirements for PPE manufacturers and service providers. In addition, the degree of complexity is increasing, and the level of skills and technical know-how needs to be upgraded. For example, a smart textile that has an embedded AI chip and is capable to connect to the Internet (i.e., an IoT device) has to comply with the AI ACT and the Radio Equipment Directive (RED), including but not limited to cybersecurity, data exchanges, and ethical AI standards. In addition, the PPE and/or medical devices regulation might have to be followed. If an eco-design directive should be implemented the provision of services and the placing of new products onto the market becomes even more complex.
SMEs concern is twofold:
- Compliance costs and complexity: PPE and textile SMEs find themselves in a delicate situation, where they need to comply with different legislations that were previously irrelevant to their core business. This adds confusion to the already existing issues in the industry such as the issue of the dual use (i.e., a PPE device that is also considered a medical device), where a life jacket can also be defined as a RED device.
- Skills levels: The majority of SMEs and PPE standardisation experts need to upgrade their digital skills and green knowledge to incorporate these new requirements into standardisation. As acknowledged during the CEN-CENELEC workshop on “Smart PPE – standardization for design and use”, this is not only a concern for SMEs, and experts, but also for the notified bodies who must have an adequate skills level to be able to execute performance tests and declare conformity accordingly!
Would EU legislations aiming at digitalising and greening European industry prove too costly and too complex for an SME driven economy, or will this be an opportunity for European enterprises to differentiate their products and services and emerge as strong global player? How can standards help SMEs to integrate green and digital aspects into their production processes to offer differentiated products and services?
The SBS PPE and Textile Care Forum 2022 brings together policy makers, standardisation experts and SMEs to discuss and debate on the issue above.