Legislative Information
At HARPS Global, regulatory compliance is fundamental to every product we deliver. Our solutions meet applicable requirements across global markets, ensuring reliable performance, accurate claims, and trusted quality.
ENSURING COMPLIANCE ACROSS PRODUCT CATEGORIES
At HARPS Global, our products may be regulated as medical devices, personal protective equipment (PPE), or both, depending on their intended use and market requirements.
Our teams continuously review applicable standards and regulatory frameworks to ensure full compliance with product classifications, performance requirements, and documentation obligations. This includes not only meeting regulatory expectations, but also ensuring that all product claims, certifications, and specifications are accurate and consistently validated.
When using a HARPS Global product, customers can rely on the fact that declared performance and compliance information are aligned with applicable regulations and verified through controlled processes.
ONGOING LEGISLATIVE MONITORING
As a global manufacturer, we actively monitor regulatory developments and assess their impact on our portfolio and customers.
Our experts are engaged in national and international standardization committees, including European bodies such as CEN, and participate in relevant industry associations such as Austromed and MARGMA. Through this involvement, we contribute to the development and continuous improvement of applicable standards and remain closely aligned with evolving regulatory expectations.
As a long-standing manufacturer with deep expertise in the field, we help ensure that product requirements and testing standards are designed to enhance safety, performance, and reliability. This includes active contribution to established standards such as the EN 455 series for medical gloves.
REGIONAL REGULATORY OVERSIGHT
HARPS Global products must meet the regulatory requirements set by national and international authorities in the markets where they are placed on the market.
In key regions such as the United States and the European Union, our products are subject to established regulatory frameworks. In the U.S., applicable products are regulated by the Food and Drug Administration (FDA) in accordance with relevant classifications and requirements (e.g. 21 CFR). In the EU, products must comply with the Medical Device Regulation (EU) 2017/745 and, where applicable, the PPE Regulation (EU) 2016/425, including CE marking obligations.
Our solutions are developed, manufactured, and tested in accordance with internationally recognized standards and regulatory frameworks, including:
- ASTM and EN performance standards
- European Medical Device Regulation (EU) 2017/745 and PPE Regulation (EU) 2016/425, including CE marking requirements
- U.S. Food and Drug Administration (FDA) requirements, where applicable
- ISO 13485 quality management systems for medical devices
- Occupational safety and chemical regulations (e.g. OSHA, REACH, Proposition 65)
REGIONAL REQUIREMENTS & REGULATORY UPDATES
This section highlights selected regulatory requirements and recent developments relevant to our products and markets. As regulatory frameworks continue to evolve, we provide updates on key topics to support transparency and informed decision-making.
Europe
REACH Regulation & Substances of Very High Concern (SVHC)
The European REACH Regulation (EC) No. 1907/2006 governs the registration, evaluation, authorization, and restriction of chemical substances within the EU, aiming to ensure a high level of protection for human health and the environment.
HARPS Global monitors the REACH Candidate List of Substances of Very High Concern (SVHC) and evaluates the potential presence of such substances in our products and packaging materials. Where applicable, we ensure compliance with communication and reporting obligations in accordance with REACH requirements.
To support transparency across the supply chain, HARPS Global provides a REACH declaration for its products. Registered distributors can access this documentation via the Distributor Portal.
EUDAMED Actor & Device Registration Requirements
Under the European Medical Device Regulation (EU) 2017/745, economic operators and medical devices must be registered in the European database on medical devices (EUDAMED), enhancing transparency and traceability across the EU market.
HARPS Global has completed actor registration for all relevant legal entities. Device registration for MDR-labeled products is being implemented in line with regulatory timelines and will be finalized no later than when registration obligations become mandatory on May 28, 2026.
Through these activities, we ensure continued compliance with EU requirements and support reliable market access for our products.
Further information is available on the official European Commission website.
PPWR
EU Packaging and Packaging Waste Regulation
The EU Packaging and Packaging Waste Regulation (PPWR) introduces a harmonized framework for packaging across the European Union, replacing the current Packaging Directive. It will apply from 12 August 2026, with further requirements phased in until 2030.
The regulation covers all packaging materials and levels, with the objective of reducing environmental impact through improved recyclability, reduction of unnecessary packaging, and harmonized requirements across the EU.
From 12 August 2026, packaging may only be placed on the EU market if supported by a Declaration of Conformity. Additional requirements include recyclability targets by 2030, harmonized labelling obligations expected from August 2028, and increased reporting and Extended Producer Responsibility obligations.
HARPS Global is actively monitoring these developments and has initiated internal activities to ensure timely and compliant implementation. Key focus areas include packaging material selection, design optimization, and the adaptation of documentation and compliance processes.
Where packaging forms part of a sterile barrier system, any potential changes are carefully managed under applicable medical device regulations, including validation and shelf-life considerations.
Further information is available on the official EU website.