Legal Manufacturer & EU Representative

Legal Manufacturer & EU Representative

Regulatory Affairs, Regulatory Certifications

Information

We assume regulatory responsibility as Legal Manufacturer and EU Authorized Representative (EU-Rep) – for both EU and non-EU companies. As an outsourced manufacturer, we represent you in full compliance with the MDR, take on the obligations of placing products on the market, and thus ensure your access to the European market. Our service includes: Official role as Legal Manufacturer in accordance with the MDR EU-Rep function for non-EU manufacturers Responsibility for conformity, technical documentation, and communication with authorities Support with product registration and EUDAMED entries Long-term support including market surveillance & vigilance  You save resources, avoid risks, and gain an experienced, competent partner with clear responsibilities and reliable implementation.
Bytec Legal Manufacturer GmbHS9.C96BYTEC Legal Manufacturer GmbH is a young, dynamic company based in Germany with an international outlook. As a subsidiary of BYTEC Medizintechnik GmbH, our established parent company and ODM for medical devices with core competencies in production, SW & HW and system development, we combine long-standing industry experience with a forward-thinking, hands-on approach. BYTEC Legal Manufacturer GmbH specializes in development, regulatory affairs, and quality management consulting, including QMB and PRRC services, supporting sustainable market access, medical technology diversity, and better patient care. As your legal manufacturer, we take responsibility for regulatory approvals, market access, documentation, and quality management to ensure MDR compliance, so you can focus on your core business. Your brand remains fully yours, and we appear only in small print on the device label. As your EU representative, we support non-European manufacturers in placing products on the European market efficiently and in full regulatory compliance. Your added value: quality, reliability, and foresight.

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