Definition: As Assessors of Technical Documentation, we evaluate and verify the regulatory documentation required for EU market access, ensuring it meets the specific standards for each product category. This includes technical files, safety reports, and compliance dossiers critical for CE marking or market notifications.
Scope and Relevance:
For Medical Devices and In Vitro Diagnostic Medical Devices (IVDs), we assess technical documentation under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), ensuring compliance with Annexes II and III (e.g., risk management, clinical evaluation, performance data).
For Cosmetics, we review Product Information Files (PIF) and Cosmetic Product Safety Reports (CPSR) per Regulation (EC) No 1223/2009.
For Food Supplements, we verify labeling, composition, and health claims under Directive 2002/46/EC and Regulation (EC) No 1924/2006.
For Chemical Mixtures and Aromas and Fragrances, we assess Safety Data Sheets (SDS) and related documentation per Regulation (EC) No 1907/2006 (REACH), Annex II.
Our Role: We conduct thorough reviews, provide feedback, and ensure your documentation meets stringent EU requirements, minimizing delays and facilitating CE marking or market notifications.
