UK-based biotech SME specialising in women’s health seeks EU regulatory partners for CE-marking and IVDR compliance
A UK based SME specialising in women’s health biotechnology is seeking collaboration with EU-based regulatory organisations or authorised representatives to support CE-marking and ensure compliance with the In Vitro Diagnostic Regulation (IVDR). The company has developed a UKCA-marked digital diagnostic that predicts preeclampsia risk from routine blood tests. It now aims to establish a long-term partnership to facilitate EU certification and market entry.