European Union - EU MDR Submissions

Service Description

HeurNova provides full-spectrum consulting support for medical device manufacturers navigating the EU Medical Device Regulation (MDR) 2017/745. We assist with the preparation, organization, and submission of technical documentation (Annex II & III) to notified bodies, ensuring traceability and conformity across design, risk, and clinical evidence. Services include: • Gap analysis of existing MDD technical files against MDR 2017/745 requirements • Device classification verification and regulatory strategy • Construction and formatting of the Technical Documentation File (TDF) and Summary of Safety and Clinical Performance (SSCP) • Alignment of QMS with ISO 13485:2016 and MDR Annex IX audit expectations • Clinical evaluation report (CER) and post-market surveillance (PMS/PMCF) documentation support • Submission coordination with notified bodies and response to deficiency letters Deliverables are submission-ready, harmonized with current MDCG guidance, and built to withstand notified-body scrutiny.