By Strategic Area
Regulatory Services – We4 Regulatory
For medical device manufacturers navigating the regulatory pathway to CE marking for their products in Europe, including clinical investigations, clinical evaluation, and post-market surveillance.
We4 Regulatory is the regulatory consulting division of We4 Clinical Research S.r.l., dedicated to providing regulatory support for medical devices. It is not a separate legal entity, and all regulatory services are invoiced by We4 Clinical Research.
Technical documentation and clinical evaluation
We contribute to the Clinical Evaluation Report (CER), support the completion of the checklist of General Safety and Performance Requirements (GSPR) and review the Investigator’s Brochure and instructions for use, for consistency between clinical data and regulatory documentation.
Clinical investigations on devices (ISO 14155)
We draft the Clinical Investigation Plan (CIP) in accordance with ISO 14155 and the MDR and take care of its registration in EUDAMED when required, working with the clinical team that will conduct the study.
Notified Body relations
We support you in your interactions with the Notified Body: preparing answers to questions and following up on the documentation requested.
Vigilance and post-market follow-up
We manage the vigilance reports required by the MDR (incidents and field safety corrective actions, FSCA) and draft the PMCF plan and report: details are on the Post-market services page.
FAQ — Regulatory services
MDR classification has to be assessed case by case on your specific product: we do not anticipate a class without having analyzed the documentation. It is the first step of the work we do together.