Regulatory and compliance

Regulatory & Compliance Services for MedTech and IVD

Bringing a medical device or IVD to Europe demands more than science. Companies must meet MDR/IVDR rules, create compliant documentation, and maintain obligations after CE marking.

Through partnerships with experienced regulatory specialists, Truly Labs provides integrated regulatory and scientific support for MedTech and IVD companies operating in the EU.

We support organisations across the full device regulatory lifecycle, including:

• Regulatory strategy and CE marking roadmap
• Technical documentation preparation and EU Declaration of Conformity
• Clinical evaluation and performance evaluation planning
• Post-market surveillance (PMS) and post-market performance follow-up (PMPF)
• Vigilance and incident reporting obligations
• Person Responsible for Regulatory Compliance (PRRC) available as an outsourced function under Article 15 of MDR and IVDR
• AI and digital health regulatory considerations

A common challenge for MedTech and IVD innovators is translating strong scientific data into regulatory-ready documentation. Our integrated approach bridges that gap by aligning laboratory evidence, performance studies, and regulatory strategy from the beginning.

This is particularly valuable for biomarker-driven diagnostics, molecular diagnostics, and precision medicine applications, where the scientific rationale must be clearly articulated in both the performance evaluation report and the clinical evidence summary.

Our services are designed for small and mid-size MedTech, biotech, and diagnostic companies that need scientific rigour and regulatory expertise without building large in-house teams. We support companies from early feasibility and assay development through CE marking and post-market compliance.