Reduce liability risks under MDR/IVDR
As an importer or distributor, your legal exposure under EU regulations is growing. With stricter obligations and increased liability, proactive compliance is essential. Our support package helps you meet all requirements, clearly, efficiently, and with confidence.
Compliance support for Importers & Distributors under MDR/IVDR
Importers and distributors of medical devices face growing legal responsibilities within the EU market. Under MDR/IVDR—and now the new EU Product Liability Directive (Directive (EU) 2024/2853)—you can be held liable for defective products. Compliance is no longer optional; it’s a legal and financial safeguard.
Certification Experts offers a dedicated support package to help you meet these obligations.
Our solution provides clarity and control with:
- Clear, step-by-step guidelines for your MDR/IVDR duties
- Practical checklists tailored to your role in the supply chain
- Quality management under ISO13485 or custom procedures to implement within your existing quality system
You’ll also have access to ongoing support and direct contact with our specialists—so you’re never alone in the process.
Reduce your legal exposure. Strengthen your compliance.
Let’s safeguard your operations today.
Full-service product compliance
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