Global Regulatory Services (GRS): Your Trusted UK MHRA Importer for Medical Devices and IVDs
Navigating the complexities of UK regulatory requirements can be challenging, especially post-Brexit. Global Regulatory Services (GRS) simplifies this process for you, ensuring your medical devices and In Vitro Diagnostics (IVDs) comply with UK regulations.
Our Services and Duties as your Regulatory Importer:
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Comprehensive Compliance Management:
- UKCA & CE Mark Verification: We ensure your products display the necessary UKCA mark or CE marking, as applicable.
- Documentation Review: We verify your products' Declaration of Conformity and technical documentation.
- Labelling and UDI Checks: We ensure all labelling, Unique Device Identifiers (UDI), and accompanying information (IFU) meet UK standards.
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Independent Representation:
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Economic Operator Registration: We act as your designated economic operator, registered with the MHRA by your UK Responsible Person.
- Increased Independence: Avoid relying on distributors for compliance, maintaining greater control over your products.
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Robust Regulatory Support:
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Storage & Transportation Verification: We confirm that storage and transportation requirements are met.
- Complaint Management: We maintain a register of complaints in line with UK reporting requirements.
- Risk Management: We promptly inform manufacturers if a device poses serious risks or is non-compliant.
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Seamless Integration with Your Operations:
- Collaboration: We work closely with legal manufacturers and UK-responsible persons to ensure the seamless reporting of serious incidents or risks to the MHRA.
- CAPA Support: We assist with Corrective and Preventive Actions (CAPA) to address any compliance issues.
Why GRS?
- Expertise: With years of experience as a regulatory importer and responsible person, GRS has the expertise to navigate complex regulatory landscapes.
- Efficiency: Our streamlined processes ensure quick and seamless compliance, reducing your time to market.
- Reliability: Trust GRS to manage your regulatory responsibilities with professionalism and precision.
Take the Next Step:
With GRS as your trusted partner, ensure your products meet all UK regulatory requirements. Contact us today to learn more about our comprehensive Regulatory Importer services.
Contact Us
Email- grs@globalregulatoryservices.com
Web Form- https://globalregulatoryservices.com/global-regulatory-services-contact-details
