At QNET, we provide comprehensive legal representation services tailored to the needs of medical device manufacturers entering and operating in the European Union (EU), the United Kingdom (UK), Switzerland, and the United States. Our services ensure compliance with regulatory frameworks, including the requirements for clinical investigations outlined in the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746).
Why Choose QNET as Your Legal Representative?
- EU Authorized Representative (EU MDR)
As your EU Authorized Representative, we act as the liaison between your company and EU authorities. We assist in ensuring compliance with all MDR requirements, including support for clinical investigations (MDR Articles 62-80). This includes reviewing and advising on the documentation necessary for clinical investigations, such as the clinical investigation plan, ethics committee approvals, and compliance with General Safety and Performance Requirements (GSPR). - UK Responsible Person (UKRP)
For manufacturers selling in the UK, we fulfill the role of UKRP, meeting the requirements of UK medical device regulations. This includes guidance on clinical investigation documentation needed for product approvals in the UK market. - Swiss Representative (CH-REP)
We navigate the Swiss regulatory framework, which closely aligns with MDR requirements. As your CH-REP, we ensure compliance with clinical investigation obligations and post-market surveillance activities. - US Agent Services
For non-US manufacturers seeking FDA compliance, we serve as your US Agent, facilitating communication with the FDA, including clinical trial requirements and premarket submissions.
Support for Clinical Investigations
Clinical investigations are crucial in demonstrating medical devices' safety, performance, and clinical benefits. As part of our legal representative services, we provide:
- Compliance Guidance: Ensuring clinical investigations meet MDR and IVDR requirements, including mandatory reporting, ethics committee reviews, and competent authority notifications.
- Documentation Review: Assistance in preparing and reviewing clinical investigation plans, investigator brochures, and patient information.
- Post-Investigation Support: Support in submitting clinical investigation reports and integrating findings into technical documentation.
- Regulatory Alignment: Ensuring alignment with MDR and IVDR General Safety and Performance Requirements (GSPR) and related clinical evaluation processes.
Our Distinctive Advantages
- In-House PRRC Expertise
Our team includes registered Persons Responsible for Regulatory Compliance (PRRC), ensuring that your clinical investigation documentation and post-market activities align with MDR and or IVDR requirements. - Global Reach, Local Expertise
With offices in the EU, UK, Switzerland, and the US, we offer localized expertise while maintaining a global perspective on regulatory compliance. - Tailored Solutions
We design customized strategies to fit your company's specific needs, ensuring smooth regulatory pathways and effective market entry.
What We Offer
- Regulatory representation and compliance monitoring.
- Clinical investigation guidance and documentation support.
- Technical documentation review and submission.
- Registration with relevant authorities.
- Post-market surveillance and vigilance reporting.
- Liaison services for audits and inspections.
- Expert advice on evolving regulatory landscapes.
Partner With QNET for Seamless Market Access
With years of experience and a proven track record in regulatory compliance, QNET is your trusted partner for navigating complex legal and regulatory requirements. Let us help you focus on innovation while we manage the regulatory landscape, including clinical investigation requirements for your products.