Non-EU manufacturers placing medical devices or IVDs on the European market must appoint an Authorized Representative in accordance with EU MDR 2017/745 and IVDR 2017/746.
Qualitech International acts as your official European Authorized Representative, ensuring regulatory compliance, communication with Competent Authorities, and continuous post-market support. We protect your regulatory interests while enabling smooth and secure access to the EU market.
Trusted Representation with Regulatory Accountability
We provide structured, transparent, and fully compliant Authorized Representative services designed to safeguard your European market presence.
- Official EU-based Authorized Representative services.
- Full compliance with MDR Article 11 obligations.
- Secure document verification and regulatory oversight.
- Structured communication with EU authorities.
- Support for vigilance and post-market requirements.
- Reliable partnership ensuring long-term compliance.
What We Offer ?
Acting on your behalf within the European Union in full accordance with MDR and IVDR requirements.
Review and confirmation that Technical Documentation and Declaration of Conformity meet regulatory obligations.
Assistance with incident reporting, corrective actions, and regulatory follow-up activities.
Direct liaison with Competent Authorities and regulatory bodies when required.
Guidance and support for SRN registration and EUDAMED obligations.
Ensuring your documentation remains compliant with evolving standards.
Why Choose Qualitech International ?
Strong Compliance Oversight
We verify documentation carefully to minimize regulatory risks and prevent non-conformities.
Regulatory Expertise & Accountability
We understand the legal responsibilities of an EU Authorized Representative and act with full compliance and diligence.
Proactive Communication
We ensure structured, timely interaction with Competent Authorities whenever required.
Frequently Asked Questions
Have questions about regulatory compliance, market access, or our services?
Here are answers to the most common inquiries from Medical Device and IVD manufacturers.
Do I need an EU Authorized Representative if I sell through a European distributor?
Yes. Under the MDR/IVDR, if you are a non-EU manufacturer, you are legally required to appoint a single, designated EU Authorized Representative, regardless of how many distributors you use.
Can Qualitech act as our UK Responsible Person (UKRP) as well?
Absolutely. In addition to EU-Rep services, we offer dedicated UKRP services to ensure your continued compliance and market access in the United Kingdom post-Brexit.
What happens if there is an adverse event involving our device in Europe?
As your EU-Rep, we are the primary point of contact for Competent Authorities. We will work closely with your team to ensure the incident is reported within the legally mandated timeframes and coordinate any necessary corrective actions.
