European Union · MDR Class I
SUNGO supports ordinary Class I medical device CE compliance, from classification and technical documentation to EU authorised representation and post-market activities.
Why SUNGO
SUNGO Europe B.V. and Sungo Cert GmbH provide EU authorised representative services. Europe-based staff and our regulatory team coordinate technical documentation, registration information and authority enquiries.
A Person Responsible for Regulatory Compliance (PRRC) and deputy PRRC based in Europe contribute registration, quality-management and legal experience to authority case handling and manufacturer communication.
We review technical documentation, declarations of conformity and relevant certificates, assist with SRN registration and retain documents. Missing or inconsistent information is followed up with the manufacturer.
Our team receives market feedback, maintains authority case records and assists manufacturers with response materials and corrective actions. Representation continues beyond signing the mandate.
Service scope
Choose individual services or a coordinated project based on your device and existing documentation.
Review intended purpose, applicable rules and the model range.
Prepare device descriptions, design and manufacturing information and evidence addressing the General Safety and Performance Requirements.
Support risk analysis, risk controls and clinical evaluation documentation.
Review existing reports and identify additional performance or safety evidence needed.
Review labeling and instructions for use and assist with the EU declaration of conformity.
EU authorised representative services, SRN, Basic UDI-DI and applicable database registration assistance.
Support quality management, post-market surveillance, complaints, vigilance and change management.
Working with SUNGO
The sequence is tailored to your project. Some activities may run in parallel.
Review intended purpose and characteristics to confirm the proposed classification.
Assess test reports, quality-system records and technical documentation.
Coordinate required testing, risk management, clinical evaluation and GSPR documentation.
Coordinate the EU representative, UDI information and applicable registrations.
Assist the manufacturer with its declaration of conformity and CE marking preparation.
Support post-market surveillance, vigilance and registration updates.
Product experience
This page focuses on ordinary Class I devices, excluding sterile devices, devices with a measuring function and reusable surgical instruments. Examples require individual classification review: intended purpose, functions and supply condition can change the applicable classification.
Manual examination couches, patient transport trolleys and non-powered transfer aids.
Manual wheelchairs, walking aids, crutches and shower chairs.
Impression trays, wedges, rubber dam frames and bite blocks.
Spectacle lenses, trial lenses and trial frames.
European entities
SUNGO Europe B.V. in the Netherlands and Sungo Cert GmbH in Germany provide EU authorised representative services. Regulatory, laboratory and Europe-based staff coordinate documentation and ongoing representation matters according to the agreed project scope.
Free initial consultation
Email the product name and instructions for use. Our team will respond within one business day to discuss the next steps.