Bring your medical device or IVD to the European market. We support international manufacturers throughout the MDR and IVDR compliance process, from regulatory strategy and classification to technical documentation, QMS, EUDAMED and CE readiness.
Manufacturers placing medical devices or IVDs on the EU market must meet the applicable requirements of Regulation (EU) 2017/745 MDR or Regulation (EU) 2017/746 IVDR.
GSI-CERT supports manufacturers in identifying the applicable regulatory requirements, closing compliance gaps and preparing the documentation and processes required for EU market access.
Regulatory Strategy & ClassificationDetermine the applicable regulatory pathway, device classification and conformity assessment requirements under MDR or IVDR.
Technical DocumentationPrepare, review and update technical documentation according to the applicable MDR or IVDR requirements.
Quality Management SystemEstablish or improve your QMS and prepare your organization for ISO 13485 and applicable MDR/IVDR requirements.
Clinical & Performance DocumentationSupport the preparation and review of applicable clinical evaluation or performance evaluation documentation.
EUDAMED & RegistrationSupport applicable actor, device, UDI and EUDAMED registration requirements for EU market access.
CE ReadinessIdentify remaining compliance gaps and prepare your documentation and organization for the applicable conformity assessment procedure.
Do You Need a Notified Body?Whether a Notified Body is required depends on the device type, classification and applicable conformity assessment procedure.GSI-CERT is not a Notified Body. We support manufacturers in preparing for the applicable conformity assessment process and can coordinate required testing and external certification activities with qualified partners.
From Product to EU Market
1. Regulatory AssessmentWe assess your product, intended purpose, classification and current regulatory status.
2. Gap Analysis & RoadmapWe identify missing regulatory, technical documentation and QMS requirements and define the path to compliance.
3. ImplementationWe support technical documentation, QMS, testing, clinical or performance documentation and applicable registrations.
4. CE ReadinessWe conduct a final compliance review and prepare your organization for the applicable conformity assessment procedure.
5. EU Market AccessWe support EUDAMED, EU representation and additional regulatory requirements where applicable.
Planning to Enter the EU Market?
Tell us about your device, intended purpose and current regulatory status.
Our experts will review your case and respond within 24 hours.