Entering the European market with medical devices or in-vitro diagnostic devices involves adhering to strict regulatory requirements to ensure compliance with the Medical Device Regulation (MDR) or In-Vitro Diagnostic Device Regulation (IVDR). In this blog we will share key steps when entering into the European market and how OneGlobal Trinity M Consulting can support each step of the process.
1. Obtain Product Approval
Before entering the EU market, manufacturers must complete the European CE Marking process. For low-risk devices, self-certification by the manufacturer is sufficient. However, for higher-risk devices, CE Marking certification through a Notified Body is mandatory.
Key Steps:
Identify the applicable regulation (MDR or IVDR).
Classify the device's risk level.
Conduct a conformity assessment to demonstrate compliance with safety and performance standards.
Obtain certification through a Notified Body (if required).
How Trinity M Consulting Helps: Trinity M Consulting can guide you through the conformity assessment process, helping to ensure all documentation, testing, and submissions meet the stringent MDR/IVDR requirements. We can also facilitate communication with Notified Bodies, ensuring that your application is clear and complete.
2. Appoint an In-Country Representative (European Authorized Representative)
If you are not based in the European Union, Great Britain, or Switzerland, you must appoint a European Authorized Representative (EC-REP) to represent your company to the regulatory authorities.
Key Steps:
Identify and appoint an EC-REP within the EU.
Ensure that the EC-REP’s information appears on your device labels and instructions for use.
How Trinity M Consulting Helps: Trinity M Consulting offers direct support in appointing a qualified European Authorized Representative. We ensure that your representative is capable of handling the regulatory requirements and acting as your liaison with the European authorities.
3. Register Your Device with the Regulatory Authority
Device registration within the European Database on Medical Devices (EUDAMED) is a critical step for all manufacturers. The registration process involves two parts: company registration (completed through the Actor Registration module) and device registration (through the UDI/Device Registration module).
Key Steps:
Register the company through EUDAMED and obtain a Single Registration Number (SRN).
Register your medical device, providing the required information in the UDI/Device Registration module.
How Trinity M Consulting Helps: Trinity M Consulting assists with EUDAMED registration, ensuring compliance with the current requirements. We monitor regulatory updates, providing proactive solutions for maintaining compliance during the transition to mandatory EUDAMED registration.
4. Identify and Register Importer
Under MDR/IVDR, the importer is responsible for ensuring that medical devices from non-EU countries comply with EU regulations. The importer must register in EUDAMED and be identified on the device's label or accompanying documents.
Key Steps:
Identify an EU-based importer.
Ensure the importer is registered in EUDAMED and linked to the manufacturer.
How Trinity M Consulting Helps: Trinity M Consulting can assist in identifying and registering an importer who understands the legal responsibilities under MDR/IVDR. We work closely with importers to ensure smooth communication and compliance throughout the supply chain.
5. Maintain Compliance with CE Marking and EUDAMED
Once your product is on the market, ongoing compliance is crucial to maintaining your CE Marking certification. This includes updating the EUDAMED database whenever there are changes in device models, CE certificates, or your company's details.
Key Steps:
Ensure compliance with MDR/IVDR throughout the product lifecycle.
Update EUDAMED registration when necessary.
Transition to full EUDAMED registration when the system becomes mandatory.
How Trinity M Consulting Helps: We help you develop and implement robust compliance programs to maintain your CE Marking status. Our team provides ongoing support with EUDAMED updates, CE certificate renewals, and addressing any regulatory changes.
Conclusion
Navigating the European regulatory landscape can be complex, but with the right guidance, it can be a streamlined process. OneGlobal Trinity M Consulting brings years of experience and expertise in regulatory affairs, ensuring that your medical device or IVD is fully compliant and ready for the EU market. We offer end-to-end support from product approval to maintaining post-market compliance, helping you minimize delays and maximize success.
Contact OneGlobal Trinity M Consulting today to discuss how we can support your entry into the European market.
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