EAR – RegHelps SRC

Do your firm provide UDI (Unique Device Identification) Support?

adminreg — Tue, 05 Aug 2025 11:14:05 +0000

Yes, we provide full support for UDI implementation and registration in compliance with EU MDR 2017/745 and IVDR 2017/746 requirements. Our team assists manufacturers in assigning and structuring UDI-DI and UDI-PI codes based on the device classification and intended use. We also help in ensuring proper placement of UDI on labeling, packaging, and Instructions for Use (IFU), as well as preparing for UDI module submission once it becomes fully functional within EUDAMED.

Our services cover:

UDI-DI and UDI-PI structure guidance
Compliance with GS1, HIBCC, or ICCBBA issuing agencies
UDI label and packaging review
Preparation for EUDAMED UDI/Device registration module
UDI-related documentation for your Technical File and CE submission

By integrating UDI properly, we help ensure device traceability, reduce market delays, and support full regulatory compliance across the EU.

Product liability insurance under your service explain

adminreg — Tue, 05 Aug 2025 10:04:52 +0000

As part of our commitment to regulatory compliance and risk management, we recommend that all non EU manufacturers have valid Product Liability Insurance when appointing us as their European Authorized Representative (EC REP). While it is not a legal requirement under MDR/IVDR for the EC REP to request proof of insurance, many Competent Authorities and Notified Bodies may inquire about the manufacturer’s liability coverage during inspections or audits. Having proper insurance also demonstrates due diligence and protects your business in the event of product-related claims in the European market. We do not provide insurance ourselves, but we can guide you on what to include based on your device risk class and market exposure.

How quickly can I appoint your company as my EC REP?

adminreg — Tue, 05 Aug 2025 09:25:11 +0000

We offer fast onboarding, typically within 1–2 working days upon receipt of the necessary documentation and agreement. We also guide you through label updates and document handovers to ensure a smooth transition.

Can you help with Notified Body coordination or CE certification?

adminreg — Tue, 05 Aug 2025 09:23:44 +0000

Absolutely. In addition to EC REP services, we offer end-to-end regulatory consulting, including Notified Body selection, technical file preparation, and gap analysis to support your CE Marking journey efficiently.

Will your EC REP name appear on my product label?

adminreg — Tue, 05 Aug 2025 09:21:59 +0000

Yes. According to MDR and IVDR requirements, the EC REP’s name and address must be clearly visible on the product labeling, outer packaging, or accompanying documents, allowing EU authorities to easily identify the representative.

Is appointing an EC REP mandatory for CE marking?

adminreg — Tue, 05 Aug 2025 09:20:10 +0000

Yes. If your company is based outside the EEA and wishes to market medical devices or IVDs in Europe, it is legally required to appoint an EC REP. This representative’s name and address must appear on the product labeling, outer packaging, or Instructions for Use (IFU).