Product liability insurance under your service explain

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?

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?

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?

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?

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).

What is included in a Biological Evaluation Report (BER)?

A Biological Evaluation Report (BER) summarizes the device’s biological risk assessment, including device description, material characterization, exposure categorization, literature review, testing results (if applicable), and a toxicological risk assessment. It concludes whether the device is biologically safe and compliant with ISO 10993.

Is biocompatibility testing always required for biological evaluation?

Not always. If sufficient historical data or literature exists to demonstrate the safety of materials used in the device, some tests may be waived. A gap analysis helps determine whether existing data is adequate or if additional testing (e.g., cytotoxicity, irritation, sensitization) is required to meet regulatory expectations. Its highly recommended to conduct testing of finished salable device before you apply for regulatory clearance.

Do you assist with Notified Body selection?

Yes. We help you identify the most suitable Notified Body based on your device type, risk class, and review timelines and support you throughout the submission and technical documentation review process.

What happens if my device was previously CE marked under MDD?

All MDD-certified devices must transition to MDR compliance by the applicable deadline. Significant changes to the product or intended use may require a full MDR re-certification.

How long does it take to get CE Marking under MDR?

The timeline varies based on device class and documentation readiness. Class I devices may take a few weeks, while Class IIa, IIb, and III devices requiring Notified Body review may take 6–12 months or more.

FAQs - Page 2 of 3 - RegHelps SRC

FAQs

India’s top choice for cost-effective clinical data collection and documentation services.India’s top choice for cost-effective clinical data collection and documentation services.

Product liability insurance under your service explain
How quickly can I appoint your company as my EC REP?
Can you help with Notified Body coordination or CE certification?
Will your EC REP name appear on my product label?
Is appointing an EC REP mandatory for CE marking?
What is included in a Biological Evaluation Report (BER)?
Is biocompatibility testing always required for biological evaluation?
Do you assist with Notified Body selection?
What happens if my device was previously CE marked under MDD?
How long does it take to get CE Marking under MDR?

We combine technical precision with regulatory mastery to guide your medical device from concept to market—ensuring safety, effectiveness, and patient trust every step of the way.

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P : +91 9705835637 / 7019031781

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P : +91 9705835637

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