What are the key documents required for MDR CE Marking?

Some key documents include the Technical Documentation (Annex II & III), Clinical Evaluation Report (CER), Risk Management File, PMS/PMCF Plans, and labeling/instructions for use (IFU) compliant with GSPR

Who needs to comply with EU MDR 2017/745?

All medical device manufacturers intending to sell devices in the EU, including Class I, IIa, IIb, and III must comply with the MDR.

What is the usual timeline for IVD Class B,C and D device CE Certification

Based on the number of models and varients the timeline may change. usually the timeline for class B is approx 8-10 montsh and Class D is 14 months.

Responsibilities of US Agent?

Foreign manufactures and exporters interested in selling medical devices in the USA can approach us. Our extensive knowledge of FDA regulations will aid in a smooth and efficient registration process. We the US Agents awake and answer any time when authorities ask for information. In addition to our US office, we have offices in Germany, India, Malaysia, UK and Vietnam. We are not just like others, we have a big team of device experts, consultants and project managers who can handle any type of service to your organization. The US Agent Service is vital for FDA medical device registration of foreign medical and in-vitro diagnostic devices manufacturers and initial exporters. Check the responsibilities of the US agents.

Transfer of US Agent Possible? Explain the process

Yes, manufacturers / exporter any time they can transfer the US Agent. We are happy to act as US Agent for any non-US manufacturers. Please bring us the FDA FURLS account login details to update the Agent Information.

The drug Master Files are divided into 4 Types Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel Type II: Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product Type III: Packaging Material Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation Type V: FDA Accepted Reference Information We provide US Agent service and E copy submission service. We also help with DMF preparation.

Benefits of 21 CFR 820 Implementation

Improved Document Control Effective Audit Management Better Employee Training Programs Better Risk Management Efficient Tracking and Reporting Improved Supplier Quality Robust CAPA Processes

Do you provide Label Review Service?

Yes we provide Food, Cosmetic, Drug and cosmetic label review service. https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling https://www.fda.gov/drugs/development-resources/labeling-information-drug-products

What Documents and how to submit 510k file?

The 510(k) file includes documents used to establish the safety and efficiency of the proposed medical device through substantial equivalence. The documents included in the 510(k) file are: Form FDA 3601: Medical Device User Fee Cover Sheet (MDUFC sheet) FDA Form 3514- CDRH Premarket Review Submission Cover Sheet: This document includes basic administrative and device information. 510(k) Cover Letter: This document provides a brief idea about the purpose of the submission, device, manufacturer and the U.S agent (if any). FDA Form 3881: Indications for Use Statement 510(k) Summary or 510(k) Statement: This includes a summary of the device undergoing the 510(k) clearance. Truthful & Accuracy Statement: This is to certify that the 510(k) submission contents are truthful and accurate and no information omitted. Class III Summary and Certification: If the proposed device is a Class III exempt from PMA, otherwise, this can be marked as not applicable. Financial Certification or Disclosure Statement: This is applicable only if clinical studies were conducted Declarations of Conformity and Summary Reports: Lists the voluntary consensus standards used and includes DOC to such standards. Device Description: This document includes the description of the device design requirements and performance specifications. Executive Summary: a brief description of the device & comparison table with the predicate device identified. Substantial Equivalence Discussion: Detailed comparison between the proposed device and the predicate device chosen. Proposed Labeling: Is discussed in detail to comply with 21 CFR 807.87(e) for general medical devices and 21 CFR 809.10 for IVD’s Sterilization and Shelf Life: This document provides details regarding the sterilization and shelf life claim being made. Biocompatibility: This document is applicable if the proposed device comes into direct or indirect contact with the human body tissue. Software: This includes the documentation for any software used in the proposed device Electromagnetic Compatibility and Electrical Safety- If the proposed device is powered electrically, in which case the EMC must be evaluated. Performance Testing – Bench: This document included details of the bench tests performed to evaluate the efficiency of the proposed device. Performance Testing – Animal: This document included details of the animal testing performed to evaluate the efficiency of the proposed device. Performance Testing – Clinical: This document included details of the clinical studies performed to evaluate the efficiency of the proposed device. The completed FDA 510(k) file is submitted in electronic format as an e-copy to the FDA. The submission package is sent to the CDRH through registered mail or commercial delivery service.

FAQs - Page 3 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.

What are the key documents required for MDR CE Marking?
Who needs to comply with EU MDR 2017/745?
What is the usual timeline for IVD Class B,C and D device CE Certification
Responsibilities of US Agent?
Transfer of US Agent Possible? Explain the process
US FDA DMF
Benefits of 21 CFR 820 Implementation
Do you provide Label Review Service?
What Documents and how to submit 510k file?

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