Medical Device & IVD Regulatory FAQs
Answers to common questions on medical device and IVD regulation from the Reghelps QARA Team. Each topic below links to the service page with the full explanation, process and requirements.
Find answers by topic
EU MDR (medical devices)
- MDR CE Marking
- MDR Classification
- MDR Technical Documentation
- European Authorised Representative
- Post-Market Clinical Follow-Up (PMCF)
- Clinical Investigation (ISO 14155)
- Human Factors and Usability
EU IVDR (in vitro diagnostics)
- IVDR CE Marking
- IVDR Classification
- IVDR Technical Documentation
- IVDR Performance Evaluation (PEP, PER, PMPF)
- IVD Performance Studies
United Kingdom
US FDA
- FDA 510(k) Premarket Notification
- FDA Device Classification
- FDA Registration and Listing
- 21 CFR 820 / QMSR
- FDA Inspection Readiness
Quality systems and safety
- ISO 13485 Certification
- MDSAP Certification
- GMP Consultants
- ISO 14971 Risk Management
- Biological Evaluation
Frequently asked questions
- All
- 21 CFR 820
- Biological Evalaution
- Clinical Investigation
- EAR
- FDA 510K
- FDA GMP
- FDA Reg
- GMP-ISO
- Human Factors
- IVD PER
- IVDR
- MDR CE Marking
- PMCF
- UK MHRA
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.
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
- Improved Document Control
- Effective Audit Management
- Better Employee Training Programs
- Better Risk Management
- Efficient Tracking and Reporting
- Improved Supplier Quality
- Robust CAPA Processes
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.
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.
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.
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.
IVDR requires manufacturers to demonstrate scientific validity, analytical performance, and clinical performance, as outlined in Annex I (GSPR 9-13) and detailed further in Annex XIII.
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
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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:
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UDI-DI and UDI-PI structure guidance
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Compliance with GS1, HIBCC, or ICCBBA issuing agencies
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UDI label and packaging review
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Preparation for EUDAMED UDI/Device registration module
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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.
Yes, GMP compliance is mandatory for medical device manufacturers who market products in the United States. The FDA enforces GMP through the Quality System Regulation (21 CFR Part 820), which outlines the minimum requirements for design, production, labeling, packaging, and storage of medical devices to ensure safety and effectiveness.
All medical devices sold in England, Scotland, and Wales must be UKCA certified unless CE marked under special transition rules (valid until mid-2028 for some devices)
After Brexit, UKCA replaced CE marking in Great Britain. Manufacturers must comply with MHRA rules to legally place devices on the UK market.
Yes. Under EU MDR 2017/745, Post Market Clinical Follow Up is a mandatory and ongoing activity for all CE-marked medical devices, regardless of risk class. The extent of PMCF activities may vary depending on the device’s risk profile, clinical history, and available data.
Absolutely. We can take over Post Market Clinical Follow Up activities for devices already CE-marked and on the EU market, ensuring that your data collection, evaluation, and reporting fully meet MDR requirements — even if your existing documentation needs corrective action before the next Notified Body audit.
Form MD-22: This is the application form submitted to the Central Licensing Authority (CLA) (i.e., DCGI under CDSCO) to seek permission for conducting a clinical investigation of a new medical device or an investigational medical device without a predicate device in India.
Form MD-23: If the CLA is satisfied with the application, it grants permission to conduct the clinical investigation through Form MD-23. This permission allows the sponsor to begin the study in accordance with an approved clinical investigation plan reviewed by a registered Ethics Committee.
Additional requirements:
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The clinical investigation must be registered with the Clinical Trials Registry – India (CTRI) before the enrolment of the first participant.
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The first participant must be enrolled within one year of the grant of permission; otherwise, fresh permission from the CLA is required.
Any medical device or new in vitro diagnostic medical device that is imported or manufactured for the purpose of clinical investigation, clinical performance evaluation, testing, evaluation, demonstration, or training must be kept in containers with labels clearly indicating:
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Name of the product or code number
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Batch or lot number
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Serial number (wherever applicable)
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Date of manufacture
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Use-before date
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Storage conditions
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Name and address of the manufacturer
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The specific purpose for which it has been manufactured
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“For Clinical Investigation / Evaluation Only – Not for Sale”
Key standards include:
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ISO 62366-1 – Usability engineering for medical devices.
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ISO 14971 – Risk management for medical devices.
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IEC 60601-1-6 – Usability requirements for medical electrical equipment.
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ISO 20916 – Performance studies for IVDs.
No. Human Factors studies complement but do not replace clinical evaluation. They specifically assess device-user interaction, whereas clinical evaluation assesses clinical performance, safety, and benefits.
Yes. Under Regulation (EU) 2017/746, every IVD device, regardless of risk class, must have a Performance Evaluation Report supported by adequate analytical and clinical performance data before CE marking.
The FDA requires analytical and clinical validation data under 21 CFR Part 809 and relevant guidance documents, generally submitted through a 510(k), De Novo, or PMA pathway, whereas IVDR requires a Performance Evaluation Report following Annex XIII for CE marking.
Common parameters include trueness, precision (repeatability and reproducibility), analytical sensitivity, analytical specificity, limit of detection and quantitation, linearity, cut-off values, carry-over, and stability.
Clinical performance is typically demonstrated through diagnostic sensitivity, diagnostic specificity, positive and negative predictive values, likelihood ratios, and expected values in normal and affected populations.
A prospective clinical performance study is generally required for higher-risk IVDs or when existing literature and equivalent device data are insufficient to demonstrate the intended clinical performance claims.
No. The extent of analytical and clinical performance evidence required depends on the device’s risk classification (such as Class A, B, C, or D under IVDR) and its intended purpose.
ISO 20916 provides the internationally recognized framework for good clinical practice in the design, conduct, and reporting of clinical performance studies using specimens from human subjects.
Insufficient or poorly designed performance evaluation data is a common reason for Notified Body or FDA rejection, so studies should be planned early, aligned with regulatory guidance, and, where needed, supported by a CRO with relevant experience.
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Our QARA team answers questions on EU MDR, IVDR, UKCA, US FDA and quality systems. Send us your question and we will reply by email.
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