Can usability studies replace clinical evaluation?

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.

Which standards apply to Human Factors and Usability?

Key standards include: ISO 62366-1 – Usability engineering for medical devices. ISO 14971 – Risk management for medical devices. IEC 60601-1-6 – Usability requirements for medical electrical equipment. ISO 20916 – Performance studies for IVDs.

Labelling Requirements for Medical and In Vitro Diagnostic Devices for Clinical Use

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: Name of the product or code number Batch or lot number Serial number (wherever applicable) Date of manufacture Use-before date Storage conditions Name and address of the manufacturer The specific purpose for which it has been manufactured “For Clinical Investigation / Evaluation Only – Not for Sale”

What is Form MD-22 and MD-23 (India, Medical Device Rules 2017)

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: The clinical investigation must be registered with the Clinical Trials Registry – India (CTRI) before the enrolment of the first participant. The first participant must be enrolled within one year of the grant of permission; otherwise, fresh permission from the CLA is required.

Can RegHelps handle PMCF for devices already on the market?

Absolutely. We can take over PMCF 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.

Is PMCF mandatory for all CE marked medical devices under MDR?

Yes. Under EU MDR 2017/745, PMCF 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.

Why UKCA Certification Matters for Medical Device Companies

After Brexit, UKCA replaced CE marking in Great Britain. Manufacturers must comply with MHRA rules to legally place devices on the UK market.

Who Needs UKCA Marking?

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)

Is GMP compliance mandatory for medical device manufacturers?

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.

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

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.

FAQs - 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.

Can usability studies replace clinical evaluation?
Which standards apply to Human Factors and Usability?
Labelling Requirements for Medical and In Vitro Diagnostic Devices for Clinical Use
What is Form MD-22 and MD-23 (India, Medical Device Rules 2017)
Can RegHelps handle PMCF for devices already on the market?
Is PMCF mandatory for all CE marked medical devices under MDR?
Why UKCA Certification Matters for Medical Device Companies
Who Needs UKCA Marking?
Is GMP compliance mandatory for medical device manufacturers?
Do your firm provide UDI (Unique Device Identification) Support?

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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