Requirement Analysis for Medical Device File (ISO 13485) Device Master File (India Medical Device Rules 2017) and Technical File (EU MDR 2017745)

1

Device Description and Specification

Product or trade name and general description of the device

Yes

Yes

Yes

Basic UDI DI or clear identification

Yes

Intended use including Intended patient population and medical conditions

Yes

Yes

Yes

Principles of operation and mode of action

Yes

Yes

Rationale for the qualification of the product as a device

Yes

Yes

Explanation of novel features

Yes

Yes

Description of accessories and other products used in combination with the device

Yes

Yes

Yes

Description or complete list of device configurations/variants available on the market

Yes

Yes

Yes

General description of key functional elements

Yes

Yes

Yes

Description of raw materials in key functional elements

Yes

Technical specifications

Yes

Yes

Yes

2

Reference to Previous and Similar Generations of the Device

Overview of previous generations of the device

Yes

Yes

Overview of identified similar devices on the market

Yes

Yes

3

Information to be Supplied by the Manufacturer

Complete set of labels on the device and packaging

Yes

Yes

Yes

Instructions for use

Yes

Yes

Yes

4

Design and Manufacturing Information

Complete information and specifications of manufacturing processes

Yes

Yes

Yes

Identification of all sites (suppliers and subcontractors) involved in design and manufacturing

Yes

5

General Safety Performance Requirements or Essential Requirements

List of general safety and performance requirements applicable to the device

Yes

Yes

Identification of controlled documents providing evidence of conformity

Yes

Yes

6

Risk Management

Documentation of risk analysis

Yes

Yes

Solutions adopted and results of risk management

Yes

Yes

7

Product Verification and Validation

Results and analyses of all verifications and validation tests/studies

Yes

Yes

8

Pre clinical and Clinical Data

Results of engineering, laboratory, simulated use, and animal tests

Yes

Yes

Detailed information on test design, protocols, methods of data analysis

Yes

Yes

Biocompatibility of the device

Yes

Yes

Physical, chemical, and microbiological characterisation

Yes

Yes

Electrical safety and electromagnetic compatibility

Yes

Software verification and validation

Yes

Yes

Stability (including shelf life)

Yes

Yes

Performance and safety

Yes

Yes

Clinical evaluation & Clinical evidence updates

Yes

Yes

PMCF plan and evaluation report or justification for non applicability

Yes

9

Additional Information

Statement if the device incorporates substances that may be considered medicinal products

Required in Specific Cases

Required in Specific Cases

Required in Specific Cases

Identification of materials from human/animal origin

Yes

Yes

Detailed studies on absorption, distribution, metabolism, and excretion

Yes

Local tolerance and toxicity studies

Yes

Description of environmental conditions for sterile devices

Yes

Yes

Methods ensuring accuracy for devices with measuring functions

Yes

Yes

Description of device combinations/configurations with other devices

Yes

Yes

10

Regulatory Status

Regulatory status of similar devices in India (approved/not approved)

Yes

List of regulatory approvals or marketing clearances obtained

Yes

11

Certificates

Design Examination Certificate

Yes

Declaration of Conformity

Yes

Yes

Mark of Conformity Certificate

Yes

Design Certificate (if applicable)

Yes

12

Pricing Information

Domestic price of the device in the currency of the country of origin

Yes

13

Radiation Source Information

Details on radiation source and shielding materials

Yes

14

Post Marketing Surveillance

Procedures and data collected from Post Marketing Surveillance or Vigilance Reporting

Yes

Yes

15

Batch record for 3 consecutive batches

Batch Release Certificates and Certificate of Analysis of finished product for a minimum 3 consecutive batches should be submitted

Yes

16

Installation and servicing

Procedures for installation and Servicing should be created

Yes