The Medical Device File: What You Don’t Have to Include in This File

Document

Medical device file according to ISO 13485:2016

Ref.

Technical documentation according to MDR/IVDR

Ref. MDR

FDA: DMR, DHF, DHR

General description of the device

X

4.2.3 a)

X (incl. names)

II.1.1.a)

Variants

X^*)

X

II.1.1. i)

Language versions

X^*)

X

Intended accessories and combinations with other devices

X^*)

X

II.1.1. h)

Intended purpose and intended use

X

4.2.3 a)

X (incl. user, patient group, (contra-) indications)

II.1.1 a), c)

21 CFR part 820.30

Warnings

X

II.1.1. c)

Qualification as medical device

X

II.1.1.e)

Classification

X^*)

X

II.1.1. f)

Mode of action, scientifically demonstrated if necessary, functionality

X

II.1.1. d)

Description of novel features

X

II.1.1 g)

Reference to previous and similar devices

X

II.1.2. a), b)

e.g., for 510(k) approval

Description of the development stages

X

II.3. a)

21 CFR part 820.30 b)

Device specifications, e.g., drawings, calculations, components

X

4.2.3 b)

X (incl. dimensions, performance attributes)

II.1.1. j), l)

21 CFR part 820.181 a)

Software specifications

X^*)

X

II.6.1 b)

21 CFR part 820.181 a)

Relevant GSPR

X

II.4. a)

Materials used, design drawings

X^*)

X (incl. those in contact with the body)

II.1.1 j)

21 CFR part 820.181 a)

Medicinal products used

X^*)

X

II.1.1. k), II.6.2. a)

Tissues of human or animal origin used

X

II.6.2 b)

Toxicity, biological safety, and biocompatibility

X^*)

X

II.6.1 b), II.6.2. d)

(21 CFR part 820.181 c)), 21 CFR part 820.184 d)

Physical, chemical, microbiological, electrical safety

X

II.6.1 b)

(21 CFR part 820.181 c)), 21 CFR part 820.184 d)

Absorption, metabolism, excretion, interaction, tolerance of substances in the body

X

II.6.2 c)

Lifetime, stability, shelf life

X

II.6.1 b)

21 CFR part 820.184 d)

Measurement accuracy (in case of measuring function)

X

II.6.2.ef)[A1] 

21 CFR part 820.184 d)

Interoperability, compatibility

X

II.6.2.g)

(21 CFR part 820.181 c))

Software V&V results

X

II.6.1 b)

21 CFR part 820.30

Specifications for manufacture, e.g., requirements for facilities, infrastructure, production methods

X

4.2.3 c)

(incl. adjuvants, processes, validation)

II.3. b)

21 CFR part 820,181 b)

Quality assurance requirements, e.g., procedures, equipment, acceptance criteria

X^*)

X

II.6.1 (and others)

21 CFR part 820.181 c)

Details of suppliers and contractors with their activities

X

II.3. c)

Packaging specifications, e.g., methods, processes, materials

X

4.2.3 c)

X

21 CFR part 820.181 d)

Specifications (procedures) for measuring and monitoring

X

4.2.3 d)

(21 CFR part 820.181 c))

Requirements for post-market surveillance (PMS), particular the PMS Plan

X

III

Design outputs

X^*)

X

II.6. (and others)

Tests, e.g., laboratory, simulation, animal testing

X

II.6.1 a)

(21 CFR part 820.181a)), 21 CFR part 820.184 d)

Clinical data

X^*)

II.6 c)

Clinical evaluation incl. CER plan

X

II.6.1 c)

PMCF plan

X

II.6.1 d)

Risk management, e.g., risk analysis, risk-minimizing measures, list of residual risks, risk-benefit evaluation

X^*)

X

II.5. a), b)

Storage requirements

X

4.2.3 c)

Specifications for transport

X^*)

4.2.3 c)

Specifications for distribution

X

4.2.3 c)

Requirements for installation

X

4.2.3 e)

21 CFR part 820.181e)

Requirements for maintenance and servicing

X

4.2.3 f)

21 CFR part 820.181d)

Instructions for use

X

4.2.3 c)

X

II.2.

Other labeling

X

4.2.3 c)

X (packaging)

II.2.

UDI

X^*)

X (Basic UDI)

II 1.1. b)

Changes to the device during its lifetime and related V&V

X^*)

List of standards (or “other methods”) used to demonstrate conformity

X^*)

X

II.4. b), c)

(Documents to) demonstrate conformity with GSPR

X^*)

X

II.4. d)