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

ISO 13485 requires a medical device file for each medical device type or medical device group. A lot of many manufacturers think that the medical device file is the same as the technical documentation required by the MDR or IVDR. But that isn’t entirely true.

Is one of the three files required by the FDA (DMR, DHF, DHR) the same as the medical device file? It's time for a comparison to end unnecessary discussions within your team and with auditors. With a free download.

1. The medical device file: what ISO 13485 aims for and demands

ISO 13485 has required a medical device file since the 2016 edition. The aim of this is to ensure that manufacturers create (and maintain) all the documents required to demonstrate compliance with the regulatory requirements.

The standard talks about “compliance with applicable regulatory requirements.” By this, it means the requirements of, for example, the MDR and IVDR, for medical devices placed on the market in Europe. For devices regulated by the FDA, this would refer, for example, to the requirements of 21 CFR part 820.

However, ISO 13485:2016 is not limited to references to other regulations. In fact, it defines which documents the medical device file must (at least) contain, regardless of the jurisdiction.

2. Medical device file versus technical documentation versus “FDA files”

a) MDR, IVDR: Technical documentation

Annex II of the Medical Device Regulation (MDR) and Annex II of the EU Regulation on In Vitro Diagnostic Medical Devices (IVDR) both set out the requirements for the technical documentation. The post-market surveillance (PMS) plans defined in Annex III in both regulations are also considered part of the technical documentation.

Further information

Read more on the subject of the technical documentation here.

b) FDA: DHF DMR, DHR,

The FDA distinguishes between three different files:

  1. Design history file (DHF) according to 21 CFR part 820.30
  2. Device master record (DMR) according to 21 CFR part 820.181
  3. Device history record (DHR) according to 21 CFR part 820.184

c) Comparison of the files

The following table compares these requirements.

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)

 

Table 1: X*) means that it is not ISO 13485 itself but rather the “Practical Guide” that recommends the document .

NB!

Careful! Just because a cell is not marked with an X, it should not be concluded that the regulation does not require the document. It just doesn’t mention it explicitly.

Author:

Prof. Dr. Christian Johner

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