>

CONTROLLED DOCUMENT 12.1.19-GREF-2 Status: Effective Effective Date: 06/May/2022

BAUSCH + LOMB 12.1.19-GREF-2

Global Reference Document Revision: 1
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 1 of 8
Effects) for Pharma Medical Devices

Purpose
This document provides a list of Pharma complaint reasons and IMDRF Codes for Annexes A, E and F to assist the user in selecting
the appropriate codes for Pharma Medical Device complaints. Refer to Documents (imdrf.org) for additional IMDRF codes.

Annex A Annex E Annex F

Complaint Reason Annex E IMDRF Code Description
IMDRF Code and Term IMDRF Code and Term IMDRF Code and Term
Accessory Missing No patient involvement or, no observable clinical
A020602 Component E2403 No Clinical Signs, F26 No Health
(i.e. leaflet, eye symptoms or a change in symptoms is identified in the
Missing Symptoms or Conditions Consequences or Impact
cup, etc) patient.
No patient involvement or, no observable clinical
A0201 Product Quality E2403 No Clinical Signs, F26 No Health
Adhesion symptoms or a change in symptoms is identified in the
Problem Symptoms or Conditions Consequences or Impact
patient.
A24 Adverse Event F24 Insufficient Health effect appears to have occurred but there is not yet
E2401 Insufficient
Adverse Event Without Identified Device Information Insufficient enough information available to classify the clinical signs,
Information
or Use Problem Information symptoms, and conditions.
E0402
A24 Adverse Event A local or general reaction of an organism following
Hypersensitivity/Allergic F11 Minor Injury/ Illness/
Allergic Reaction Without Identified Device contact with a specific allergen to which it has been
reaction Impairment
or Use Problem previously exposed and to which it has become sensitized.
No patient involvement or, no observable clinical
Appearance A0201 Product Quality E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
(Product) Problem Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
A0406 Material E2403 No Clinical Signs, F26 No Health
Bent Needle symptoms or a change in symptoms is identified in the
Deformation Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
Black Mold A1801 Contamination symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
Bottle Deformed / A0406 Material E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
Melted Deformation Symptoms or Conditions Consequences or Impact
patient.
A24 Adverse Event
F11 Minor Injury/ Illness/ A mild injury, illness or impairment which can be treated
Breakouts Without Identified Device E1717 Skin disorders
Impairment with minimal or no intervention.
or Use Problem

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CONTROLLED DOCUMENT 12.1.19-GREF-2 Status: Effective Effective Date: 06/May/2022

BAUSCH + LOMB 12.1.19-GREF-2

Global Reference Document Revision: 1
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 2 of 8
Effects) for Pharma Medical Devices

Annex A Annex E Annex F

Complaint Reason Annex E IMDRF Code Description
IMDRF Code and Term IMDRF Code and Term IMDRF Code and Term
No patient involvement or, no observable clinical
Broken E2403 No Clinical Signs, F26 No Health
A0401 Break symptoms or a change in symptoms is identified in the
Component Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
Brush Broken A0401 Break symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
patient.
A24 Adverse Event No patient involvement or, no observable clinical
F26 No Health
Burning Without Identified Device E1705 Burning Sensation symptoms or a change in symptoms is identified in the
Consequences or Impact
or Use Problem patient.
No patient involvement or, no observable clinical
A04 Material Integrity E2403 No Clinical Signs, F26 No Health
Cap Defective symptoms or a change in symptoms is identified in the
Problem Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
A04- Material Integrity E2403 No Clinical Signs, F26 No Health
Cap Integrity symptoms or a change in symptoms is identified in the
Problem Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
Cap Leaking A0504 Leak/Splash symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
A0409 Material E2403 No Clinical Signs, F26 No Health
Cloudy symptoms or a change in symptoms is identified in the
Opacification Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
A030208 Unexpected E2403 No Clinical Signs, F26 No Health
Color symptoms or a change in symptoms is identified in the
Color Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
A0201 Product Quality E2403 No Clinical Signs, F26 No Health
Component Faulty symptoms or a change in symptoms is identified in the
Problem Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
Component A020602 Component E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
Missing Missing Symptoms or Conditions Consequences or Impact
patient.
A24 Adverse Event Health effect appears to have occurred but there is not yet
E2401 Insufficient F24 Insufficient
Condition Worse Without Identified Device enough information available to classify the clinical signs,
Information Information
or Use Problem symptoms and conditions.

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CONTROLLED DOCUMENT 12.1.19-GREF-2 Status: Effective Effective Date: 06/May/2022

BAUSCH + LOMB 12.1.19-GREF-2

Global Reference Document Revision: 1
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 3 of 8
Effects) for Pharma Medical Devices

Annex A Annex E Annex F

Complaint Reason Annex E IMDRF Code Description
IMDRF Code and Term IMDRF Code and Term IMDRF Code and Term
A030202 Coagulation in No patient involvement or, no observable clinical
Consistency/ E2403 No Clinical Signs, F26 No Health
Device or Device symptoms or a change in symptoms is identified in the
Viscosity Symptoms or Conditions Consequences or Impact
Ingredient patient.
No patient involvement or, no observable clinical
Container E2403 No Clinical Signs, F26 No Health
A0401 Break symptoms or a change in symptoms is identified in the
Damaged Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
A020602 Component E2403 No Clinical Signs, F26 No Health
Container Empty symptoms or a change in symptoms is identified in the
Missing Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
Counterfeit A27 Appropriate E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
Product Term/Code Not Available Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
Customer A27 Appropriate E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
Suggestion Term/Code Not Available Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
Damaged A0401 Break symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
patient.
A18 Contamination E2403 No Clinical Signs, No patient involvement or, no observable clinical
Debris F26 No Health
/Decontamination Symptoms or Conditions symptoms or a change in symptoms is identified in the
Consequences or Impact
Problem patient.
Defect Primary No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
Packaging A0205 Packaging Problem symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
Material patient.
Defect Secondary No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
Packaging A0205 Packaging Problem symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
Material patient.
Defect No patient involvement or, no observable clinical
A0201 Product Quality E2403 No Clinical Signs, F26 No Health
Tablet/Capsule/ symptoms or a change in symptoms is identified in the
Problem Symptoms or Conditions Consequences or Impact
Soft Gels patient.
No patient involvement or, no observable clinical
Device A0201 Product Quality E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
Malfunction Problem Symptoms or Conditions Consequences or Impact
patient.

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CONTROLLED DOCUMENT 12.1.19-GREF-2 Status: Effective Effective Date: 06/May/2022

BAUSCH + LOMB 12.1.19-GREF-2

Global Reference Document Revision: 1
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 4 of 8
Effects) for Pharma Medical Devices

Annex A Annex E Annex F

Complaint Reason Annex E IMDRF Code Description
IMDRF Code and Term IMDRF Code and Term IMDRF Code and Term
No patient involvement or, no observable clinical
Difficult to A0201 Product Quality E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
Dispense Problem Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
A051104 Difficult to Open E2403 No Clinical Signs, F26 No Health
Difficult to Open symptoms or a change in symptoms is identified in the
or Close Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
A030208 Unexpected E2403 No Clinical Signs, F26 No Health
Discoloration symptoms or a change in symptoms is identified in the
Color Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
A0408 Material E2403 No Clinical Signs, F26 No Health
Disintegration symptoms or a change in symptoms is identified in the
Disintegration Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
Dispenser A0201 Product Quality E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
Defective Problem Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
A0201 Product Quality E2403 No Clinical Signs, F26 No Health
Dried symptoms or a change in symptoms is identified in the
Problem Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
Drop Size A0201 Product Quality E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
Performance Problem Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
A0201 Product Quality E2403 No Clinical Signs, F26 No Health
Dry Pads / Wipes symptoms or a change in symptoms is identified in the
Problem Symptoms or Conditions Consequences or Impact
patient.
E2403 No Clinical Signs, No patient involvement or, no observable clinical
A0201 Product Quality F26 No Health
Dryness Symptoms or Conditions symptoms or a change in symptoms is identified in the
Problem Consequences or Impact
patient.
No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
Efficacy A0105 Lack of Effect symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
patient.
F26 No Health No patient involvement or, no observable clinical
Empty Primary A020602 Component E2403 No Clinical Signs,
Consequences or Impact symptoms or a change in symptoms is identified in the
Packaging Missing Symptoms or Conditions
patient.

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CONTROLLED DOCUMENT 12.1.19-GREF-2 Status: Effective Effective Date: 06/May/2022

BAUSCH + LOMB 12.1.19-GREF-2

Global Reference Document Revision: 1
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 5 of 8
Effects) for Pharma Medical Devices

Annex A Annex E Annex F

Complaint Reason Annex E IMDRF Code Description
IMDRF Code and Term IMDRF Code and Term IMDRF Code and Term
F26 No Health No patient involvement or, no observable clinical
Empty Secondary A020602 Component E2403 No Clinical Signs,
Consequences or Impact symptoms or a change in symptoms is identified in the
Packaging Missing Symptoms or Conditions
patient.
F26 No Health No patient involvement or, no observable clinical
A150101 Activation E2403 No Clinical Signs,
Failure to activate Consequences or Impact symptoms or a change in symptoms is identified in the
Failure Symptoms or Conditions
patient.
F26 No Health No patient involvement or, no observable clinical
A140304 E2403 No Clinical Signs,
Fill Volume Consequences or Impact symptoms or a change in symptoms is identified in the
Volume Accuracy Problem Symptoms or Conditions
patient.
No patient involvement or, no observable clinical
A140304 E2403 No Clinical Signs, F26 No Health
Fill Volume OOS symptoms or a change in symptoms is identified in the
Volume Accuracy Problem Symptoms or Conditions Consequences or Impact
patient.
A18 Contamination No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
Foreign Matter /Decontamination symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
Problem patient.
No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
Functionality A05 Mechanical Problem symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
patient.
An inflammatory reaction usually caused by infectious
A24 Adverse Event
Granulomatous F11 Minor Injury/ Illness / organisms, foreign bodies, or cholesterol deposits. It is
Without Identified Device E2317 Granuloma
Nodules Impairment characterized by the presence of epithelioid histiocytes
or Use Problem
and chronic inflammation.
No patient involvement or, no observable clinical
Hard to Squeeze A0201 Product Quality E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
Tube Problem Symptoms or Conditions Consequences or Impact
patient.
A24 Adverse Event
F11 Minor Injury/ Illness /
Infection Without Identified Device E0818 Eye Infections An infection of any part of the eye, including the eyelid.
Impairment
or Use Problem
A2101 Device No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
Labeling Markings/Labelling symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
Problem patient.
A2101 Device No patient involvement or, no observable clinical
Labeling E2403 No Clinical Signs, F26 No Health
Markings/Labelling symptoms or a change in symptoms is identified in the
Incorrect/Illegible Symptoms or Conditions Consequences or Impact
Problem patient.

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CONTROLLED DOCUMENT 12.1.19-GREF-2
BAUSCH + LOMB
Global Reference Document
Title: IMDRF Codes Annexes A, E and F (Problem and Health
Effects) for Pharma Medical Devices
Annex A
Complaint Reason
IMDRF Code and Term
A2101 Device
Labeling Missing Markings/Labelling
Problem
Lack of Effect A0105 Lack of Effect
Leakage A0504 Leak/Splash
A2101 Device
Lot/Expiry Date
Markings/Labelling
Issue
Problem
Missing Unit(s)
A020602 Component
from Secondary
Missing
Packaging
A02 Manufacturing,
Mix up Packaging or Shipping
Problem
A1409 Obstruction of
Needle Clogged
Flow
A27 Appropriate
Not Classified
Term/Code Not Available
Not Spraying A050301 Failure to Eject
Odor A0301 Device Emits Odor
A27 Appropriate
Other
Term/Code Not Available
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>
Status: Effective Effective Date: 06/May/2022
12.1.19-GREF-2
Revision: 1
Page 6 of 8
Annex E Annex F
Annex E IMDRF Code Description
IMDRF Code and Term IMDRF Code and Term
No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
patient.
REF-000338683 < > Rev 1 >
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CONTROLLED DOCUMENT 12.1.19-GREF-2 Status: Effective Effective Date: 06/May/2022

BAUSCH + LOMB 12.1.19-GREF-2

Global Reference Document Revision: 1
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 7 of 8
Effects) for Pharma Medical Devices

Annex A Annex E Annex F

Complaint Reason Annex E IMDRF Code Description
IMDRF Code and Term IMDRF Code and Term IMDRF Code and Term
No patient involvement or, no observable clinical
A020503 Unsealed Device E2403 No Clinical Signs, F26 No Health
Package Opened symptoms or a change in symptoms is identified in the
Packaging Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
Packaging A0205 Packaging Problem symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
Plunger Jammed A05 Mechanical Problem symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
patient.
A030203 Precipitate in No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
Precipitate Device or Device symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
Ingredient patient.
No patient involvement or, no observable clinical
Premature A150103 Premature E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
activation Activation Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
Product Broken A0401 Break symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
A0201 Product Quality E2403 No Clinical Signs, F26 No Health
Product Defect symptoms or a change in symptoms is identified in the
Problem Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
A020602 Component E2403 No Clinical Signs, F26 No Health
Product Missing symptoms or a change in symptoms is identified in the
Missing Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
Pump Broken (or E2403 No Clinical Signs, F26 No Health
A050301 Failure to Eject symptoms or a change in symptoms is identified in the
Functionality) Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
A0201 Product Quality E2403 No Clinical Signs, F26 No Health
Reconstitution symptoms or a change in symptoms is identified in the
Problem Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
SDU - Sharp Edges E2403 No Clinical Signs, F26 No Health
A051102 Sharp Edges symptoms or a change in symptoms is identified in the
at the Opening Symptoms or Conditions Consequences or Impact
patient.

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CONTROLLED DOCUMENT 12.1.19-GREF-2 Status: Effective Effective Date: 06/May/2022

BAUSCH + LOMB 12.1.19-GREF-2

Global Reference Document Revision: 1
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 8 of 8
Effects) for Pharma Medical Devices

Annex A Annex E Annex F

Complaint Reason Annex E IMDRF Code Description
IMDRF Code and Term IMDRF Code and Term IMDRF Code and Term
No patient involvement or, no observable clinical
A020504 Tear, Rip or Hole E2403 No Clinical Signs, F26 No Health
Seal Broken symptoms or a change in symptoms is identified in the
in Device Packaging Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
A020503 Unsealed Device E2403 No Clinical Signs, F26 No Health
Seal Integrity symptoms or a change in symptoms is identified in the
Packaging Symptoms or Conditions Consequences or Impact
patient.
An inflammatory process affecting the skin. Signs include
A24 Adverse Event
E1720 Skin Inflammation/ F26 No Health red rash, itching, and blister formation. Representative
Skin Irritated Without Identified Device
Irritation Consequences or Impact examples are contact dermatitis, atopic dermatitis, and
or Use Problem
seborrheic dermatitis.
No patient involvement or, no observable clinical
Stopped A0201 Product Quality E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
Dispensing Problem Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
Tamper Evident A0205 packaging problem E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
Feature Symptoms or Conditions Consequences or Impact
patient.
A24 Adverse Event No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
Taste Without Identified Device symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
or Use Problem patient.
No patient involvement or, no observable clinical
Texture A0201 Product Quality E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
(Ointment) Problem Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
Tip/Cap/Actuator A020602 Component E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
Missing Missing Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
Tube Cracked / E2403 No Clinical Signs, F26 No Health
A0404 Crack symptoms or a change in symptoms is identified in the
Split Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
E2403 No Clinical Signs, F26 No Health
Tube Integrity A0405 Degraded symptoms or a change in symptoms is identified in the
Symptoms or Conditions Consequences or Impact
patient.
No patient involvement or, no observable clinical
User/Handling A23 Use of Device E2403 No Clinical Signs, F26 No Health
symptoms or a change in symptoms is identified in the
Error Problem Symptoms or Conditions Consequences or Impact
patient.

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CONTROLLED DOCUMENT 12.1.19-GREF-2 Status: Effective Effective Date: 06/May/2022

BAUSCH + LOMB 12.1.19-GREF-2

Global Reference Document Revision: 1
Title: IMDRF Codes Annexes A, E and F (Problem and Health Page 9 of 8
Effects) for Pharma Medical Devices

Revisions

Rev: 1 Author: Sarum Sreng CR-000290448

Description of Changes: ▪ New document

Implementation Instructions: Upon Document Approval

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CONTROLLED DOCUMENT
SIGNATURE PAGE
Document Name :REF-000338683

Document Title :IMDRF Codes Annexes A E and F (Problem and Health Effects) for
Pharma Medical Device

Document ID :12.1.19-GREF-2

Signed By Date (GMT) Justification

Proud Tes 03/May/2022 Author Confirmation

15:10:58

Graham Meredith 03/May/2022 Functional Approval

21:41:38

Garrett Tricia M 06/May/2022 Quality Approval

12:19:59

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