Definition of disease as per medical device defintion

sriramsl

Involved In Discussions
#1
Dear all

The definition of Medical Device uses the term "disease" - as in "diagnosis, prevention, monitoring, prediction, prognosis, treatment o ralleviation of disease". I understand that normally we refer to disease as given in dictionary "any harmful deviation from the normal structural or functional state of an organism, generally associated with certain signs and symptoms and differing in nature from physical injury".. This is clear and I do not have any confusion here.

However, I would like to know is there any definition of 'disease" given by any Regulation (particularly EU Regulation) in the context of Medical Device definition.

This question has arisen, because one the companies that has designed a "customised software application that depicts the medical condition of a patient and the treatment procedure - particularly sugical procedure - in a video form - to be used by clinician to explain the medical procedure to the patients, and this company claims that it is a medical device, since it "alliviates the anxiety or fear of a patient of the impending surgery" and considers "anxiety or fear as a disease"

From the dictionary definition quoted above, I do not think that anxiety will fall under the definition of disease, though it may be considered as 'emotional or psychological disease or disorder" .

Hence I will appreciate if anyone can guide me to the definition of "disease" as per the medical device definition

Thanks and Regards
Sriram
 
Elsmar Forum Sponsor

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#2
First since your device is completely passive and educational only I think whichever pathway chosen regulators wont ask too many questions about it.

Since the company claims it treats anxiety, how does the evidence for that claim discuss anxiety? Do you have acess to that?
 

Al_Z1

Starting to get Involved
#4
Hm, I'd try to ask this company about compliance of their anxiety or fear as a disease with The International Statistical Classification of Diseases and Related Health Problems. 11th revision (ICD-11)...As blunt, as possible:).
 

sriramsl

Involved In Discussions
#5
First since your device is completely passive and educational only I think whichever pathway chosen regulators wont ask too many questions about it.

Since the company claims it treats anxiety, how does the evidence for that claim discuss anxiety? Do you have acess to that?
Thanks Ed for the reply....

My question is - what is the definition of disease as per Medical device definition. Will appreciate if you can answer that

Thanks
Sriram
 

sriramsl

Involved In Discussions
#6
Hm, I'd try to ask this company about compliance of their anxiety or fear as a disease with The International Statistical Classification of Diseases and Related Health Problems. 11th revision (ICD-11)...As blunt, as possible:).
Thanks AI_Z1 - let me chek the ICD-11 for definition of disease
However, how does Medical device definition - define disease?

Thanks
Sriram
 

sriramsl

Involved In Discussions
#8
Hm, I'd try to ask this company about compliance of their anxiety or fear as a disease with The International Statistical Classification of Diseases and Related Health Problems. 11th revision (ICD-11)...As blunt, as possible:).
Dear AI_Z1
Thank you for referring me to ICD-11
There is a category "Anxiety or fear-related disorders, unspecified" with code 6B0Z and Anxiety or fear-related disorders, specified with a code 6B0Y..
So the Anxiety or Fear due to the impending medical treatment can be taken in to this category of Mental "disease" and hence the product can be classified under Medical Device with an intended purpose of "Alleviating the mental disease of anxiety due to impending medical treatment"
 

sriramsl

Involved In Discussions
#9
I haven't seen a definition of 'disease' in device regulation/guidance at an EU level.

It is defined in UK's medicines regulations:
"'Disease' includes any injury, ailment, or adverse condition, whether of body or mind." (Human Medicines Regulations 2012, SI 2012/1916, reg 8(1))​

This is UK's implementation of Directive 2001/83/EC (which doesn't contain a definition!)

Thank you dgrainger
Since the UK medicines regulation identifies "mind" in the definition of disease, then the anxiety can be taken as a mental disease....

Thanks
Regards
Sriram
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#10
Stop thinking disease. A broken bone isn't a disease but it is a medical condition. Pain isn't a disease, but try to put pain reliever on a home brew of herbs you made and sell it.

A device that reduces anxiety is a medical claim. Anxiety is defined here as a disorder. Table 3.15, DSM-IV to DSM-5 Generalized Anxiety Disorder Comparison - Impact of the DSM-IV to DSM-5 Changes on the National Survey on Drug Use and Health - NCBI Bookshelf (nih.gov)

What this means is doctors diagnose this "disease" or condition and treat it using drugs and devices to help. If you claim you can help, you are now tied into treating anxiety. That requires evidence.
 
Thread starter Similar threads Forum Replies Date
D Definition of Sub-supplier in chemicals IATF 16949 - Automotive Quality Systems Standard 3
C Is there a definition of accessories for medical devices in China? China Medical Device Regulations 1
T Software Unit definition - IEC 62304 - Medical Device Software Life Cycle Processes 3
T Software user interface - definition of hazards ISO 14971 - Medical Device Risk Management 15
K Definition and Example of Shelf life, Expiry date, Expected service life and Lifetime EU Medical Device Regulations 6
J Machinery Directive : Emergency stop clause : definition of 'portable' or 'hand-guided' machinery Other ISO and International Standards and European Regulations 0
C Definition of "Manufacturing date" Other Medical Device Regulations World-Wide 4
S Definition of sterile condition EU Medical Device Regulations 4
JoCam Definition of Accessory EU Medical Device Regulations 2
K Definition of SAE under MDR EU Medical Device Regulations 3
C Narrow definition of IMTE or calibration possible? ISO 13485:2016 - Medical Device Quality Management Systems 8
G Medical Device - Borderline/Definition EU Medical Device Regulations 0
S Configuration Item definition question AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
J Definition Outsourced process - Clear definition - 13485 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 5
M Definition Aviation - Definition of Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
J Where is the definition of a critical supplier? ISO 13485:2016 - Medical Device Quality Management Systems 5
A DMDIV-Variants : definition and technical documentation CE Marking (Conformité Européene) / CB Scheme 4
O Clarifying FDA definition of "finished device" and “capable of functioning” 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
L 'Distributor' definition & MDR/MSR relationship EU Medical Device Regulations 3
D Definition of equipment for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
M ISO 13485:2016 Complaint Definition Clarity Customer Complaints 2
DuncanGibbons Technical Data Package vs Digital Product Definition APQP and PPAP 0
S Definition of "worldwide" in view of IATF 16949 and Product conformity IATF 16949 - Automotive Quality Systems Standard 3
S Importer definition EU Medical Device Regulations 0
A Software as Medical Device (SaMD) definition and its applicability Other Medical Device and Orthopedic Related Topics 4
M Definition of Done - New Product Phase to the sustaining phase Manufacturing and Related Processes 3
M Help me improve the definition for internal PPM Manufacturing and Related Processes 3
D Tolerance definition based on expected Cp/cpk Reliability Analysis - Predictions, Testing and Standards 14
D BS EN 62304 - Medical-Relevant Data C.5 - Definition of IEC 62304 - Medical Device Software Life Cycle Processes 5
P Definition of production tooling in IATF16949 clause 8.5.1.6 IATF 16949 - Automotive Quality Systems Standard 4
J Sample size definition in an Automotive SMT pilot lot run Misc. Quality Assurance and Business Systems Related Topics 1
J Definition Defect Mapping - Here is my definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
D Definition of "Critical Laboratory Equipment"? General Measurement Device and Calibration Topics 1
Z Definitive definition of design? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
R Definition Key Supplier - Definition of Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 7
A Definition of customer in ITP (Inspection & Test Plan) Contract Review Process 3
F MEDDEV 2.7/1 rev 4 and MDR - Definition of Description of Principles of operation EU Medical Device Regulations 4
S Definition of "servicing activities" - Spinal Implants ISO 13485:2016 - Medical Device Quality Management Systems 4
T Custom made medical device MDD vs MDR definition CE Marking (Conformité Européene) / CB Scheme 12
C Function definition for DFMEA FMEA and Control Plans 1
W Key functional characteristic definition - Tolerances and Deviations Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
Marc Definition Waiver - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
M Informational MHRA guidance – Assistive technology: definition and safe use Medical Device and FDA Regulations and Standards News 0
R Critical suppliers (Definition of) and MDSAP (Medical Device Single Audit Program) ISO 13485:2016 - Medical Device Quality Management Systems 22
Pancho Definition Quality Assurance Program - Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
M Inputs on definition of very similar processes for multi site audit sample - IAF MD1 2018 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
U Hand-Held dosing device has no PATIENT - Interpretation of the PATIENT definition IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
L Medical Device Accessory - Health Canada guidance / definition on what an accessory is Canada Medical Device Regulations 3
C MDR Importer/Distributor Definition Questions EU Medical Device Regulations 29
G Medical Device "Immediate Container" Interpretation of Definition US Food and Drug Administration (FDA) 2

Similar threads

Top Bottom