Intended purpose for devices that might not fit the IP criteria

#1
I have a IVD accessory, a calibration plate for a qPCR machine. When trying to write the intended use, most of the points listed in Annex I 20.4.1 (c) aren't applicable.
It's easy to write when it's an assay and there's a specific analyte for a disease.

Is it OK to leave out the ones that don't apply?
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
dgrainger Informational DRAFT - Common specifications for the groups of products without an intended medical purpose listed in Annex XVI. EU Medical Device Regulations 0
A Intended Purpose on device label EU Medical Device Regulations 7
K Difference between intended purpose and intended use of the device EU Medical Device Regulations 9
thisby_ Intended Use vs. Intended Purpose vs. Intended by the Manufacturer - Doubts ISO 13485:2016 - Medical Device Quality Management Systems 9
F Multiple Intended Use Statements US Food and Drug Administration (FDA) 0
M Intended Use vs Actual Use and Scope of Risk Management EU Medical Device Regulations 8
P UDI on devices exclusively intended for retail point of sale EU Medical Device Regulations 3
J IEC 60601 Applied Part - Probes intended to be covered by sheaths IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
T Risks of failure to meet intended use ISO 14971 - Medical Device Risk Management 6
ernieto Intended use reagents EU Medical Device Regulations 6
J Significant change related to design and intended use EU Medical Device Regulations 3
U Intended use - Taiwan EU Medical Device Regulations 2
U Intended Users in IFU (Instructions for Use) EU Medical Device Regulations 5
G Same intended use devices - Technical file EU Medical Device Regulations 5
B IEC 60601 Cl. 8.4.3 - ME EQUIPMENT intended to be connected to a power source by a plug / Plug discharge IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
MDD_QNA We have a device with two intended uses and we want to remove one EU Medical Device Regulations 14
K Intended Use-Class I Self Certified - Intended Use and Indications for Use statements EU Medical Device Regulations 1
M Informational FDA order – All manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distr Medical Device and FDA Regulations and Standards News 0
W IEC 60601-1-2 Susceptibility/Immunity for device intended to be used in patient body IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
O FDA- CDRH - Design considerations for devices intended for home use US Food and Drug Administration (FDA) 1
O New stability - Yes or No - Similar product but for different intended use EU Medical Device Regulations 1
armani Definition Intended Results - What does "Intended Results" mean? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
I Medical Device - Bundled 510(k) for multiple intended uses Other US Medical Device Regulations 11
M Devices intended to administer medicinal products - MDD 93/43, Annex I, 7.3 EU Medical Device Regulations 1
Q The ability of computer software to satisfy the intended application ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
X IEC60601 Battery powered devices intended for measuring bio-impedance IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
P Updating a Medical Device's Intended Use Other US Medical Device Regulations 2
K Intended Use wording: What is suitable for the instruction manual? EU Medical Device Regulations 4
P Mandatory wording of Intended Use Other US Medical Device Regulations 2
Ronen E Proposed reclassification of Ultraviolet (UV) Lamps intended to tan the skin Other US Medical Device Regulations 1
B New 510k for change to Intended Use - Prescription to OTC 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
K Indication for Use/Intended Use/New Use - Different look but functionally the same 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Prescription or non-prescription -Labeling/intended use makes the distinction? Other US Medical Device Regulations 4
Ronen E Design Considerations for Devices Intended for Home Use (FDA guidance) US Food and Drug Administration (FDA) 0
I Confirmation of Computer Software to satisfy Intended Application Misc. Quality Assurance and Business Systems Related Topics 2
M 510k Predicates with different Intended Use Other US Medical Device Regulations 6
V Medical Device Intended Use Document - Risk Analysis Documentation Requirements ISO 14971 - Medical Device Risk Management 12
B Does a US FDA Class I (exempt) device require a Statement of Intended Use? Other US Medical Device Regulations 3
B Using Components not intended for Medical Devices Other US Medical Device Regulations 2
G Additional Intended Use Predicate 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
C Indications for Use vs. Intended Use in User Manual 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
P Excessive Temperature - Parts of equipment not intended to supply heat IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
G Cl 4.2, ISO 14971:2007 - Intended use & identification of characteristics related... ISO 14971 - Medical Device Risk Management 1
A Clause 8.5 Continual Improvement - What is intended by the standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
T A confusing Non-conformity - No defined QMS processes intended for 'Management' ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
G New intended use - Validation of a class IIb implantable (non-active) ISO 13485:2016 - Medical Device Quality Management Systems 5
Sidney Vianna Intended Applicability of the Aerospace 91XX Standards AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
T "Indication for Use" used in 510(k) - Indications for Use vs. Intended Use ISO 13485:2016 - Medical Device Quality Management Systems 7
Q ISO 9001 Clause 7.6 - Computer software to satisfy the intended application Records and Data - Quality, Legal and Other Evidence 8
S How to confirm the ability of computer software to satisfy the intended application? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2

Similar threads

Top Bottom