Interpretation of significant change - material change

kate

Registered
#1
Hi!
I have a couple of questions about Flowchart F (materials change in non-IVDD device) of Health Canada Guidance for the Interpretation of Significant Change of a Medical Device.

1) is the term "contact" used in the flowchart referring to both direct and indirect?
2) if the device not intended to be absorbed by the body or to remain in the body for at least 30 consecutive days, but the altered material is in contact with body tissues or fluid, change to the "specification" has to be considered. What is your interpretation of this "specification"? Is it specification of the material or of the device or of the part?
If there is a change to the material, in which instances there will be no change to the specification?

Thank you for your help!!
 
Last edited:
Elsmar Forum Sponsor

shimonv

Trusted Information Resource
#2
Hi Kate,
Since regulatory is all about risk based approach it would be helpful to know what the device is and what is the intended change.

1. Since no interpretation is offerer in this guidance, I would take the term "Contact" as referring to direct contact. However, if indirect contact is likely to occur (based on risk management or usability study) and it is significant from risk based approach, I will regard "contact" as referring to both direct and indirect contact.
2. You need to ask the question "have the specification changed?" for every material that is effected by the change.
3. I would say in most cases a change in material means a change in specification. In cases where the material composition is insignificant (for example, washers for screws) and therefore not specified in the drawings - you could say that specification has not changed.

Shimon
 

kate

Registered
#3
Hi Kate,
Since regulatory is all about risk based approach it would be helpful to know what the device is and what is the intended change.

1. Since no interpretation is offerer in this guidance, I would take the term "Contact" as referring to direct contact. However, if indirect contact is likely to occur (based on risk management or usability study) and it is significant from risk based approach, I will regard "contact" as referring to both direct and indirect contact.
2. You need to ask the question "have the specification changed?" for every material that is effected by the change.
3. I would say in most cases a change in material means a change in specification. In cases where the material composition is insignificant (for example, washers for screws) and therefore not specified in the drawings - you could say that specification has not changed.

Shimon
Thanks for your input. It would be material change from the current material to nitinol. The device in question is a catheter with limited exposure (<24hours).
 
Thread starter Similar threads Forum Replies Date
E FDA Significant Change Interpretation - Guidance Document EU Medical Device Regulations 2
T Health Canada Class III/IV "Significant Change" guidance interpretation Canada Medical Device Regulations 2
O What is your interpretation of a Significant Method Change Manufacturing and Related Processes 7
B Sanctioned interpretation #10 - ISO 17025 IATF 16949 - Automotive Quality Systems Standard 2
somashekar Interpretation of 6.3 Infrastructure in the context of new machines ISO 13485:2016 - Medical Device Quality Management Systems 7
Q Contingency plan - IATF Sanctioned Interpretation 17 IATF 16949 - Automotive Quality Systems Standard 4
U MDD Article 12/ MDr Article 22 interpretation EU Medical Device Regulations 2
R MDR, Annex I, 23.1 Interpretation - IFU on the website EU Medical Device Regulations 5
M MDR Article 22 Interpretation EU Medical Device Regulations 3
I Interpretation of the MDR GSPR 23.4 (u) EU Medical Device Regulations 2
D IATF16949 - Interpretation of Customer Requirements clauses IATF 16949 - Automotive Quality Systems Standard 3
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P MDR Rule 10 interpretation - Active Device EU Medical Device Regulations 6
Q % Study variation low, % tolerance high - GR&R Interpretation help Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
A Interpretation with regards to Ppk > Cpk Capability, Accuracy and Stability - Processes, Machines, etc. 14
A OHSAS 18001 external auditor finding personal interpretation? Occupational Health & Safety Management Standards 5
A OEM branding - My interpretation of the LVD Directive makes us a manufacturer CE Marking (Conformité Européene) / CB Scheme 3
P Average Peel Strength - Interpretation of BS EN 868-5:2018 and ASTM F0088/F0088M Other Medical Device Related Standards 2
B ISO 50001 Interpretation of section 3.3.9 (Outsourcing) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
R MDR Software Rule 11 Formal Interpretation EU Medical Device Regulations 7
A IATF Sanctioned Interpretation No. 7 - Type and Extent of Control (supplemental) IATF 16949 - Automotive Quality Systems Standard 4
F Interpretation of MDR 2017/745 Article 23 - CE Mark Requirements EU Medical Device Regulations 8
U Hand-Held dosing device has no PATIENT - Interpretation of the PATIENT definition IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
G Medical Device "Immediate Container" Interpretation of Definition US Food and Drug Administration (FDA) 2
A Interpretation of Article 16 (2b) - Packaging, samples and Certificate EU Medical Device Regulations 10
D EU MDR Corrigendum Interpretation EU Medical Device Regulations 3
M Informational MDCG 2019-3 Interpretation of Article 54(2)b – Pre- market clinical evaluation consultation procedure with the involvement of expert panels Medical Device and FDA Regulations and Standards News 0
G EU MDR 2017/745 Rule 11 interpretation - Re-classification of a Software as Medical Device Other Medical Device Related Standards 0
JoshuaFroud Interpretation of Clause 5.5.2 in ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
qualprod P x I = Value interpretation for residual risk? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
T CSA Z299.3-85 Nuclear interpretation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
D VDA Trigger Matrix in the VDA 6.2 Manual - Interpretation and Use VDA Standards - Germany's Automotive Standards 3
B Interpretation of Customer Specific Requirements of Continental - Records Retention Customer and Company Specific Requirements 6
S Interpretation or Definition of ‘Once Every 5 Days’ ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
N What is the interpretation I-MR-R chart in this question? Statistical Analysis Tools, Techniques and SPC 1
E ME (Medical Equipment) Systems - IEC 60601-1 Clause 16.1 Interpretation IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
P IATF 16949 Cl. 7.1.5.2.1 "Calibration/Verification Records" Interpretation IATF 16949 - Automotive Quality Systems Standard 12
B Clarification on interpretation of some EN ISO 14971:2012 & IEC 62304:2006 req's ISO 14971 - Medical Device Risk Management 46
M IATF 16949 - 7.1.3.1 Plant, Facility, and Equipment Planning - Interpretation IATF 16949 - Automotive Quality Systems Standard 8
R Location Interpretation on Drawing - Hole to Hole? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
T TS 16949 Clause 7.4.1.2 and Sanctioned Interpretation IATF 16949 - Automotive Quality Systems Standard 12
D Interpretation of new IAQG ruling - Audit duration for nonconformance verification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
K Interpretation of IEC 60601-1-2 Electromagnetic Compatibility – Requirements & tests IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
S Heat Treatment - Soaking time interpretation Manufacturing and Related Processes 5
D Interpretation of DOE interaction plot Using Minitab Software 8
A Training material for interpretation & understanding Part 11 requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
L Interpretation of "Any or All"'? IEC 60601 - Medical Electrical Equipment Safety Standards Series 10
G Interpretation of phrase - "Direct Authority" EASA and JAA Aviation Standards and Requirements 5
pittmatj Brazil: Interpretation of RDC 185 Other Medical Device Regulations World-Wide 6
D What is your understanding or interpretation of TS16949 7.4.1.2 IATF 16949 - Automotive Quality Systems Standard 6

Similar threads

Top Bottom