Information required about changing an off shelf part

E

Eyeclicker

#1
Hi,

We are changing an off shelf part with a new part of the same kind, its like replacing one T- joint with a new T- joint which is like one of a small piece of a puzzle. I would like to know whether it comes under minor or major design change and do we need to do the bio-compatibility and Age testing for the entire product.

Kindly help me with this problem.
 
Elsmar Forum Sponsor

Jim Wynne

Staff member
Admin
#2
Welcome to the Cove. :bigwave: You posted this same question in five different forums, which will cause confusion. I deleted the other four and left this one in what appears to be the correct forum.
 

Mark Meer

Trusted Information Resource
#3
Hi Eyeclicker.

The unsatisfying answer is: it depends.

Ultimately the assessment is up to you, and will depend on the nature of the product, and the role the replaced part plays.

Does replacing the part potentially invalidate previous biocompatibility testing? If so, then yes, you will have to revisit biocompatibility (which may or may not involve retesting).

Check out this FDA Guidance, and Health Canada Interpretation for some guidance on assessing the significance of the change.
 
Thread starter Similar threads Forum Replies Date
W MDR Annex I chapter 23.2 (q) - Information required on the label EU Medical Device Regulations 17
M Information Required in Certificate of Free Sale Other Medical Device Regulations World-Wide 6
M Is information required on more than one side of box? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Extent of information required in COC (aka C of C and Certificate of Conformance) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
M What information is required to all employees according to ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S Information required on camshaft machining Manufacturing and Related Processes 5
oldqamanager Purchase Order Revisions and PO Review - What information is required in a PO? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
P FIAT CSR (customer specific requirements) Required Manuals - Information wanted Customer and Company Specific Requirements 14
J Material Test Form - Example of the required information Document Control Systems, Procedures, Forms and Templates 4
R Risk assessment on IT containers and the information they contain IEC 27001 - Information Security Management Systems (ISMS) 4
O EN 301 489-1 and EN 301 489-17 - Where do we get the information of the Published versions? CE Marking (Conformité Européene) / CB Scheme 1
K Article 18: Implant Card and information to be communicated. EU Medical Device Regulations 5
K EU MDR Annex 1 Chapter III: Information in the Instructions for Use-23.4 (e) the performance characteristics of the device; EU Medical Device Regulations 1
A GMDN Registration Basic preliminary Information EU Medical Device Regulations 0
J Controlled information versus defined documents / records ISO 13485:2016 - Medical Device Quality Management Systems 3
A Medical device Reporting : Good Faith Effort for Additional information Other US Medical Device Regulations 2
P Cenelec updated standard information CE Marking (Conformité Européene) / CB Scheme 1
Richard Regalado Automotive News TISAX - VDA ISA (information security assessment) VDA Standards - Germany's Automotive Standards 5
JoCam False information provided for Medical Device Registration - What are the implications? Other Medical Device Related Standards 3
adir88 Information of safety can reduce risk now? ISO 14971 - Medical Device Risk Management 12
Richard Regalado What could go wrong with information: Ransomware statistics and facts (2018 to present) IEC 27001 - Information Security Management Systems (ISMS) 0
Q LOT or Serial Number Symbol not used when the information is contained in the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Information about Medical Device Test Laboratories Other Medical Device and Orthopedic Related Topics 4
C Missing routers/documented information Nonconformance and Corrective Action 5
MrTetris Unacceptable risk and information for safety ISO 14971 - Medical Device Risk Management 16
M Is Harmonised EN 1041 (Information Supplied By Manufacturer) Worth Looking At? EU Medical Device Regulations 7
P Predicate Device Information for 510(k) Submission Medical Device and FDA Regulations and Standards News 4
V IS/ISO/IEC 17025:2017 Clause 7, sub clause 7.11 Control of data and information management ISO 17025 related Discussions 1
A Medical Device Contract Manufacturing Requirements and Information - Help wanted ISO 13485:2016 - Medical Device Quality Management Systems 5
H Analog Pressure Gauge with no EN837 accuracy class information General Measurement Device and Calibration Topics 5
M Informational EU – MDCG 2019-12 Designating authority’s final assessment form: Key Information Medical Device and FDA Regulations and Standards News 0
G What information to put on measurement Dimensional Results APQP and PPAP 7
L MDR - Information in the instructions for use - clausole 23.4.(z) EU Medical Device Regulations 2
K AS9100D Clause 7.5.2.a) - What is considered to be "documented information"? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
A Information on good laboratory practices (GLP) for the non-medical or food industry wanted Manufacturing and Related Processes 1
I What kind of information needs to be in a calibration record? General Measurement Device and Calibration Topics 25
M Informational TGA – Medical device patient information leaflets and implant cards Medical Device and FDA Regulations and Standards News 0
Q AS9120 7.5.3.2 Control of Documented Information - Audit Nonconformance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20
G Posting Measuring Equipment Accuracy for User Information General Measurement Device and Calibration Topics 4
J EC REP information and CE Mark - Component of a system that is not a medical device EU Medical Device Regulations 2
M Informational EU – Medical devices: Implementation of Regulation (EU) 2017/745 on medical devices (MDR) – Information from the Irish and German delegations Medical Device and FDA Regulations and Standards News 0
D ISO 9001:2015 Clause 8.4.3 "Information for External Providers" buying from online retailers. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B Practical ideas for information labelling in healthcare environment IEC 27001 - Information Security Management Systems (ISMS) 2
M Informational US FDA – Historical Information about Device Emergency Use Authorizations Medical Device and FDA Regulations and Standards News 0
M Informational US FDA – Patient Preference Information (PPI) in Medical Device Decision-Making Medical Device and FDA Regulations and Standards News 0
M Informational USFDA final guidance – Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions Medical Device and FDA Regulations and Standards News 0
R Where to get information - M6 per WA900 Manufacturing and Related Processes 1
M Informational FDA Posts Information about Ethylene Oxide Sterilization and Medical Devices Medical Device and FDA Regulations and Standards News 0
L VDA 1 Documented Information and Retention (new revision 4, August 2018) VDA Standards - Germany's Automotive Standards 0
R Publication of user information in manufacturer website for medical devices Other Medical Device Regulations World-Wide 2

Similar threads

Top Bottom