ISO 13485 Medical Device File requirements for IVD

#1
Hello all, I am in charge of transitioning our QMS from ISO 9001 to ISO 13485. To give some background, we manufacture immunochemical reagents and also the IVDs that they are used in.

ISO 13485 clause 4.2.3 states that we need to maintain files to demonstrate conformity to the ISO and regulatory requirements (for example CE marking). Would this also apply to our immunochemical reagents, that are not defined as medical devices?

I assume that IVDs are technically a medical device, as they are a subset?
 
Elsmar Forum Sponsor

Ajit Basrur

Staff member
Admin
#2
Hello all, I am in charge of transitioning our QMS from ISO 9001 to ISO 13485. To give some background, we manufacture immunochemical reagents and also the IVDs that they are used in.

ISO 13485 clause 4.2.3 states that we need to maintain files to demonstrate conformity to the ISO and regulatory requirements (for example CE marking). Would this also apply to our immunochemical reagents, that are not defined as medical devices?

I assume that IVDs are technically a medical device, as they are a subset?
Welcome to the Cove :bigwave:

Yes, IVDs are considered medical devices.

Refer Overview of IVD Regulation for more information.
 
Thread starter Similar threads Forum Replies Date
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12
K ISO 13485:2016, Clause 4.2.3 Medical Device File ISO 13485:2016 - Medical Device Quality Management Systems 4
R ISO 13485 and QMS related concepts Training - Small medical device startup company ISO 13485:2016 - Medical Device Quality Management Systems 9
R ISO 9001 versus ISO 13485 for Suppliers to Medical Device Companies ISO 13485:2016 - Medical Device Quality Management Systems 2
C Medical device manufacturing (class 2 ISO 13485:2016) - Is a Deviation allowed? Other Medical Device Related Standards 5
M Start-Up Company looking for ISO 13485 Certification Body and Medical Device CE Mark Notified Body Registrars and Notified Bodies 6
Sidney Vianna FDA plans to use ISO 13485 for Medical Devices Regulation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
J Medical Devices in Japan - Conformity of QMS to ISO 13485 Japan Medical Device Regulations 1
M Are Medical device Raw material suppliers required to be ISO 13485 certified ISO 13485:2016 - Medical Device Quality Management Systems 13
B ISO 13485 certification advantages when I certify a Class 2a medical device CE Marking (Conformité Européene) / CB Scheme 12
Sam Lazzara Medical Device File Requirements (ISO 13485 Cl. 4.2.3) ISO 13485:2016 - Medical Device Quality Management Systems 11
H ISO 14971 vs. IEC 62304 vs. 98/79/EC vs. ISO 13485 (Software Medical Device) ISO 14971 - Medical Device Risk Management 1
S ISO 13485 Definitions - Medical Device Component Supplier ISO 13485:2016 - Medical Device Quality Management Systems 4
S Trying to understand 7.2.1(d) of ISO 13485 - Medical Device User Training ISO 13485:2016 - Medical Device Quality Management Systems 8
somashekar ISO 13485. Is it worth to the Medical Device Industry. Imported Legacy Blogs 0
Colin Application of ISO 13485 to a Medical Device distributor ISO 13485:2016 - Medical Device Quality Management Systems 5
O Unique situation regarding a Veterinary Medical Device and ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 4
K ISO 13485 requirements for Stand Alone Medical Device Software (Class II a) ISO 13485:2016 - Medical Device Quality Management Systems 1
M ISO 13485 and Class 1 Medical Device - FDA thinking ISO 13485:2016 - Medical Device Quality Management Systems 14
Q Need Outsourced ISO 13485/FDA Internal Auditor for a Medical Device Company Internal Auditing 3
J Pre-Revenue Medical Device Company ISO 13485 Audit ISO 13485:2016 - Medical Device Quality Management Systems 1
K ISO 9001 vs. ISO 13485 Registration - Approximately 1/3 of our customers are medical ISO 13485:2016 - Medical Device Quality Management Systems 4
S Please help on ISO 13485 medical device related services Other Medical Device Related Standards 1
X Help with ISO 13485 Clause 8.3 "Rework" as applicable to Medical Device Servicing ISO 13485:2016 - Medical Device Quality Management Systems 39
X Help with ISO 13485 Clause 6.4 as it applies to Medical Device Servicing ISO 13485:2016 - Medical Device Quality Management Systems 25
G The Documentation of Data Analysis for an ISO 13485 Medical Device Submission ISO 13485:2016 - Medical Device Quality Management Systems 9
K Building Heavy Pollution Factory next to Medical Device Factory (ISO 13485) ISO 13485:2016 - Medical Device Quality Management Systems 6
J Confused about application of ISO 13485 - Manufacturer of Medical Equipment & Device ISO 13485:2016 - Medical Device Quality Management Systems 14
U ISO 13485 mandatory for a factory making Medical Devices for EU? EU Medical Device Regulations 6
P Removing Detection from DFMEA - Medical Device company using ISO 13485 FMEA and Control Plans 3
B ISO 13485 and Medical Device Manufacturing Outsourcing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Problems implementing ISO 13485 for Software-Only Medical Device Manufacturers? ISO 13485:2016 - Medical Device Quality Management Systems 4
B ISO 13485 Class I Medical Device Design Exclusion ISO 13485:2016 - Medical Device Quality Management Systems 10
D Are we required to obtain ISO-13485 to act as a Sales Channel for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 3
S Medical Device/IVD Manufacturer Supplier Requirements - Compliant to ISO 13485?? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Medical Device Class IIa Nonsterile ISO 13485 Alternatives ISO 13485:2016 - Medical Device Quality Management Systems 3
S Distributor for Products used in Medical Laboratories - Is ISO 13485 Required? ISO 13485:2016 - Medical Device Quality Management Systems 11
T MDD (Medical Device Directive) and ISO 13485 and a lot of Questions EU Medical Device Regulations 3
C Applicability of ISO 13485 for Medical TESTING Company ISO 13485:2016 - Medical Device Quality Management Systems 3
F Quality Manual Template for ISO 13485 - Small Contract Medical Device Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 3
B Class IIb Medical Device using Annex II route - Need to Update ISO 13485 Scope? ISO 13485:2016 - Medical Device Quality Management Systems 2
B Medical Device Files - ISO 13485 section 4.2.1 requirements ISO 13485:2016 - Medical Device Quality Management Systems 1
L ISO 13485 - Overwhelmed by various Medical Device standards ISO 13485:2016 - Medical Device Quality Management Systems 2
Y Preparing an audit plan for ISO 13485, MDD and CMDR for medical imaging company Imported Legacy Blogs 8
Marc ISO 13485 - Medical Device Quality Management System Standard ISO 13485:2016 - Medical Device Quality Management Systems 30
F Vendor (supplier) for ISO 13485 Medical Devices Co. minimum QA System ISO 13485:2016 - Medical Device Quality Management Systems 3
Marc ISO 13485 and ISO 14971 - Medical Devices and Related Forums Qualification and Validation (including 21 CFR Part 11) 0
Marc ISO 13485 and ISO 14971 - Medical Devices and Related Forums Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
Marc ISO 13485, ISO 14971 and other Medical Device Related Forums 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Marc ISO 13485 and ISO 14971 - Medical Devices and Related Forums US Food and Drug Administration (FDA) 0

Similar threads

Top Bottom