Application of ISO 13485 to a Medical Device distributor

Colin

Quite Involved in Discussions
#1
I have been contacted by an organisation in the UK that buys in and distributes medical equipment from abroad. The manufacturers have ISO 13485 certification and the distributor has certification to ISO 9001 - albeit non-UKAS accredited.

They have tendered for a large contract and been told that they must also be certificated to ISO 13485.

My knowledge does not stretch to medical devices but I was under the impression that it was a manufacturing standard and as such, not necessary for a distributor. Can anyone help me on this please?
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
ISO 13485 is not solely a manufacturing standard.

However, in general it's not necessary for a distributor if the devices they distribute are already regulatorily conforming, including manufacturer registration / product listing / in-regulatory-jurisdiction representation / appropriate design/quality/manufacturing documentation / system for reporting adverse events as required, in the intended market.

Manufacturer ISO 13485 certification is a necessary element, of course, and you mention that's in place.

Are all of the devices in question appropriately CE Marked, and otherwise in conformance along with their manufacturers in all other respects?

And of course, the buying organization may have decided to impose its own requirement, just to "raise the bar" a bit for its supply chain.
 

Colin

Quite Involved in Discussions
#3
ISO 13485 is not solely a manufacturing standard.

However, in general it's not necessary for a distributor if the devices they distribute are already regulatorily conforming, including manufacturer registration / product listing / in-regulatory-jurisdiction representation / appropriate design/quality/manufacturing documentation / system for reporting adverse events as required, in the intended market.

Manufacturer ISO 13485 certification is a necessary element, of course, and you mention that's in place.

Are all of the devices in question appropriately CE Marked, and otherwise in conformance along with their manufacturers in all other respects?

And of course, the buying organization may have decided to impose its own requirement, just to "raise the bar" a bit for its supply chain.
Thanks for the clarification - I think your last sentence is the most significant one in this case, this particular organisation is looking to apply its own criteria.
 

pkost

Trusted Information Resource
#4
MIREGMGR is correct, ISO 13485 is not required for distributors or importers in the EU, the standard relates to the manufacture of devices and therefore is inappropriate. (in fact the directive does not mention any obligations or requirements for importers/distributors)

There may be an exception if the distributor is making any changes such as translating the leaflet but this would be a bit of a grey area.

It is also worth noting that there is no requirement for a distributor to hold ISO 9001


The reason for my comment (despite parroting what has already been said) is because the proposed regulation that is due to come into force in 2019 does create new obligations for importers and distributors. There is some mention of a QMS although it isn't quite clear what this will be and whether 9001 will be harmonised for this purpose (13485 would still be inappropriate unless it was modified). That being said this regulation is still being debated by parliament and council and is subject to sigificnat change, therefore there is little point trying to comply with it just yet.
 
I

icarternz

#5
For info - for those exporting a bit further afield, the AHWP have drafted Guidance on adopting a QMS (13485) at Med Dev Distributors.
Take a look at the AHWP.info website - it was updated in Nov2014 (Its in the Documents-Guidance section).

The IMDRF hadn't come up with something similar, but this might be useful for a look over. I do recall seeing something similar for CMDR a while back.

Whilst 13485 is for manufacturers, the requirements are all about the life cycle of a product, which does include distribution.
 

somashekar

Staff member
Super Moderator
#6
For info - for those exporting a bit further afield, the AHWP have drafted Guidance on adopting a QMS (13485) at Med Dev Distributors.
Take a look at the AHWP.info website - it was updated in Nov2014 (Its in the Documents-Guidance section).

The IMDRF hadn't come up with something similar, but this might be useful for a look over. I do recall seeing something similar for CMDR a while back.

Whilst 13485 is for manufacturers, the requirements are all about the life cycle of a product, which does include distribution.
The ISO13485 title reads ...
Medical devices - QMS - Requirements for regulatory purposes.
1. Does the distributor has to respect any regulatory requirements in his business, that he can bring it into the QMS
2. Based on the devices he buys, stores and distributes, what have to be his Infrastructure and work environment requirements.
3. Any specific competency concerning the handling of the medical devices, Identification and traceability
4. Is he responsible to handle returned devices from customers. What precautions to avoid mix-up
5. Suitable risk management documentation concerning to his process (Consider risk to patient / user) and ISO14971 is not mandatory.
6. His role in feedback and advisory notices / recalls process.
7. Customer property
8. Systematic and logical reasoning for exclusions and non-applicability
.
..
...
and the rest becomes simple ISO9001.
 
Thread starter Similar threads Forum Replies Date
M Some possible misunderstandings on the application of ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 10
J Confused about application of ISO 13485 - Manufacturer of Medical Equipment & Device ISO 13485:2016 - Medical Device Quality Management Systems 14
somashekar Definition Exclusion vs. Non-Application - Definitions in ISO 13485 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 1
J ISO 13485 Clause 1.2 Application Clarification ISO 13485:2016 - Medical Device Quality Management Systems 1
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
C ISO 9001:2015 Monitoring and measuring resources. Application a service industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Sidney Vianna Informational ISO 18091 - Guidelines for the application of ISO 9001 in local government Other ISO and International Standards and European Regulations 1
C Application of ISO 9001:2015 Clause Interpretations for Service Industries Service Industry Specific Topics 2
Sidney Vianna Informational ISO/TS 9002 - Guidelines for the application of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
N Application of ISO 14971 to Medical Standalone Software ISO 13485:2016 - Medical Device Quality Management Systems 2
M FDA issues draft guidance to replace G95-1 (Application of ISO 10993) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Hershal PAC (Pacific Accreditation Cooperation) guidance on application of ISO/IEC 27000 IEC 27001 - Information Security Management Systems (ISMS) 0
L ISO 17021:2011 - The Application of Annex A - Work Instruction Details General Auditing Discussions 9
R ISO 9001 Clause 7.5.5 Preservation of Product - Application to Software Products ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
B ISO 9001 Application to my Business for the Production side of things only ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
somashekar ISO 9001 Clause 5.5.1 Responsibility and Authority - Application in various companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Application of Risk Management - ISO 14971 for a Tooling Manufacturer ISO 14971 - Medical Device Risk Management 18
Sidney Vianna ISO 22006 - Application of ISO 9001 in agriculture Food Safety - ISO 22000, HACCP (21 CFR 120) 2
C ISO 90003 - Guidelines for the application of ISO 9001 to computer software Software Quality Assurance 13
V ISO 14971:2007 Application of Risk Management to Medical Devices ISO 14971 - Medical Device Risk Management 9
M Market application of ISO PB70:2003? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D IWA2:2007 (guidelines for application of ISO in education) and good gap analysis tool Other ISO and International Standards and European Regulations 15
C Interpretation and Practical Application of ISO 17025 - Development of a System ISO 17025 related Discussions 81
T Application of ISO 14155 Clinical Trials Investigations EU Medical Device Regulations 5
M ISO/TS 16949:2002, clause 1.2:Application IATF 16949 - Automotive Quality Systems Standard 3
W Application of Risk Management - ISO 14971:2007(E) Medical Devices ISO 14971 - Medical Device Risk Management 69
Q ISO 9001 Clause 7.6 - Computer software to satisfy the intended application Records and Data - Quality, Legal and Other Evidence 8
J FMEA "Types" - ISO 14971 (Medical Devices - Application of Risk Management) ISO 14971 - Medical Device Risk Management 7
E My little web application about ISO 9000 - Looking for suggestions, comments etc. Software Quality Assurance 8
Q ISO 10993 - application to incidental skin contact of medical device Other ISO and International Standards and European Regulations 3
S ISO/IWA 2 - Guidance for the application of ISO 9001:2000 to educational services Service Industry Specific Topics 7
W Application for ISO 17025 Accreditation ISO 17025 related Discussions 1
E "Outsourcing processes" and ISO 9001 Clause 1.2 "Application" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Marc ISO/IEC 90003:2004 Software Engineering - Guidelines - Application of ISO 9001:2000 Other ISO and International Standards and European Regulations 6
U GMDN CODES application ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Monolithic application and medical devices ISO 13485:2016 - Medical Device Quality Management Systems 2
R CAMBODIA - Application of AMDD Other Medical Device Regulations World-Wide 2
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
C New Class III medical device application for Health Canada Canada Medical Device Regulations 6
T Commission proposal being drawn up for postponement for date of application of MDR (2017/745) EU Medical Device Regulations 7
N Program or application for standard time measurement in industry from video surveillance? Human Factors and Ergonomics in Engineering 1
J Are DAM tools, Mobile application, clinical dashboard, etc. considered accessories to medical device or supportive functions? Manufacturing and Related Processes 4
J Application of mains voltage on SIP/SOP connectors of medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
L External power supplies: How close does the safety report have to match the end-use application? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
P SOUP anomaly evaluation for MMA (Mobile Medical Application) IEC 62304 clause 7.1.3 IEC 62304 - Medical Device Software Life Cycle Processes 4
M Informational TGA presentation: How to submit an effective good manufacturing practice clearance application Medical Device and FDA Regulations and Standards News 0
Z Role of economic operators (EO) post the EU MDR Date of application in May 2020 EU Medical Device Regulations 1
P Scope of application for IEC 60601-1-11 Medical electrical equipment — Part 1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Informational EU – Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC Medical Device and FDA Regulations and Standards News 2
D FDA Biomarker Qualification Program - Has anyone prepared an application? Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom