Application of ISO 13485 to a Medical Device distributor

[Colin]

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?

 

[MIREGMGR]

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]

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]

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.

 

[icarternz]

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]

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.