Is ISO 13485 certification necessary for Class I (non-sterile) medical devices?

[Jana Mani]

Hi.

We are manufacturer for Class I(non-sterile) medical devices. We also certified under EN ISO 13485 and ISO 9001 for non-sterile medical devices as our majority market demand is from EU. Our products include non-sterile urine bag. As these are self-declared devices, right now we are considering to just have ISO 9001 and drop EN ISO 13485. Is this advisable or it is better to have both certification.

Kindly advise on this.

 

[DutchMarten]

As it is a medical device you are producing I would say an iso 13485 is certainly a valuable certification to have. But so long as you comply with the MDR it is not a necessity to have an ISO 13485 certification, as it is a standard, unless so required by your clients. Do you only manufacture medical devices or also other products? If you only make medical devices you could consider dropping ISO 9001 as ISO 13485 is basically a more applied and specific version of ISO 9001 for medical device manufacturers.

Again it is a choice and also dependant on what you hear in terms of demands from the market.

 

[IVDRegs01]

Annex I of the MDR detail the General Safety and Performance Requirements that you have to meet as a Medical Device manufacturer, regardless of the classification of that medical device. Compliance with harmonised standards (including ISO 13485) makes compliance with the GSPRs much easier to prove, however if you have ISO 9001 certification and other systems and procedures in place to cover the rest of the GSPRs, and are able to evidence this adequately in an audit, you should be ok. As the comment above states, it's your choice and may depend on what your customers want...

 

[Ed Panek]

Outside of legal requirements, I can tell you that a valid current 13485 Cert goes a long way into vetting a supplier for us.

 

[chris1price]

As others have said, certification to ISO13485 is desirable but not a regulatory requirement. If you go down the ISO9001-only route, make sure you still meet the requirements laid out in Article 10 of the MDR.

 

[TheRealLobster]

Can you also use a Registrar - rather than a Notified Body - for your QMS certificate (13485) if you're Class A non-sterile?

 

[LUFAN]

Can you also use a Registrar - rather than a Notified Body - for your QMS certificate (13485) if you're Class A non-sterile?

There's kind of a comingling of terms here. Just to clarify:
Registrar's issue ISO 13485 certifications
Notified Bodies issue CE Certificates
Audit Organizations issue MDSAP certificates.
In other words, BSI, can be all three in different contexts.

In order to obtain a CE certificate and issue a CE Mark, you need a notified body. The notified body needs proof that you have a QMS in place. Most manufacturers will have their notified body perform their QMS audits (as a Registrar) and issue their ISO cert to avoid a duplicate audit, however, it is very possible for someone else to issue that QMS cert, and your notified body to essentially repeat some/most of those audit activities for their own confirmation without issuing an additional certificate.

Long way of saying, yes, a third party registrar can issue a QMS certificate, however, the economics of which may not make sense.

 

[Jana Mani]

Thank you all!!!