Hi, Can somebody please tell if it is necessary to get certified to 13485 for Medical Devices?? Can you implement a QMS in accordance with 13485 and not go for certification, or for certain classes is it a requierment?? I am particularly interested in Class 1 with measuring function, class IIa and class III, but I would like to know how it works for all classes.
I have read through numerous threads and can't find a definitive answer...help! :bonk:

Hi, Can somebody please tell if it is necessary to get certified to 13485 for Medical Devices?? Can you implement a QMS in accordance with 13485 and not go for certification, or for certain classes is it a requierment?? I am particularly interested in Class 1 with measuring function, class IIa and class III, but I would like to know how it works for all classes.
I have read through numerous threads and can't find a definitive answer...help! :bonk:

Welcome Graham,

I'll let the experts answer your question but one detail that will help them is this: Where is your market (where do you export to) and do you need CE mark?

Markets are EU and ROW

The short answer is that you will need to have a third party assess your quality system. Read the MDD (http://elsmar.com/Forums/attachment.php?attachmentid=7823), Article 11 and determine the appropriate Annex. the annex that you apply will state whether you need a third party. I believe you will for all but annex VII.

Agreed.

The one-word answer for the regulatorily broad product activity you outline is "yes". And, to answer Harry's question for you, you will need the CE Mark.

If by "ROW" you mean to include the US, Canada and Japan, you'll have additional and substantial systematic requirements to meet for each of those countries as well.

Graham

ISO13485 is a harmonized standard for the EU MDD. This means that it is a 'golden standard' to comply with the quality requirements from the MDD. However it is not a requirement to have ISO13485 certification to get products CE marked! It makes live much easier, but... the minimum requirements for the quality system are listed in the Annexes of the MDD. It is the responsibility of the notified body auditor to ensure that these requirements are implemented.

Rob

Agreed.

The one-word answer for the regulatorily broad product activity you outline is "yes". And, to answer Harry's question for you, you will need the CE Mark.

If by "ROW" you mean to include the US, Canada and Japan, you'll have additional and substantial systematic requirements to meet for each of those countries as well.
If your intended market is Canada, then for you to acquire the licence, your certification to ISO 13485 by a recognized CMDCAS registrar is a requirement. So not only its a YES .. its also specific who certifies you in this case. Health Canada site has this info for you.

Graham

ISO13485 is a harmonized standard for the EU MDD. This means that it is a 'golden standard' to comply with the quality requirements from the MDD. However it is not a requirement to have ISO13485 certification to get products CE marked! It makes live much easier, but... the minimum requirements for the quality system are listed in the Annexes of the MDD. It is the responsibility of the notified body auditor to ensure that these requirements are implemented.

Rob

What Rob said. The way I like to explain it is that whilst it is not a requirement, we will be using ISO13485 as an audit tool, so you might as well end up with a certificate on your wall for the same level of effort.

Take it from me, if you are designing/making your own Class III device, you will need ISO13485. And no, it still would not be an absolute requirement under the MDD.

The only case where ISO13485 might arguably be dispensed with is where you are private-labelling someone's else's certified product. Even then there are still quality system elements you will need to establish (receiving/storage controls, labelling/overlabelling controls, traceability, vigilance/recall procedures, document/record retention procedures etc). If you are private-labelling a Class III device, the same applies, only moreso.

Hi All,

Thank you so much for your responses. So my understanding is that we must implement a QMS for the device classes mentioned, however certification to the standard is not a requirement, except for Canada, who specify that certfication is a requirement. However, when you have gone to all the trouble of implementing the QMS it makes good sence to get the cert (I agree!)
If for some reason you decided not to get it certified, how do the notified body handle the pre-approval inspection, what do they audit against? Is it just the MDD and the companys procedures??

Thanks again!:thanx:

Hi All,

Thank you so much for your responses. So my understanding is that we must implement a QMS for the device classes mentioned, however certification to the standard is not a requirement, except for Canada, who specify that certfication is a requirement. However, when you have gone to all the trouble of implementing the QMS it makes good sence to get the cert (I agree!)
If for some reason you decided not to get it certified, how do the notified body handle the pre-approval inspection, what do they audit against? Is it just the MDD and the companys procedures??

Thanks again!:thanx:

Yes, but the Notified Body will likely be using ISO13485 as an audit tool for any relevant QMS areas.


If for example you went for Annex VII + Annex VI for a Class IM measuring spoon, you would need to meet:

a) the regulatory procedure requirements of the MDD
b) the quality system requirements for incoming/final inspection of the spoon
c) the technical documentation (file) requirements for the spoon.


So as long as your regulatory stuff was in place, and you had basic and effective procedures for inspection, you could probably get by without certifying to ISO13485. It's not a move I would really recommend however.

Hi All,

Thank you so much for your responses. So my understanding is that we must implement a QMS for the device classes mentioned, however certification to the standard is not a requirement, except for Canada, who specify that certfication is a requirement. However, when you have gone to all the trouble of implementing the QMS it makes good sence to get the cert (I agree!)
If for some reason you decided not to get it certified, how do the notified body handle the pre-approval inspection, what do they audit against? Is it just the MDD and the companys procedures??

Thanks again!:thanx:You need an asessment by a third party for anything above class 1. If you had taken my advice in my previous post and read the MDD, it would have been evident to you. Since ISO 13485 is a harmonized standard for the MDD, (http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html) registration to it makes it easier to show compliance. You would find this out after you speak to a Notified Body (http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13&type_dir=NO%20CPD&pro_id=99999&prc_id=99999&ann_id=99999&prc_anx=99999), which you will also need. I always recommend finding a Notified Body as your first step (http://www.devicelink.com/mddi/archive/08/10/007.html). Just my :2cents:.

Also in Japan, ISO 13485:2003 (translated in JIS Q 13485:2005) is mandatory for most Class II, III and IV medical device manufacturers (with additional requirements imposed under Japanese law).

Nowadags, if you have CE-marked products without ISO13485 certification, you have less chance becoming a "qualied" supplier to a distributor or end user in EU.

I spend much of my time doing international submissions, and I have to say that the most requested document is the ISO 13485 certificate. It is the gold standard. As others have said, the CE mark and ISO 13485 go hand in hand, and these are essential in getting non-US/EU approvals.

Regards,
Shawn

The International Standard ISO 13485:2003 provides a fundamental baseline for compliance with the European CE marking Medical Devices Directives, Japan Pharmaceutical Affairs Law (PAL) and Health Canada CMDCAS requirements. Also emphasis in IS0 13485:2003 on meeting customer and regulatory requirements as against increasing customer satisfaction and also considered to be fully compatible with the FDA QSR. So my advice is first start implementing the quality management system and gets certified with ISO 13485.

Thanks and Regards
S. Subramaniam