Clarifying the many different Medical Device national and international standards

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mr.mike

Hi Everyone,
First let me say, I REALLY appreciate the great help and advice I've got on these forums.... but being new to MD regulatory affairs, I realize I'm probably getting ahead of myself.

So to backtrack a bit, can someone out there offer guidance (or link to a good introductory document) for an unexperienced person such as myself as to the different standards, and how they interrelate?

Specifically, given that we'd like to keep our potential markets as large as possible, what are the documents that are critical to the MD industry?

From my own scouting about, I've come up with the following short-list (if you can correct/append/comment that'd be great!):

International: IEC 60601-1 (& its collateral and applicable vertical standards)
European-Union: MDD 93/42/EEC
United-States: FDA CFR 21
Australia: ARGMD (Australian Regulatory Guidelines for Medical Devices)
Canada: Health Canada SOR/98-282

Also, a continuing source of confusion for me is with the different bodies/groups issuing standards, how they differ, and where they apply.
Specifically, can someone clarify what's the difference between ISO, IEC, EN and UL?

Apologies for the randomness of this post, but it seems like I'm doing a lot of reading without a clear picture of what's-what. :eek:
Any guidance to get me a handle on all these different bodies/regions/standards etc. would be much appreciated!

As always, thank you kindly!
MM.
 

Marcelo

Inactive Registered Visitor
Re: Clarifying the many different Medical Device standards

Standards are created by SDOs (standard developing organizations), and of the ones you mentioned, only IEC is a SDO. ISO and IEC are international SDOs, meaning, they are not related to any country and they product consensus international standards).

The other entities you mention are regulatory bodies, which create laws or regulations.

The main link is, standards are voluntary, regulations are mandatory. Regulations usually permit the use of voluntary standards to show conformance with some criteria.

EN = european standard, a standard created by CEN or CENELEC (european SDOs).

UL = Ul is a lot of things, and they also create some standards.

For a good general reading, i would suggest Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety
G.R Higson

A.though this book is focused in the european regulations and standards, it does give a very good overview of everything related to regulations and standards for medical devices.

You could also take a look at different GHTF documents, such as Role of Standards in the Assessment of Medical Devices and others from http :/ / www. ghtf. org /sg1/sg1-final.html DEAD - 404 - LINK UNLINKED
 
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mr.mike

Re: Clarifying the many different Medical Device standards

Thanks Marcelo for your prompt reply.

So, just to summarize:
UL, EN: regulatory bodies, mandatory (given applicable region)
ISO, IEC: standard developing organizations (SDOs), voluntary (but often used as evidence for compliance to the mandatory regulations)

Seems to make sense. But looking over some of our company records (before my time), I'm still a bit confused. Awhile back, we had some tests done on a device for which the following certificates were issued (I'm quoting from the certificates themselves):

1) CU US+Canada NRTL-Certificate
Standard(s): UL 60601-1:2003 R4.06; CAN/CSA-C22.2 No. 60601-1-08

2) T License (USA/Asia)
Standard(s): EN 60601-1:2006

3) CB-Certification
Standard(s): IEC 60601-1:2005

Can you clarify for me what these mean?
Here's my take/questions (please correct me if I'm wrong):

1) The UL 60601-1 compliance is required for FDA & Health Canada approval?

2) The T-License: is the (USA/Asia) reference a misprint? given that the EN standard is European?

3) The CB-Certification helps demonstrate compliance to MDD 93/42/EEC essential requirements, and hence is useful in obtaining EU CE marking.

Are these assements correct? (I believe, at the time, the company just left it up to the test-labs to decide what was required...but now that I've been appointed, I'd like to actually know myself!).
 

Marcelo

Inactive Registered Visitor
UL is not a regulatory body, it´s more of a certification body and test house, but it is also some other things in the US. EN is not a regulatory body, it´s a denomination for european standards (European Norm).

For medical devices, the regulatory body in the US is FDA. In Europe, it´s the European Comission (and each country has it´s Competent Authorities (CAs), which is somewhat like the FDA in the US).

1) The UL 60601-1 compliance is required for FDA & Health Canada approval?

Not required but it´s easier if you are compliant (also, in US you "might" need some compliance for OSHA or something- please take a look at the following thread for more info: Do I need to have UL or TUV or other mark to sell device in USA)

2) The T-License: is the (USA/Asia) reference a misprint? given that the EN standard is European?

Not sure, maybe TUV mark. As it´s an EN standard, it problably is used for CE marking.

3) The CB-Certification helps demonstrate compliance to MDD 93/42/EEC essential requirements, and hence is useful in obtaining EU CE marking.

The CB - hopefully CB-Scheme - is a worldwide scheme, you can use this for some regulations.

Are these assements correct? (I believe, at the time, the company just left it up to the test-labs to decide what was required...but now that I've been appointed, I'd like to actually know myself!).

This is usually the case, the manufacturer let the tes house and test labs do the work and when you try to figure out, it´s this mess (just a general remark, it does happen a lot). It´s great that you are trying to figure it out, because doing swo gives you more power regarding how to conduct the best regulatory strategy for your products (and although a lot of people talk about regulatory strategy, there´s in fact bery few that implement it correctly :)).
 
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mr.mike

Thanks once again. In particular, for the link to the other thread. It contained a bunch of clarifying advice.

Also, this is an older thread, but a lot of good background for those out there like me!
http://elsmar.com/Forums/showthread.php?t=7148

Finally, it's nice to know that I'm not alone in inheriting a strategy previously on autopilot! :)
 
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