EN46002 vs. ISO 13485 - Transition Route

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Bill Marshall

I've just been talking to a registrar about the transition options available to us and wanted to check out if his approach is different to other people's experience.

We have CE marking via Annex 7 supported by 9002:94 and 46002:96.

He suggested that 9002:94 is not necessary to support CE marking so long as we maintain the 46002 QA system and meet the specific requirements of the Medical Devices Directive. So we could allow the 9002 to lapse.

In parallel with this we should develop systems that comply with 13485:2003 which he says should be complete by July this year. We could then register to this at our next annual visit in the Summer of next year.

This seems like quite a light approach and takes the pressure off our transition programme this year, and gives us until next Summer to move across to the new approach.

Is this a common interpretation ? I'd welcome any feedback about the transition route other people are taking.



Bill Marshall
 
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Aaron Lupo

Bill-

EN46002 was replaced by ISO 13485, the last I heard about the transition period for 13485:2003 was that you needed to be compliant with it by 12/15/03. In addition, you do not need to be EN or ISO anything to maintain a CE mark. If you look at the MDD it states, you need to have a quality system but does not say that it must be ISO or EN compliant. Just out of curiosity who is your notified body?
 
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Bill Marshall

I think that 46002 has been superced by 13485 by not replaced, nor withdraw. In fact the BSI website says "Current".

The notified body is AMTAC and the bloke I spoke to said that there would be a one transition from 46002:97, and a three year transition from 13485:2001.

He then gave two options :-

Stay with 46002 until 1 year after the new 13485 is published,

Or, we could transfer to 13485:96 now, then we would have 3 years after the new 13485 is published.

The second option gives the longer transition time, but I don't really want to encourage the managment team to go any slower on this than necessary.


regards

Bill Marshall
 
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Aaron Lupo

Bill Marshall said:

I think that 46002 has been superced by 13485 by not replaced, nor withdraw. In fact the BSI website says "Current".

The notified body is AMTAC and the bloke I spoke to said that there would be a one transition from 46002:97, and a three year transition from 13485:2001.

He then gave two options :-

Stay with 46002 until 1 year after the new 13485 is published,

Or, we could transfer to 13485:96 now, then we would have 3 years after the new 13485 is published.

The second option gives the longer transition time, but I don't really want to encourage the managment team to go any slower on this than necessary.


regards

Bill Marshall

Superseded=replace last time I looked.

ISO 13485 was last published in 1996 not 2001 and the revision is currently in
Stage 50.20

FDIS ballot initiated:
2 months.
Proof sent to secretariat.

EN46002 was last published in 1996 not 1997.

As far as having 3 years to upgrade I will have to double check on that, last I knew they were saying you had until 12/15/03 to upgrade.


In any event obtaining 13485:2003 certification should not be very hard to complete. We are currently in the process of upgrading and the amount of work required is minimal.
 
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Bill Marshall

I get my documents from BSI and the dates I have quoted reflect this. I appreciate that ISO publishing dates are sometimes earlier.


46002 has not yet been "replaced" as the harmonised standard, which is why it's still used and recognised.

It does seem strange that there are different deadlines for the two standards that the new 13485 will replace, that's partly what inspired the question in the first place.

Although I expect the transition will be straightforward, the timing of our annual visit makes it important that we chose the right path now to minimise the effort over the next 12 months. There's no point in doing two transitions, when only one is necessary.
 
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Aaron Lupo

Bill it is my understanding that EN 13485/88 replaces EN 46001/2. I have seen this stated on numerous websites, however, you have to go by what your Notified Body tells you.

Just an FYI, I was informed that the release of 13485:2003 has now been pushed back until mid to late 2003 from the anticipated dated of 1st quarter 2003. In addition ISO/TC 210/WG 1 is preparing guidance on the transition period (which will more than likely be 3 years now) which will be made publicly available.
 
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45fan

Regarding harmonized standards, when in doubt about dates and such, I go to the Official Journal of the EU (https://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html).

Exerpt re MDD QA system is:

CEN EN ISO 13485/8[:1986...became EN on] 2002-07-31 [OJ publication C182]
Reference of the superseded standard: EN 46001/2
Date of cessation of presumption of conformity of the superseded standard: 2004-03-01 (Note 1)

Note 1: Generally the date of cessation of presumption of conformity will be the date of withdrawal ( "dow"), set by the European Standardisation Organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise.

Let me see if I have it right...

EN 46001/2 are in effect until March 1, 04. We can choose to use EN ISO 13485 NOW, if we like, but its not mandatory. When the 2003 rev becomes an EN is anybody's guess, so using the standards to demonstrate conformity for CE mark likely won't change for a while.

So if we're just concerned about our ISO certificate, we will also have until early 2006 to comply with 13485:2003 because of the three-year transition period.

I don't see any reason to rush the transition, unless you have the time and resources.
 
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