Implementation period for standards - CE renewal submission - Class II medical device

[murena]

I am currently working on a CE renewal submission for a Class II medical device, and I have reviewed the documentation that was submitted 4 years ago. There have been some standards that have been upgraded on the past years, so I want to know what is the typical period for a standard version to be phased out and the new version to become the only recognized.

I have consulted the list of harmonised standards in the EC webpage, but not all the standards that we used are in there (some ASTMs, MILs, etc), so I just want to have some kind of rule of thumb to assess if an old version is still valid or if I need to retest or develop a justification for not retesting, in case the new version is the only one valid.

I remember a 3 years transition period was mentioned somewhere, but I have not been able to find it anywhere. Obviously, I want to minimize the need for retesting, as this product has been in the market for 4 years without problems, and repeating the verification just because a standard was updated does not really add much value.

What do you think?

Thanks.

 

[harry]

Re: Implementation period for standards - CE renewal submission - Class II medical de

so I want to know what is the typical period for a standard version to be phased out and the new version to become the only recognized.

This is just my 2 cents. Most standards that I know of do not have a pre-set or indicative period for revision/updating purpose. Infact, the original proponents would had prefer it to remain in perpetuity if possible. However, when there is a danger for it to become irrelevant, it's time for an update. In other words, they need revision in response to changes in the business or technology environment.

One example is accounting standards. If you follow the British practice, you will note that accounting and/or reporting standards are always reactive in nature - changed after a major scandal in the business world. The latest major change was after Enron. The foreseeable change coming will be after the current 'Satyam' case in India.

Another standard that I am familiar is BS 8110 for design of concrete structures. It had evolved over time due to advancement in the field of concrete technology, steel technology and requirements such as fire resistance and many others. Infact, BS 8110 is being withdrawn in UK, replaced by a certain EuroCode. All these in response to changes in the technology and needs environment.

 

[Al Rosen]

Re: Implementation period for standards - CE renewal submission - Class II medical de

You may be interested in this discussion.

 

[jkuil]

Re: Implementation period for standards - CE renewal submission - Class II medical de

For Europe you can identify the DOCOPOCOSS at http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html


DOCOPOCOSS
(DOCOPOCOSS = Date of cessation of presumption of conformity of superseded standard, but I presumed you understood that abbreviation )

The European Commission decides which ENs can give 'presumption of conformity' with a Directive. It does this by 'notifying' the standard in the 'Official Journal of the European Community' (OJEC). This can be viewed on the Web without charge.
When it notifies a standard, it also says when it comes into effect, by giving the date beyond which the application of any previous standard becomes unacceptable. This date is the 'date of cessation of presumption of conformity of the superseded standard' - the 'docopocoss'.
After this date, the manufacturer must not ship any products conforming only to the old standard, but distributors (and retailers) have about a year to dispose of stocks.