EU MDD Requirement on impact of Rev STDs and audit non-conformance

B

BILLH007

#1
Qestion is on the EU MDD requirements and audit non-conformance.

For CE Mark Assessment on a medical device client received a non-conformance
because standards referenced in product spec and technical file docs were
not checked for updates to standards referenced and files were not assessed for update impacts.

Non-conformance was "Assessment of new/revised standards impact on
existing devices needs to be part of Company's process. The review should
be documented and action plans developed."

Applicable Standard Cited: Continued Compliance to MDD Annex 1: Ref Annex I, II

First, does observation make sense to you.
2nd, Does anyone have a checklist, process or flowchart that depicts or guides
the needed review?

Alternately How do you (posting respondents) assure most current standard revision like electronics (IEC 60601-?-? ) called out is updated in technical file and file checked for impacts?

Thanks BILLH007
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Re: EU MDD Requirement on impact of Rev STDs

Alternately How do you (posting respondents) assure most current standard revision like electronics (IEC 60601-?-? ) called out is updated in technical file and file checked for impacts?
We keep track via management effort. We hear about revised standards here, from other informal notification means, from our NB, from our Authorized Rep, and in some cases from standards organizations. When a revision or update process is underway, we create a project to review and update our compliance stance in a timely manner, generally involving Engineering and Regulatory, plus perhaps Marketing and sometimes Sales.
 

Michael Malis

Quite Involved in Discussions
#3
Qestion is on the EU MDD requirements and audit non-conformance.

For CE Mark Assessment on a medical device client received a non-conformance
because standards referenced in product spec and technical file docs were
not checked for updates to standards referenced and files were not assessed for update impacts.

Non-conformance was "Assessment of new/revised standards impact on
existing devices needs to be part of Company's process. The review should
be documented and action plans developed."

Applicable Standard Cited: Continued Compliance to MDD Annex 1: Ref Annex I, II

First, does observation make sense to you.
2nd, Does anyone have a checklist, process or flowchart that depicts or guides
the needed review?

Alternately How do you (posting respondents) assure most current standard revision like electronics (IEC 60601-?-? ) called out is updated in technical file and file checked for impacts?

Thanks BILLH007
First, observation make sense.
In addition to the above, we also getting updates from our participation with Standards Committees and subscription to e-service...
Second, you also need to identify "the gaps" from most current standard to old revision. This will allow you to address what is required in TF. Don't forget a Risk Assessment for TF while doing this.
 

Peter Selvey

Staff member
Super Moderator
#4
Just to confirm it is a valid non-conformance. The way the MDD works is that if you don't apply a current harmonised standard (even to older designs) you need to provide explanation of alternate solutions. To do this you still need to know what is in the harmonised standard even if you don't want to comply with it, and then document the alternate solution.

But keep in mind this is only for harmonised standards, which means you only need to keep an eye on Europa website for updates. Transition periods of 2-3 years also give plenty of warning. Keeping an eye out for new IEC or ISO documents can give up to 3-5 years warning.
 
B

BILLH007

#5
Thanks Peter,

So if technical file has no risk plan/report as per ISO 14971 now needs added. Or IEC 60601-1-? required safety etc the documentation needs added to technical file prior to superceded date.

Did I get that right?

Bill Hufford
 

Peter Selvey

Staff member
Super Moderator
#6
For ISO 14971:2000, definitely yes since it has been harmonised since April 2004 (replacing EN 1441 on that date). So, nearly 6 years ago, and a high profile standard as well.

Little known fact about risk, though - the MDD specifically states that:

Whereas the essential requirements and other requirements set out in the Annexes to this Directive, including any reference to [FONT=TimesNewRoman+20][FONT=TimesNewRoman+20][/FONT][/FONT]minimizing[FONT=TimesNewRoman+20][FONT=TimesNewRoman+20][/FONT][/FONT]or [FONT=TimesNewRoman+20][FONT=TimesNewRoman+20][/FONT][/FONT]reducing[FONT=TimesNewRoman+20][FONT=TimesNewRoman+20][/FONT][/FONT]risk must be interpreted and applied in such a way as to take account of technology and practice existing at the time of design and of technical and economical considerations compatible with a high level of protection of health and safety;

and


"..the essential requirements should be applied with discretion to take account of the technological level existing at the time of design and of technical and economic considerations compatible with a high level of protection of health and safety"


Both of these statements give you some scope to relax on updating older equipment, but the phrase "... compatible with a high level of protection..." means you still need to keep an eye on things for serious risks.​

As suggested before you should be aware of the content of new standards are and make a decision on what to apply, keep a record of these decisions. In practice this usually means a report (checklist) showing each clause sequentially, and linking to supporting evidence if needed.​
 

Michael Malis

Quite Involved in Discussions
#7
For ISO 14971:2000, definitely yes since it has been harmonised since April 2004 (replacing EN 1441 on that date). So, nearly 6 years ago, and a high profile standard as well.

Little known fact about risk, though - the MDD specifically states that:

Whereas the essential requirements and other requirements set out in the Annexes to this Directive, including any reference to [FONT=TimesNewRoman+20][FONT=TimesNewRoman+20][/FONT][/FONT]minimizing[FONT=TimesNewRoman+20][FONT=TimesNewRoman+20][/FONT][/FONT]or [FONT=TimesNewRoman+20][FONT=TimesNewRoman+20][/FONT][/FONT]reducing[FONT=TimesNewRoman+20][FONT=TimesNewRoman+20][/FONT][/FONT]risk must be interpreted and applied in such a way as to take account of technology and practice existing at the time of design and of technical and economical considerations compatible with a high level of protection of health and safety;

and


"..the essential requirements should be applied with discretion to take account of the technological level existing at the time of design and of technical and economic considerations compatible with a high level of protection of health and safety"


Both of these statements give you some scope to relax on updating older equipment, but the phrase "... compatible with a high level of protection..." means you still need to keep an eye on things for serious risks.​

As suggested before you should be aware of the content of new standards are and make a decision on what to apply, keep a record of these decisions. In practice this usually means a report (checklist) showing each clause sequentially, and linking to supporting evidence if needed.​
14971 latest revision is 2007. So if you plan to do something from scratch, you may as well to comply to the latest standard...
 
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