Keeping up with "State-of-the-Art" & updated Standards

Mark Meer

Trusted Information Resource
#1
I'm presently challenged by a legacy product that was commercialized years ago, and the design (and design docs, DHF) have not changed since. But since the time of development, several standards have been updated (e.g. 60601-1, -1-2), and there have also been other harmonized standards added to the list.

My question is: in order to demonstrate "state-of-the-art", must we continually test to new standards?
I realise the standards are (in theory) voluntary, and perhaps justification can be made to not re-test to the latest standards (as well as any new harmonized standards)...but has anyone actually done this with NB approval? If so, what approach did you use to justify not complying with newest standards, and still be able to claim state-of-the-art?

If the general approach adopted by most manufacturers is to simply ensure that products are always tested to modern standards, I'm baulking at the potential logistics here. Suppose you have 20 products. When a major revision to a standard (e.g. 60601-1 2nd to 3rd edition), is the expectation that all products be retested? The cost would be incredible!

Anyway, just curious what approaches other have with respect to continually updated standards..
Any input much appreciated!
MM
 
Elsmar Forum Sponsor

Remus

Involved In Discussions
#2
You can compare old and new standard, and only perform missing tests. But you have to perfrom new standard tests. Sadly, CE marking is very expensive these days.
 

Mark Meer

Trusted Information Resource
#3
Sadly, CE marking is very expensive these days.
Sigh. I thought as much... :(

It may also be the case for other design files? If, for example, EN 62366 (Usability Engineering), or EN 62366 (Software Life-Cycle Processes) gets updated, I presume previous documentation will have to be updated, along with the cascade of associated verification/validation activities, in order to meet most recent standards' requirements?

Like I say, with all the standards that change (and new ones added), the resources necessary to ensure all CE products are always updated is a resourcing nightmare!

----
Related question:
Suppose the legacy product was tested to 60601-1 2nd edition, and has been on the market for years. We now test to the most recent edition (3.1), and the product is found to not meet all the requirements of the new edition. What implication does this have for all the devices already sold? Technically, they are all now non-compliant, no?
 

Ronen E

Problem Solver
Staff member
Moderator
#4
I second Remus.

Related question:
Suppose the legacy product was tested to 60601-1 2nd edition, and has been on the market for years. We now test to the most recent edition (3.1), and the product is found to not meet all the requirements of the new edition. What implication does this have for all the devices already sold? Technically, they are all now non-compliant, no?
No. The requirement to keep up with the state of the art is applicable to placing units on the market. Once units have been put into use, you switch from "premarket" to "postmarket" set of requirements / expectations.
 

Pads38

Trusted Information Resource
#5
60601-1 Ed2 - Ed3

All the main electrical requirements are the same (leakage currents; creep and clear; earth currents). So if you have a Ed 2 tested device it is most likely to be OK for Ed 3.

-1-2 (EMC)

Up to the 2007 (Ed3) version it should be possible to do a 'delta' set of tests. ie some frequency ranges were extended and additional tests added.

But the 2015 (Ed 4) version is quite different and will probably require a complete re-test. The ESD tests are significantly more onerous and I foresee many difficulties.

62366 (Usability)
The latests version (2015) has an Annex C detailing a process to be used for 'legacy' devices. This has proved very useful - using real world post-marketing information you can create a report to satisfy these requirements easily and quickly.

62304 (Software life cycle)
Amendment 1 (2015) similarly introduced requirements for legacy devices. I have yet to use this so am not yet familiar with it.
 

jon.loo

Starting to get Involved
#6
I second Remus.



No. The requirement to keep up with the state of the art is applicable to placing units on the market. Once units have been put into use, you switch from "premarket" to "postmarket" set of requirements / expectations.
Are you able to share more on how the "premarket" and "postmarket" expectations differs in with regards to this? Where can I find more information regarding the difference in requirements/expectations between pre- and post- market?
 

Mark Meer

Trusted Information Resource
#7
Are you able to share more on how the "premarket" and "postmarket" expectations differs in with regards to this?
Pre-market is essentially before devices are distributed on the market. So the process of CE marking, which is described in the regulations. This will (except in the case of Class I) involve assessment by a Notified Body, who will confirm conformance to the regulation's essential requirements, and often (voluntarily) involves demonstrating compliance to any applicable harmonized standards.

Post-market is after devices are out there on the market. This would be your surveillance and vigilance activities. For example, you need to have a system in place for handling complaints, recalls, and reporting adverse events. The MEDDEV Guidance documents provide some guidance. In particular, MEDDEV 2.12/1 rev.8, provides guidance on medical devices vigilance system.

MM.
 

jon.loo

Starting to get Involved
#8
But won't the requirements to meet the essential principles still be consistent from pre- to post- market? In this sense wont the need to conform to principles considered to be state of the art still be required for those in "post-market" phase?
 

Mark Meer

Trusted Information Resource
#9
But won't the requirements to meet the essential principles still be consistent from pre- to post- market? In this sense wont the need to conform to principles considered to be state of the art still be required for those in "post-market" phase?
The regulations use the language "...shall be designed and manufactured...".
So:
  • If the device is in a design phase, state-of-the-art applies.
  • If the device is being manufactured, state-of-the-art applies.
  • If a given unit of the device is in the field (has already been distributed), state-of-the-art does not apply - the assumption being that it was state-of-the-art at the time it was designed and manufactured.
 

pkost

Trusted Information Resource
#10
Regarding post market obligations, you should consider that the product at time of release is "safe and effective". An update to a standard does not make it less safe or effective.

If authorities expected recalls whenever a standard was updated and an existing product could no longer comply it would send costs skyrocketing and in all likelihood result in continual out of stocks for critical products.
 
Thread starter Similar threads Forum Replies Date
U Manufacturing solutions and keeping records on quality Content CE Marking (Conformité Européene) / CB Scheme 3
Sidney Vianna Are the Accreditation Bodies doing their job? Keeping CB's accountable Registrars and Notified Bodies 0
A Alternative to keeping hard copy records that is 21 CFR part 11 compliant Document Control Systems, Procedures, Forms and Templates 0
S Employee Training Matrix - Keeping track of employee training on various SOPs ISO 13485:2016 - Medical Device Quality Management Systems 4
S Keeping track of the changing Medical Device Standards Other Medical Device Related Standards 3
S Corporate Quality Manager keeping me out of the Management Review Meeting Management Review Meetings and related Processes 28
S Is not keeping inspection record an ISO 9001 nonconformity? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
K Keeping the test samples in after market nlight alloy wheel production Manufacturing and Related Processes 2
A What is the definition of Installation that requires Record Keeping vs Set-up 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
C Implementing ISO 3834-2 - Keeping the organization informed Other ISO and International Standards and European Regulations 3
L Keeping current on new/revised MEDDEVs EU Medical Device Regulations 8
S Requirements for keeping Records in Electronic Format Records and Data - Quality, Legal and Other Evidence 15
D Keeping Same Medical Device Name but Changing Classification Medical Information Technology, Medical Software and Health Informatics 3
M Keeping Packaging Material and Photographs in Sync with Inventory Manufacturing and Related Processes 5
R FDA Rules and Requirements for Keeping Ink Signed Documents 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
M Quality Procedures - General Detail Level and Record Keeping Requirements Document Control Systems, Procedures, Forms and Templates 6
J Annual PPAPs - Keeping Up with Hundreds Of Customers And Hundreds Of Part Numbers APQP and PPAP 12
I Keeping up with changes to External Standards Document Control Systems, Procedures, Forms and Templates 8
T Keeping Track of Procedure Implementation Training Activities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Keeping Milk for Domestic Consumption Fresh - - Ideas? Coffee Break and Water Cooler Discussions 33
C Keeping Employees Updated on Newly Revised Procedures Document Control Systems, Procedures, Forms and Templates 15
A Document Relationship Matrix - Keeping Track of References to Related Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Wes Bucey Keeping your cool means keeping your job Career and Occupation Discussions 12
M Employee Turnover vs. Keeping up with Training Training - Internal, External, Online and Distance Learning 7
L 5S Auditing & Accountibility - Keeping our 5S tool boards complete and accounted for Lean in Manufacturing and Service Industries 13
J Keeping Gage R&R Samples Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
arios Keeping Records of Competence of Employees Records and Data - Quality, Legal and Other Evidence 4
S Keeping Employee Self-Motivation Strong Human Factors and Ergonomics in Engineering 23
ScottK 15 year record keeping requirement? Components for Medical Devices Records and Data - Quality, Legal and Other Evidence 16
Casana Keeping old ISO certificates of registration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S Keeping up with all those changes! Document Control Systems, Procedures, Forms and Templates 5
B Keeping an External Auditor on because he's "useless"... ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 55
Marc Paying Attention and Keeping Eyes Open - Girl Falls into Floor Funny Stuff - Jokes and Humour 4
R Keeping the Passion of an ISO9001 System - How to promote your QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
H Keeping Control of Controlled Documents Document Control Systems, Procedures, Forms and Templates 21
C Keeping ISO TS 16949 Certification During Forced Production Interruption IATF 16949 - Automotive Quality Systems Standard 2
B Keeping your Windows PC running Smoothly After Work and Weekend Discussion Topics 18
A Keeping prototype devices - Is there a regulatory or compendial requirement? ISO 13485:2016 - Medical Device Quality Management Systems 3
Wes Bucey Keeping the job and angling for promotion Career and Occupation Discussions 7
H Keeping a Stable Process for a company, any suggestions? Should I being doing more? Quality Tools, Improvement and Analysis 5
K Struggling with keeping part-time internal auditors in our program Internal Auditing 15
T Occurance of Non-Conformance, MRB (Material Review Board) and Record keeping Records and Data - Quality, Legal and Other Evidence 34
Marc Contract Firms Keeping Training Records Records and Data - Quality, Legal and Other Evidence 2
E Record Retention - NC for keeping records longer than our defined minimum Records and Data - Quality, Legal and Other Evidence 9
G Keeping Horses in the City Coffee Break and Water Cooler Discussions 13
apestate Keeping Procedures Simple - 15 person machine shop using text procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Starting Fresh or Keeping your QS procedures? IATF 16949 - Automotive Quality Systems Standard 3
R ISO 14001 - Determining and Keeping Current with Legal Requirements ISO 14001:2015 Specific Discussions 10
D Mixed Product - Keeping one product from being mixed with similar product Misc. Quality Assurance and Business Systems Related Topics 12
B Audit Teams - We have trouble keeping auditors General Auditing Discussions 11

Similar threads

Top Bottom