Retroactive application of harmonized standards

[yvettelloyd]

Does anyone have any information on retroactive application of newly promulgated harmonized standards? i.e., when a new harmonized standard is promulgated and there is an existing device deisgn that has already been approved to carry the CE Mark, does the manufacturer have an affirmative duty to retroactively apply the new harmonized standard to existing designs?

I have a "guidance" document on the New Approach format suggesting that such retroactive application is likely necessary. For example, if I had an device that was approved to carry the CE Mark in 1998, and the EMC testing was performed in accordance with the current standard at that time (1993), I understand that there is a reasonable expectation that the recent amendments to the EMC standard (2001) would have to be retroactively applied to the design and since there are new testing requirements, the device would have to go through re-test and possibly re-design if it did not meet the new requirements.

In essence, there is no "grandfathering" clause in the standards. I think that part of this stems from the "presumption of conformity" with the essential requirements as satisfied through compliance with the standards, as well as the belief that the new standards reflect the "state of art." This affirmative duty seems to be in direct contrast with FDA's thinking, as older device designs do not have to comply with a new standard unless the design changes.

I have discussed this with internal and external colleagues here, and there is a split of opinion. Most people have concurred with my opinion that a retroactive application is generally required, although there has been some strong dissenting opinions. Unfornately, the dissenters have not been able to find concrete evidence to support this contention. Does anyone know where to find information on this issue?

[Marc]

Any takers on this? Any help will be appreciated!

[Al Rosen]

Originally Posted by yvettelloyd

Does anyone have any information on retroactive application of newly promulgated harmonized standards? i.e., when a new harmonized standard is promulgated and there is an existing device deisgn that has already been approved to carry the CE Mark, does the manufacturer have an affirmative duty to retroactively apply the new harmonized standard to existing designs?

I have a "guidance" document on the New Approach format suggesting that such retroactive application is likely necessary. For example, if I had an device that was approved to carry the CE Mark in 1998, and the EMC testing was performed in accordance with the current standard at that time (1993), I understand that there is a reasonable expectation that the recent amendments to the EMC standard (2001) would have to be retroactively applied to the design and since there are new testing requirements, the device would have to go through re-test and possibly re-design if it did not meet the new requirements.

In essence, there is no "grandfathering" clause in the standards. I think that part of this stems from the "presumption of conformity" with the essential requirements as satisfied through compliance with the standards, as well as the belief that the new standards reflect the "state of art." This affirmative duty seems to be in direct contrast with FDA's thinking, as older device designs do not have to comply with a new standard unless the design changes.

I have discussed this with internal and external colleagues here, and there is a split of opinion. Most people have concurred with my opinion that a retroactive application is generally required, although there has been some strong dissenting opinions. Unfornately, the dissenters have not been able to find concrete evidence to support this contention. Does anyone know where to find information on this issue?

You are correct. The requirement is stated in essential requirements(#2) If dissenters are not satisfied, you could discuss it with your notified body to get a documented answer.