Is Harmonised EN 1041 (Information Supplied By Manufacturer) Worth Looking At?

[Mark Meer]

Anyone know if EN 1041:2008 (Information supplied by the manufacturer of medical devices) is worth purchasing, and taking a look at?

It's a harmonised standard, but IMO the requirements for information to be supplied is already pretty clear in the Directive.

Anyone familiar with the standard found it valuable / worth looking into?

 

[indubioush]

You should follow this standard if you plan on selling product in Europe. With that said, it is up to you whether to take the risk of not purchasing the standard. There is some information in there that is not found in the MDR, but it is fairly minor, and this standard is mean to supplement the directive, not the MDR. (I assume that when you said directive you meant medical device regulation.)

 

[Mark Meer]

...There is some information in there that is not found in the MDR, but it is fairly minor...

What I'm curious about is whether this information is valuable.
Like I say, IMO, the "Requirements Regarding Information Supplied with The Device" of Chapter III of Annex I of the MDR are already pretty clear, and straight forward to demonstrate conformity to.

In short, my question is this: has anyone found using this standard helpful in demonstrating conformity to MDR requirements?

 

[Ronen E]

Until an MDR harmonized standards list is issued, no standards are harmonized under the MDR. EN 1041 is only harmonized under the MDD.

 

[Mark Meer]

Until an MDR harmonized standards list is issued, no standards are harmonized under the MDR. EN 1041 is only harmonized under the MDD.

Yes, but with the May 2020 transition deadline fast approaching, presumably organizations are still making use of the standards listed for MDD (insofar as they could be applied to MDR requirements), to evidence conformity to MDR... otherwise what else is there? Unless I'm missing some other strategy, this seems the best approach given no other (straightforward) options, no?

In anycase, I'll reframe the question: has anyone found using EN 1041 helpful in demonstrating conformity to MDD requirements?

 

[Ronen E]

Yes, but with the May 2020 transition deadline fast approaching, presumably organizations are still making use of the standards listed for MDD (insofar as they could be applied to MDR requirements), to evidence conformity to MDR... otherwise what else is there? Unless I'm missing some other strategy, this seems the best approach given no other (straightforward) options, no?

I didn't say you shouldn't be applying published standards in support of your effort to comply (and show that compliance) with the MDR. I only highlighted the fact that at the moment no standard can provide the "sought-after" presumption of conformity under the MDR. The MDD harmonized standards list makes a reasonable source of standards that may be beneficial in that regard (mind you, it was last updated >2 years ago!...) but it has no legal significance for MDR compliance, unfortunately.

It's been said here that NBs "expect" manufacturers to apply the relevant standards harmonized under the MDD, during MDR audits, but I don't know what this exactly means and how / how strictly NBs are applying such policy (if it in fact exists). Also all NBs are NOT the same.

 

[indubioush]

has anyone found using EN 1041 helpful in demonstrating conformity to MDD requirements?

Yes, this standard is helpful in demonstrating conformity to MDD requirements. This standard lists wording from the MDD and clarifies it. But do you want to comply with the MDD? No, you want to comply with the MDR. Your safe bet here is to review this standard, and apply all requirements that do not conflict and go above and beyond MDR requirements.

To provide further info, this standard does not have much content when you cut out the MDD clarifications. It has requirements for date formats and a few other things.

 

[twanmul]

I've found the IVD specific version of this standard (ISO18113) useful for our IVD products and would suggest you use it. I agree with above, you should be using this as part of your assessment of the device against the GSPR's under the MDR now rather than ER's under the MDD.