Harmonised standards story?

Peter Selvey

Leader
Super Moderator
Obviously this is a wider question than just the 60601 series, but there might be someone watching this thread that might know the answer.

I've been out of the "main loop" of working with EU regulations since the MDR was introduced, so just working off publically available material from the Europa website.

Based on: Medical devices

the list of harmonised standards under the new MDR seems to be very short and does not even include EN 60601-1.

Some questions:

- is this the correct list, or am I missing something?
- is there a backstory to the lack of harmonised standards?
- is there an official or unofficial transition e.g. Notified bodies using the old MDD list for the time being?
- is there any formal documents e.g. MDCG addressing the issue

This is not for any particular case, I'm just interested to know the situation. Many thanks in advance.
 

Raisin picker

Quite Involved in Discussions
I heard (no source, sorry) that the MDD harmonized standards are to be used until they are replaced by MDR standards. An then, you always have to adhere to the state of the art, which would, what a coincidence, be covered by these standards ;-)
 

Peter Selvey

Leader
Super Moderator
I am wondering if the lawyers have had a closer look at the existing standards and ruled many of them as inappropriate to be referenced in law.

For example, IEC 60601 series often requires medical systems (e.g. patient monitor + sensor, device + PSU, device + accessories) to be tested together, even though that is incompatible with regulations, making a declaration of conformity, the basic definition of a type test especially when there are different manufacturers involved.

Another issue is the embedding of risk management in 601 itself (Clause 4.2), rather than having it co-exist. It's no problem for compliance with IEC 60601-1 to rely on solutions from risk management, but compliance with 601 should not itself be conditional on a compliant risk management system, since it creates a circular reference.

Plus, the particulars are riddled with technical errors, which is a natural result of the committee based writing, combined with an "all care/no responsibility" attitude of the IEC. With that structure, it's no surprise these standards have errors. Which might OK in the old system of throw the standard out there and wait for the errors to be handled on the ground, gradually reported and then fixed say over 10 years. But within the legal structure of the EU it might need a different system, e.g. a formal and practical validation of requirements and test methods, by a designated team independent of the writing team.

So, wondering if issues like this are creating a deadlock, with the IEC refusing to take any action while the EU refuses to recognise the standards?
 

Al_Z1

Involved In Discussions
So, wondering if issues like this are creating a deadlock, with the IEC refusing to take any action while the EU refuses to recognise the standards?
Something like this happened to ISO 14971:2019 while adpoting it to EN version. As I remember, first EN iteration was IDT, without typical annexes ZA etc., to harmonize it with MDR, and agreement process has taken more than a year.
 

Benjamin Weber

Trusted Information Resource
Hey Peter,

You are correct, the list is short. I had some insights during meetings of the german national (VDE/DKE). The main problem is not a technical but rather a juridical one. For example there are some differences between some defined terms in the standard and the MDR. So the HAS consultant rejected harmonisation. Actually the EU national committees voted to publish the latest 60601-1 as EN Version without the usual Z-annexes hence without harmonisation.

Currently there is a lot of work behind the scenes to solve this problem on more general level im order to make harmonisation possible within a more or less short period of time.

Currently the notified bodies are collecting first experiences with MDR certicifations and I am pretty sure there will some kind of (semi)official guidance on the application of standards for presumption of conformity.
 

Ronen E

Problem Solver
Moderator
Peter, let me throw in some info and experience, accumulated through working with the MDR and supporting published standards (including the 601 family), in the last few years.

As noted above, the current list of standards harmonized under the MDR is indeed short. I'm not closely involved in the politics around it (and there are plenty, as I hear), and not EU based, so no inside info here... However, it's officially documented that the lag in getting a proper harmonized standards list stemmed initially from some deep disagreements between the EU commission and CEN/CENELEC. This was not specific to 601, not at all; and it cost us in almost a year of delay. The initial harmonization "mandate" drafted by the commission got rejected by CEN/CENELEC, and it took about a year to draft a new one (that had better chances of being accepted) and then get it through the legal pipework to an approved status. This is M/575, which can now be relied on as reflecting the future full list of standards that will be harmonized under the MDR (not 100%, obviously, but some close figure - my guess).

The last list harmonized under MDD is a good starting point for SotA arguments, but it has no official or semi-official standing for MDR - AFAIK. Obviously, as time goes by it becomes less and less relevant as representing the SotA. It's mostly a last resort. I think that M/575 is a better reference, and it's also more current.

The latest from MDCG on harmonized standards, that I'm aware of, is MDCG 2021-5. But this is more of a general guidance on working with published standards in the MDR certification process, and as far as I remember it doesn't shed any more light on the delays/politics around the actual harmonized standards list.

The useful bit is the clarification of the expectation to establish/justify that a published version that is used is actually SotA; and that publication of a new version doesn't automatically push the SotA to align with that version (sometimes this is the crux of the debate - there is disagreement about some elements in a new version that "violate" or "exceed" the SotA, and might need to either "mature" into that status or be dialed back).

Any specific nuances or battles around 601 are unknown to me (not my expertise), but from knowing the big picture I can assure you that the delay / political war around MDR standards harmonization extends far beyond any technical disputes around 601. I'm not aware of "the EU system" having a specific issue with, for example, the particulars being flawed. I'm sure that the system is aware of the fact that they are, and would have preferred them fixed sooner rather than later, but I'm not aware of a sweeping change in approach, in that regard, from the good old MDD days... More likely everyone is happy to keep the status quo of "let's do our best in writing up standards, well knowing they are going to be initially flawed no matter what, gather experience in the certification process and in the field, and hopefully come up with a better version in the next 5-10 years... Hopefully not too many people will die in the process!..."

The adoption of standards as EN and reaching agreement on Z annexes are nothing but trivial, for an array or reasons that are not always accessible to us mortals.

Cheers,
Ronen
 
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cool1984

Involved In Discussions
Thank you to all the experts for your valuable information.
This is a rudimentary question, but I'm not sure about DoA.
For example, when is the DoA for EN ISO 14971: 2019 / A2021?
I understand it's ASAP, but is there any documentation that has clear DoA or deadlines?
 

Ronen E

Problem Solver
Moderator
Thank you to all the experts for your valuable information.
This is a rudimentary question, but I'm not sure about DoA.
For example, when is the DoA for EN ISO 14971: 2019 / A2021?
I understand it's ASAP, but is there any documentation that has clear DoA or deadlines?
Not sure what you mean by "DoA" in this context. Harmonization of the amendment?
 

cool1984

Involved In Discussions
Not sure what you mean by "DoA" in this context. Harmonization of the amendment?

I'm sorry to use confusing words.
The DoA I said means the date "By when do I have to comply with the standard?"

I understand EN ISO 14971: 2021, but some of our medical devices have the record of ISO14971: 2007 (before EN ISO 14971:2021), I am worried about when we need to update the records.
This is just an example, but I would like to know if the deadline for harmonized standards is clear under MDR, or if it is not clear and we should be addressed by ASAP.
 
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