MDCG 2023-3 - is it me or was the rug just pulled?

[Errek]

Hi - long time lurker, felt the need to register and ask:
According to the newly released MDCG 2023-3 : "Some of the definitions presented in this document are reintroduced from the Guidelines on a Medical Devices Vigilance System with, where relevant, modifications for alignment with the MDR."
The "reintroduced" appears to reflect on the footnote: "Guidelines on a Medical Devices Vigilance System, MEDDEV 2/12-1 rev. 8, January 2013. Please note that the MEDDEV 2.12/1 rev. 8, January 2013 was in operation under the Directives (Directive 93/42/EEC concerning medical devices (MDD) and Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices (AIMDD)) and is not applicable under the MDR."

So. When following EU-MDR we were not supposed to follow Meddev 2.12-1 rev8, which is not only still currently published on the EU Docsroom, it even had an update side version in 2019. Am I the only one missing out on what exactly we should have followed, instead, before the February 2023 reporting of the MDCG 2023-3?

I feel like the rug was just pulled under me - it means I was using the reasons to normally not report, apparently against regulation. Am I alone in feeling this? Can someone tell me I'm wrong, and what I missed, should have done instead? Was any of you advised otherwise, and by whom? Notified body?

Thanks in advance for the advice.

 

[Ed Panek]

No, you are not the only one confused about which guidance documents to follow when it comes to medical device vigilance under the EU MDR. The transition to the new regulations has been complex, and there have been multiple guidance documents released over the years.

The MDCG 2023-3 document provides definitions for key terms related to medical device vigilance under the MDR, and notes that some of these definitions are based on the previous MEDDEV 2/12-1 rev. 8 guidance document. However, the document also notes that MEDDEV 2/12-1 rev. 8 was written for the previous Directives (MDD and AIMDD), and is not directly applicable to the MDR.

Instead, for guidance on medical device vigilance under the MDR, you should refer to the MDR itself, as well as other relevant guidance documents issued by the European Commission and the Medical Device Coordination Group (MDCG). Some examples of relevant guidance documents include MDCG 2020-3 on the summary of safety and clinical performance, MDCG 2020-6 on reporting of serious incidents, and MDCG 2020-8 on post-market surveillance.

In other news, the EU is set to vote on the MDR extension tomorrow


Transitional provisions for certain medical devices and in vitro diagnostic medical devices
Report:
[COM(2023)0010 - C9-0003/2023 - 2023/0005(COD)]
Committee on the Environment, Public Health and Food Safety


Agenda - Thursday, 16 February 2023 (europa.eu)

 

[Ronen E]

In other news, the EU is set to vote on the MDR extension tomorrow

I wouldn't dub it "MDR extension".
Anyone interested in an in-depth understanding of the meaning of this affair - it's explained in detail in Erik Vollebregt's blog.

 

[Errek]

Thank you for that feedback, good to know I am not alone. MDR being kicked down the road does not really matter to me at this point as I am dealing with products already registered under MDR.

So far I had not seen any movement on an MDCG filling the shoes of the Meddev 2.12-1 rev8. The pointers on what to do, in the MDR, are not as abundant as in that document, to say the least. And with that I mean mainly the "conditions where reporting under the medical device vigilance system is not usually required". These appear to have disappeared. This then means an uptick in reports to authorities. I have to wonder if those agencies are ready for that.

In fact, the more I read that MDCG, and also looking at the title -"Q&A on vigilance terms" versus "Guidelines on a medical devices vigilance system"- I have to wonder what the document's intention is. Perhaps more will come. Perhaps not.

You mentioned;

Some examples of relevant guidance documents include MDCG 2020-3 on the summary of safety and clinical performance, MDCG 2020-6 on reporting of serious incidents, and MDCG 2020-8 on post-market surveillance.]

... and thank you for that, but I cannot find an MDCG 2020-6 with that topic, rather that one points to clinical data for legacy devices.
Just to make sure I didn't miss something, is there any guidance out there for Serious Incident reporting as per Article 87?

Thanks again

 

[lamiareno]

The pointers on what to do, in the MDR, are not as abundant as in that document, to say the least. And with that I mean mainly the "conditions where reporting under the medical device vigilance system is not usually required". These appear to have disappeared. This then means an uptick in reports to authorities. I have to wonder if those agencies are ready for that.

So glad to come across this discussion. I'm wondering how other companies are dealing with that? While the risks are reduced to the acceptable level P1xP2 is always >0, this means reporting, even if the probability of harm is incredible. So far we were falling back on MEDDEV but this seems no longer to be an option. Any tips?

 

[Errek]

I'm afraid it is worse than that even: item 3 in that document:

"In a number of cases, the device may, due to its intended use, not directly(or instantly) lead to physical injury or damage to a person’s health but lead to indirect harm. Indirect harm may occur as a consequence of the medical decision, action taken or lack of such on the basis of information or result(s) provided by the device or as a consequence of a treatment. Indirect harm, due to an incident that meets or has the potential to meet the outcomes of a serious incident must be reported in accordance with Article 87(1) to (5) MDR."

So: service technician a day late, lack of action taken, as a consequence very minute lack of results from the device = reportalbe?
Reasonable answer is no. But how can I prove there is no indirect harm? Also, have I met auditors that were not reasonable? Unfortunately yes.

No reaction from any advisors yet, nor notified body. I suppose there will be a floodwave of reports coming to the Competent Authority agencies.
Are they ready? Because EUDAMED sure isn't...

 

[lamiareno]

I'm not sure how the situation you described should be handled but we are manufacturing class IIa software only and our products are linked exclusively with indirect benefits and risks (e.g. false negative software output - no action by the clinician - patient's deterioration), so that's something we already had to deal with.

But determination of reportability?

We can almost never exclude that a defect in our drug management software (with integrated databases for CDS) could not lead to S3/S4 (because of different types of drugs managed), but we could exclude them from reporting based on the remote probability. Now I don't know anymore. And it's not that we are trying to avoid our obligations, but I'm questioning the usefulness of considering bugs in our software in the categories of "what would happened if they re-occurred". Software defects are random, so this is more meaningful to evaluate on the level of trends as it says more about quality of the code/product.

 

[Errek]

We can almost never exclude that a defect in our drug management software (with integrated databases for CDS) could not lead to S3/S4 (because of different types of drugs managed), but we could exclude them from reporting based on the remote probability. Now I don't know anymore.

Exactly this.