MEDDEV 2.7/1 rev.4 published - June 2016

[Marcelo]

Finally published, MEDDEV 2.7/1 rev.4 - Clinical evaluation: Guide for manufacturers and notified bodies (2016) - http://ec.europa.eu/growth/sectors/medical-devices/guidance/index_en.htm

 

[Yasuaki]

Dear Marcelo,

Could you tell us what is the most different content from previous guide?

 

[Ronen E]

Dear Marcelo,

Could you tell us what is the most different content from previous guide?

http://www.qservegroup.com/blognieu...-2punt7punt1--rev-4.html#sthash.tuJXGjLC.dpbs

 

[Marcelo]

Thanks Ronen, I would suggest one of these overviews because I did not create my own yet.

Yasuaki, besides keeping the general evaluation process, the MEDDEV was fully revised, so there's a lot of "changes". Most are related to clarification or including more details on expectations (for example, the revised MEDDEV cites examples of systematic search and review methods such as PICO, where the old one only mentioned the need of systematic search and review methods).

 

[apuigvert]

Hello Marcelo,

Thanks for the link! We had the recertification audit few weeks ago and we are dealing with several NC that I consider are not quite fair.

One of them was regarding this MEDDEV and the post Marker surveillance process that we are carrying on. First of all, this guideline was apprved in June/206 and the Audit was in the same month, I know the MEDDEV are applicable immediatly, but is not possible to adapt an entire process in a few weeks.

The NC was regarding the Post Market review report, that was made based on the analysis of: FDA MAUDE, FDA recalls, internal complaints and internal CAPAs. The auditor says that the regulatory reports should be taken from all the Countries where the product is sold (adverse event reports, recalls, etc). This is quite difficult to implement, because if the company sells the product in an Asian Country (eg. Vietnam) we would need to understan vietnamese language to explore the regulatory authority webpage searching for Reports. This could happend with an European Country as well (Germany, France, Turkey...).

If I understood correctly, the MEDDEV requires the device to be compared with another CE marked device, this means that if any CE marked device had any problem, the Auth Rep and its NCA were notified, and the report should be on their database.

Anyway, my question would be. What is a good criteria for selecting the countries to collect regulatory data?

Thanks!

 

[Marcelo]

One of them was regarding this MEDDEV and the post Marker surveillance process that we are carrying on. First of all, this guideline was apprved in June/206 and the Audit was in the same month, I know the MEDDEV are applicable immediatly, but is not possible to adapt an entire process in a few weeks.

You got an NC due to not being in compliance with a MEDDEV? And the rev 4 in particular? Well, this does not make much sense. In practice, regarding the rev 4, some NBs are expecting that you have an implementation plan (which I think is reasonable).

The NC was regarding the Post Market review report, that was made based on the analysis of: FDA MAUDE, FDA recalls, internal complaints and internal CAPAs. The auditor says that the regulatory reports should be taken from all the Countries where the product is sold (adverse event reports, recalls, etc). This is quite difficult to implement, because if the company sells the product in an Asian Country (eg. Vietnam) we would need to understan vietnamese language to explore the regulatory authority webpage searching for Reports. This could happend with an European Country as well (Germany, France, Turkey...).

Well, I agree with the auditor, and that's what I do with my clients. You need to get market experience from your device from all markets, not only from the EU only. You have to feed back all of those inputs into your PMS and RM processes and verify if action need to be done. It's not acceptable to say that you won't get market experience of your device from a specific country it because it's in another language (why are you in the country in the first place, then?). Also, please note that this will be even more important in the new EU regulations due to the requirements of trending.

If I understood correctly, the MEDDEV requires the device to be compared with another CE marked device, this means that if any CE marked device had any problem, the Auth Rep and its NCA were notified, and the report should be on their database.

I'm not sure you understood your comment. So you mean the auditor is requiring that you get experience from the equivalent devices in all countries too in the PMS process? This is a bit of a stretch, I think.

Equivalency is more related to the premarket clinical evaluation, when you use an equivalent device data to verify yours if not enough data existis for your device. There's no specific requirements for your to gather market experience of an equivalent device AFAIK.

Theoretically, you would need to monitor experience of an equivalent device, but in this case I agree with you, due to resources, it's impossible to perform the same PMS process (all sources, reactive and proactive, etc.) for equivalent device as it's for your devices. So, historically manufacturers focus only on reported adverse events. But even in this case, it would be appropriate to verify equivalent adverse events in all countries too (as you are already required to do this for your devices, It's really not much of a burden to verify the same stuff for one or two additional equivalent devices too).

 

[apuigvert]

You got an NC due to not being in compliance with a MEDDEV? And the rev 4 in particular? Well, this does not make much sense. In practice, regarding the rev 4, some NBs are expecting that you have an implementation plan (which I think is reasonable).



Well, I agree with the auditor, and that's what I do with my clients. You need to get market experience from your device from all markets, not only from the EU only. You have to feed back all of those inputs into your PMS and RM processes and verify if action need to be done. It's not acceptable to say that you won't get market experience of your device from a specific country it because it's in another language (why are you in the country in the first place, then?). Also, please note that this will be even more important in the new EU regulations due to the requirements of trending.



I'm not sure you understood your comment. So you mean the auditor is requiring that you get experience from the equivalent devices in all countries too in the PMS process? This is a bit of a stretch, I think.

Equivalency is more related to the premarket clinical evaluation, when you use an equivalent device data to verify yours if not enough data existis for your device. There's no specific requirements for your to gather market experience of an equivalent device AFAIK.

Theoretically, you would need to monitor experience of an equivalent device, but in this case I agree with you, due to resources, it's impossible to perform the same PMS process (all sources, reactive and proactive, etc.) for equivalent device as it's for your devices. So, historically manufacturers focus only on reported adverse events. But even in this case, it would be appropriate to verify equivalent adverse events in all countries too (as you are already required to do this for your devices, It's really not much of a burden to verify the same stuff for one or two additional equivalent devices too).

Hello MArcelo! Thanks for your reply.

I've been thinking about how to implement the requirement to collect information from all the Countries. Is it acceptable to ask this information to the Distributors? but, if the Country doesn't have a developed regulation (eg many LATAM countires), or there is no database available?

This task seems to be a hard challenge and time consuming.

 

[Ronen E]

I don't think that there's an expectation to get 100% of the info or 100% of the adverse events or even cover 100% of the markets. You need to cover most of the markets, including all the major ones (in terms of your unit volume in each). If you sell one device here and another there, while 80-90% of the unit volume goes into a few identified markets, I don't think you'll be cited for not chasing all those sparse units.

The key is making a sincere and reasonable effort to collect the data. Distributors are a good channel to pursue, though they have their obvious limitations. At least they can help you close the language gap. Where there's no central, publicly open database and your distributors don't cooperate, I don't think it'll be held against you provided you have evidence that you seriously tried (eg contacted various distributors etc.).

Even where a perfect system exists, a lot of events don't even get reported properly. That should put things in perspective.

 

[Marcelo]

Ronen comment is on the spot, and it does apply to all PMS information.

But, more specifically, you do need to plan your PMS process/system how you get information on your device experience.

One of the possible sources is regulatory adverse event reports, and if a specific country does not have specific regulations and thus not have adverse event reporting, this can be a good justification for not having this information for that country. On the other hand, other sources of information should be planned.

If probably should review NB-MED/2.12/Rec1 Post-Marketing Surveillance (PMS) post market/production for examples of objectives and sources, and the new MEDDEV regulation proposal for a more general view of PMS.

I don't think you'll be cited for not chasing all those sparse units.

This is generally true, unless there's are real problems (for example, deaths) in that country In particular, you do not want to be notified by your NB or RAs from of serious incidents involving your device in other countries that you did not know (I've seen this happen with some clients in the past and it was devastating).

 

[Ronen E]

This is generally true, unless there's are real problems (for example, deaths) in that country In particular, you do not want to be notified by your NB or RAs from of serious incidents involving your device in other countries that you did not know (I've seen this happen with some clients in the past and it was devastating).

Yes, technically I agree. Mind you, it's not very likely that there will be a serious problem with a device that will only manifest in a random unit at an obscure market and not surface at all in at least one of that device's major markets. The exception will normally be language-related (labeling) or user-culture-related, which is why relationships with local distributors are most important in markets where formal adverse events reporting is lacking.