MDD, MDR/IVDR, Working Groups, Expert Panels, MEDDEVs and Other EU Guidances

Ronen E

Problem Solver
Staff member
Moderator
#21
But New Zealand, maybe too small and not interested enough to appoint someone. But maybe willing to, if I'm annoying enough. ;)
I don't know NZ too well, but if Australia is an indication for that (and it is for many things), then it's probably too cliquey for you to be able to get in, no matter how competent you are and how honest your intentions. I don't think size has much relevance, it's a culture thing. And, if you think you can annoy them to a breaking point, think British culture... endless politeness and intricate protocols never fail :)
They might not care about citizenship, or equally likely, they have stopped thinking about it by the time they got down to the level of working groups.
Hmmm... if it's in the protocol then you can be quite sure it will be pursued, and the heck with common sense.
 
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Watchcat

Trusted Information Resource
#22
it's probably too cliquey for you to be able to get in
Now you're thinking like Erik. I don't want to get into anything except Rev 5. If they are planning to appoint someone from their clique, then they will. But if the clique is too small or no one in it is interested in Rev 5, then who knows, maybe, but probably not. The industry doesn't like clinical, so clinical types are not on every street corner. Or in every clique.

Hmmm... if it's in the protocol then you can be quite sure it will be pursued, and the heck with common sense.
Not counting on common sense, but on bureaucracy.
 

Ronen E

Problem Solver
Staff member
Moderator
#23
I don't want to get into anything except Rev 5.
I don't think it works that way. That's what I meant when I wrote "the heck with common sense". You can be a world-class expert on something, but if you don't fit the opening that exists on the books (typically "a Member" of something), then it's just too bad. And they won't change the books for you either.

Years ago I had the unfortunate experience of my assistance denied by the Australian national committee contributing to an ISO technical standard that dealt exactly with something I've worked on for years. The only way they would have accepted my contribution was as a committee member, but at the time I didn't qualify due to an administrative technicality. And that was the end of it. Kiwis are sometimes slightly more flexible than Aussies, but I wouldn't count on it.
But if the clique is too small or no one in it is interested in Rev 5, then who knows
Nah.
Cliques are designed to keep outsiders on the outside, regardless of circumstances. Otherwise they wouldn't be cliques, would they?...
The only way to infiltrate a clique is by having an ally on the inside, but how to get one is a skill I haven't cracked yet :)
 

Marcelo

Inactive Registered Visitor
#24
Nah.
Cliques are designed to keep outsiders on the outside, regardless of circumstances. Otherwise they wouldn't be cliques, would they?...
The only way to infiltrate a clique is by having an ally on the inside, but how to get one is a skill I haven't cracked yet :)
I don't think there are "cliques" or anything sinister in these things, because usually the rules are very clear (if you don't agree with them, it's another matter).

Also, having an ally does not help all the time.

The main problem here is that we have at least two situations:

- Individual participation in government affairs (including things like standardization, which may not be government per se)

- Group participation in government affairs

The first case is the one with expert panels on the EU. Any individual that meet the defined requirements can offer itself and be appointed (and in this case an "ally" may help)

The second case is the MDCG sub-groups. These are interested parties/class/group representations, so even if you fulfill the requirements for an individual, if you are not member of the specific group and appointed by the specific group, you can't be there. These groups (in the case of medical devices) usually represent industry (such as associations of manufacturers), doctors (such as society of anesthesiologists or other) and patients (such as patient specific groups ).
 

Watchcat

Trusted Information Resource
#26
Cliques are designed to keep outsiders on the outside,
That's because inside and outside is what defines a clique. The true mission of any organization is the organization itself.
To the extent that this applies here, then it means the clique doesn't care about Rev 5, nor who participates in it, because Rev 5 has nothing to do with the clique.

The only way they would have accepted my contribution was as a committee member
Understood. But NZ doesn't have to accept my contribution.

The only way to infiltrate a clique
Not something I'm ever inclined to want to do.
I don't think there are "cliques" or anything sinister in these things, because usually the rules are very clear (if you don't agree with them, it's another matter).

Also, having an ally does not help all the time.

The main problem here is that we have at least two situations:

- Individual participation in government affairs (including things like standardization, which may not be government per se)

- Group participation in government affairs

The first case is the one with expert panels on the EU. Any individual that meet the defined requirements can offer itself and be appointed (and in this case an "ally" may help)

The second case is the MDCG sub-groups. These are interested parties/class/group representations, so even if you fulfill the requirements for an individual, if you are not member of the specific group and appointed by the specific group, you can't be there. These groups (in the case of medical devices) usually represent industry (such as associations of manufacturers), doctors (such as society of anesthesiologists or other) and patients (such as patient specific groups ).
 

Watchcat

Trusted Information Resource
#27
I don't think there are "cliques" or anything sinister in these things, because usually the rules are very clear
Cliques are pretty much always in "these things." Who do you think writes the rules? Cliques will happen unless someone actively works to prevent them. Most people don't know that this will happen, and often don't care if it does, or know how to prevent it from happening, even if they wanted to. Cliques form, first and foremost, due to apathy towards the stated mission, despite all the rhetoric to the contrary. And so eventually the clique itself becomes the mission. Often the clique doesn't realize this and thinks that its efforts to maintain itself are efforts to achieve the stated mission.

I've noticed that this process has accelerated, apparently with the rise of data mining as a profitable enterprise. We have reached a point where often no one even pretends to have an interest in the mission, just in finding a mission that attracts other people to sign up, preferably those who care only just enough to sign up, but no more than that, so the organization doesn't have to deal with any further expectations. Partisan politics are exactly like this, too.
 

Ronen E

Problem Solver
Staff member
Moderator
#28
I don't think there are "cliques" or anything sinister in these things, because usually the rules are very clear (if you don't agree with them, it's another matter).

Also, having an ally does not help all the time.

The main problem here is that we have at least two situations:

- Individual participation in government affairs (including things like standardization, which may not be government per se)

- Group participation in government affairs

The first case is the one with expert panels on the EU. Any individual that meet the defined requirements can offer itself and be appointed (and in this case an "ally" may help)

The second case is the MDCG sub-groups. These are interested parties/class/group representations, so even if you fulfill the requirements for an individual, if you are not member of the specific group and appointed by the specific group, you can't be there. These groups (in the case of medical devices) usually represent industry (such as associations of manufacturers), doctors (such as society of anesthesiologists or other) and patients (such as patient specific groups ).
Marcelo, I'm sure you're not doing it intentionally, but you're playing into the hands of those interested in making it all look very "clean", "technical" (or just procedural), fair, transparent etc. But some parts of some systems are rigged to be impenetrable from the outside. For example, sometimes a powerful org "representing manufacturers" makes it practically impossible to join (and thus impossible to contribute as an individual; does not belonging to a big org mean your experience is necessarily worthless?). You may say "these are the rules" and you are right in that, but the rules are not necessarily based on common sense or the greater good of the public. Ask yourself, who makes the rules?... There are lots of ulterior motives in these affairs. Not sinister maybe, but definitely not pure either.

My comments were not directed specifically at the EU system - I don't know its insides well enough. I made them in the context of AU/NZ, after Watchcat highlighted NZ as a potential path for participation, and from my own personal perspective based on my experience in Australia and outside it. Perhaps in your home country it works differently. I know at least one other country where it's definitely different, which goes to show it doesn't have to be this way.
 

Ronen E

Problem Solver
Staff member
Moderator
#29
Most people don't know that this will happen, and often don't care if it does, or know how to prevent it from happening, even if they wanted to. Cliques form, first and foremost, due to apathy towards the stated mission, despite all the rhetoric to the contrary. And so eventually the clique itself becomes the mission. Often the clique doesn't realize this and thinks that its efforts to maintain itself are efforts to achieve the stated mission.
:yes: This reflects my experience down here.
The sentence I highlighted is exactly what I encountered - they truly believed they were "defending" something, from me apparently... heh.
 

Marcelo

Inactive Registered Visitor
#30
Marcelo, I'm sure you're not doing it intentionally, but you're playing into the hands of those interested in making it all look very "clean", "technical" (or just procedural), fair, transparent etc. But some parts of some systems are rigged to be impenetrable from the outside. For example, sometimes a powerful org "representing manufacturers" makes it practically impossible to join (and thus impossible to contribute as an individual; does not belonging to a big org mean your experience is necessarily worthless?). You may say "these are the rules" and you are right in that, but the rules are not necessarily based on common sense or the greater good of the public. Ask yourself, who makes the rules?... There are lots of ulterior motives in these affairs. Not sinister maybe, but definitely not pure either.
.
I'm not playing into the hands of anyone, in particular, because I do participate in theses things (for some decades now) and I know more or less how they work. It's a mix of society and business. This has been how historically society has been evolving, together with the business world.

For example, you say: " sometimes a powerful org "representing manufacturers" makes it practically impossible to join (and thus impossible to contribute as an individual; does not belonging to a big org mean your experience is necessarily worthless?).".

As I mentioned, there's different kinds of involvement. Usually individuals can participate in public consultations (open to anyone), but before that, when government creates these public consultations, they do not make them open to individuals, they usually make them open to groups representing interested parties. This is very common and a very reasonable approach (if you would draft a document with anyone, you would never get anything). So yes, this is simply common sense. Now, only because in the draft step you cannot participate as an an individual (and this would go into what you say - (and thus impossible to contribute as an individual; does not belonging to a big org mean your experience is necessarily worthless? - in this case, worthless is not the term, but unqualified or something is) this does not mean that the system is rigged. But the comments here seem to imply that there's a sinister scheme that closes these doors to any big company or companies that have money.

Unfortunately, although it's obvious that money play games and may get some advantages (for example, it's easier for a big corporation to spend money on travel and participation in several different places, which one person or small organization would not do), this is not the reality that I've seen participating in some of these discussions for some time.

I do understand the realities are different from country to country, but generally, these management practices are a basis for any work, government or not.
 
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