This is a somewhat general question regarding the different requirements of the European Medical Device Directive and an ISO 13485 based QMS used to demonstrate conformity to the essential principals of the MDD.

The MDD, unless I am mistaken, is primarily concerned with ensuring that medical devices are safe and all effort has been made to remove/minimize risks to patients or end-users. Fair enough, I say.

ISO 13485 treats safety as one (important) aspect of overall quality. Fair enough too.

However, I should be able to say that the way we do Process X leaves a lot to be desired from a quality perspective but in no way effects the safety of the Device (from risk analysis), and hence we still meet the Essential Requirements of the MDD.

However, if I said that, the QMS would not pass (re)certification, and my Medical Device would not be saleable.

Wouldn't it be appropriate for a Standard based on a subset of ISO 13485 and involved purely with saftey to be used to demonstrate MDD conformity?

An overworked Quality Engineer
Simon

First of all, 13485 is not a requirement per se. A quality system is required.

Second, if I read you correctly then crappy quality shouldn't be considered an issue if I don't die or get injured...:mg:

Seriously, I do appreciate your frustrations, but I don't think that the trail of thought is productive. :bigwave:

Perhaps, just perhaps, it is time for you to move on to a manufacturer who actually wants to produce and market quality items. They do exist, or so I have been told :lol:

Hi Gert,

I am not actually arguing that quality is unimportant, just that it should be, or at least can be, separate from demonstrating compliance with the MDD.

Yes, 13485 is not a requirement ... but name me another?

thanks for the comments
Simon

Second, if I read you correctly then crappy quality shouldn't be considered an issue if I don't die or get injured...:mg:


And actually, you are right, crappy quality shouldn't be considered an issue when it comes to being ALLOWED to sell a product into a market, even a medical market. The market place will make its own decision about what level of quality it demands. Isn't this what a free market would do?

Simon

Yes, 13485 is not a requirement ... but name me another?

thanks for the comments
Simon

In the MDD there is no requirement for a specific system, however there is a requirement for you to have a system in place and have it evaluated by a NB. Depending on the route that you choose for your CE-mark you can have a lot of variations of this.

And actually, you are right, crappy quality shouldn't be considered an issue when it comes to being ALLOWED to sell a product into a market, even a medical market. The market place will make its own decision about what level of quality it demands. Isn't this what a free market would do?

Simon

I really like your trail of thought :notme: Let's apply that to all aspects of our society: Brakes for cars, controlsystems for trains, supplies for airlines, the food we eat, etc. etc. Some times there is a reason for legislation, and sometimes that reason is consumer safety. IMO that's quite OK.

In the MDD there is no requirement for a specific system, however there is a requirement for you to have a system in place and have it evaluated by a NB. Depending on the route that you choose for your CE-mark you can have a lot of variations of this.

I realise there are other avenues to certification. But what other quality systems apart from 13485 are recognised? Having a non-standard quality system certified is cost prohibitive.


I really like your trail of thought :notme: Let's apply that to all aspects of our society: Brakes for cars, controlsystems for trains, supplies for airlines, the food we eat, etc. etc. Some times there is a reason for legislation, and sometimes that reason is consumer safety. IMO that's quite OK.

You have misinterpreted what I am trying to say. Safety is important and should be regulated - we are in agreement.

Let me try again:
The quality system, by definition, is interested in all aspects of quality.
All work instructions or procedures that effect quality are controlled by the quality system, but it does not mean they all effect safety.

If I have non-conformities in my quality system which DO NOT effect safety, my ability to sell a device into a market should not be effected by regulation.

my two bits worth
Simon

I realise there are other avenues to certification. But what other quality systems apart from 13485 are recognised? Having a non-standard quality system certified is cost prohibitive.



You have misinterpreted what I am trying to say. Safety is important and should be regulated - we are in agreement.

Let me try again:
The quality system, by definition, is interested in all aspects of quality.
All work instructions or procedures that effect quality are controlled by the quality system, but it does not mean they all effect safety.

If I have non-conformities in my quality system which DO NOT effect safety, my ability to sell a device into a market should not be effected by regulation.

my two bits worth
Simon
Unfortunately that's not how the directive is written. BTW, what is an example?

s.parakos,

You do not need a quality system at all.

You can choose to follow Annex III (Type Examination (for Class IIb and III)) and Annex IV (EC Verification (of every single product, or statistical testing of large batches)).

Or you follow Annex II or V or VI and establish a quality management system (full, production quality or product quality).

But if you have chosen a path, you have to follow ist, until you decide to change the path.

And it depends on the issue, if a non-conformity is sufficient to revoke a certificate.

This is a somewhat general question regarding the different requirements of the European Medical Device Directive and an ISO 13485 based QMS used to demonstrate conformity to the essential principals of the MDD.

The MDD, unless I am mistaken, is primarily concerned with ensuring that medical devices are safe and all effort has been made to remove/minimize risks to patients or end-users. Fair enough, I say.

You are indeed mistaken. The MDD is about international trade. Safe and effective medical devices are by-products of that.


ISO 13485 treats safety as one (important) aspect of overall quality. Fair enough too.

I could be wrong, but I don't think the word 'safety' is actually mentioned at all within ISO13485.

However, I should be able to say that the way we do Process X leaves a lot to be desired from a quality perspective but in no way effects the safety of the Device (from risk analysis), and hence we still meet the Essential Requirements of the MDD.

I hear that argument a lot. It is usually shot down in flames. :notme:

The thing is pretty much any element of a company's quality system eventually impacts whether a "quality" device will get shipped.


However, if I said that, the QMS would not pass (re)certification, and my Medical Device would not be saleable.

Indeed. :)

When this happens my next task is to explain why this is not me being "picky", "unfair", "stealing bread from my children's mouths" etc etc. :cool:

But you seem to have an example in mind - try us.... :)


Wouldn't it be appropriate for a Standard based on a subset of ISO 13485 and involved purely with safety to be used to demonstrate MDD conformity?.


There are many (probably hundreds) of standards associated with product safety. Some even make reference to ISO13485.

But ISO13485 isn't about product safety. It is about establishing an all-encompassing system that provides an environment in which product safety is a beneficial by-product.

An overworked Quality Engineer
Simon

Why are you over-worked? If it is due to under-resourcing, that is a possibly quality systems failure. But (assuming so), your being under-resourced doesn't have an immediate direct impact on product safety, so I should be able to raise a special kind of NC that still lets that product into my market....?

I don't think so...:cool:

I could be wrong, but I don't think the word 'safety' is actually mentioned at all within ISO13485. It is mentioned.

Reading my post, it may come across a bit snarky, that wasn't my intent!

I think we would all be interested in learning about the background to your query, many of us have seen/heard this kind of thing before and thus may be able to assist.