Pharma Company wants to become Medical Device Manufacturer

pkost

Trusted Information Resource
#1
Sorry for the vagueness of this question (I'm from a device background and know nothing of the pharma side)....

If an EU pharmaceutical company were to move into the world of devices, what changes would they need to make from a quality and regulatory perspective? I see that there is a directive (2003/94/EC) which relates to GMP in europe but my quick skim through seemed to suggest that it wasn't a complete QMS like 13485.
 
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Ajit Basrur

Staff member
Admin
#2
Sorry for the vagueness of this question (I'm from a device background and know nothing of the pharma side)....

If an EU pharmaceutical company were to move into the world of devices, what changes would they need to make from a quality and regulatory perspective? I see that there is a directive (2003/94/EC) which relates to GMP in europe but my quick skim through seemed to suggest that it wasn't a complete QMS like 13485.
Would it be manufacture of medical device components or a finished medical device ?
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Sorry for the vagueness of this question (I'm from a device background and know nothing of the pharma side)....

If an EU pharmaceutical company were to move into the world of devices, what changes would they need to make from a quality and regulatory perspective? I see that there is a directive (2003/94/EC) which relates to GMP in europe but my quick skim through seemed to suggest that it wasn't a complete QMS like 13485.
Hi,

The answer would depend on:
1) Where they currently sell.
2) What sort of products they currently make ("pharmaceutical company" is a very broad term).
3) What regulatory / technical standards (including all EC directives and regulations) they are currently in compliance with (especially, but not only, certified compliance).
4) What sort of devices they intend to make, and where they intend to sell them.

Please send me a PM if you are interested in a thorough review and unable to share the details in public. I also come from a devices background, but I also have some pharma QA/regulatory experience.

Cheers,
Ronen.
 

pkost

Trusted Information Resource
#4
thanks for your responses, I will try to answer your questions as best I can...

They will be a manufacturer and place their own CE mark on the product.

ronen:
1. they currently sell in europe
2. Yes it is broad isn't it!
3. I'm afraid I don't know
4. They will make Class I's and II's (a and b) to be sold in europe


Again - sorry for the vague answers!
 

c.mitch

Quite Involved in Discussions
#5
I try a vague answer to your vague question :)

Have a look at the 93/42 EEC directive, modified by 2007/47 directive. There is a short explanation here :http://europa.eu/legislation_summar..._goods/technical_harmonisation/l21010b_en.htm
It contains also links a consolidated version of the directive and links to IVD and active implantable devices, covered by other directives.

By the way, one way to be in conformity with it is to have a full ISO 13485 QMS.

Regards,

Mitch.
 

pkost

Trusted Information Resource
#6
Hi C.mitch

Thanks for your vague answer ;)

I'm aware of the device side of things, and the end point the company should be aiming for...I just don't know what the starting point is...i.e. what sort of quality system would a pharma company have.

a better way for me to have phrased the question would have been....How does the quality system of an EU pharmaceutical company differ from that of an EU medical device company which holds 13485 certification.
 
S

SteveK

#7
Hi C.mitch

Thanks for your vague answer ;)

I'm aware of the device side of things, and the end point the company should be aiming for...I just don't know what the starting point is...i.e. what sort of quality system would a pharma company have.

a better way for me to have phrased the question would have been....How does the quality system of an EU pharmaceutical company differ from that of an EU medical device company which holds 13485 certification.
I used to work for a large EU Pharmaceutical company - supplied worldwide and were FDA audited (previous life ago!). They used to supply drug delivery devices - so not medical devices as such under the MDD. However they did also supply some related products that were truely (Class I) medical devices - I know I registered them with the then MDA. Everything on the quality side was covered by GMP (and cGMP). There was no seeming requirement for ISO 13485 (or BS EN 46001 as was) or ISO 9001. I believe things are still the same in the pharma industry (I am going back 10 years though).:2cents:

Steve
 
P

phloQS

#9
Hi pkost,

I will try another vague answer. I have some experience with pharmaceutical companies which need an ISO 13485, because they want to sell medical devices. In general they have their site master file and their SOPs which fit in about 90% to Iso13485. There are some special needs e.g. Quality policy or Managementreview which have to be included. I built a comparison matrix for the auditor who accepted the " new site master file" and the Sops as the Q-Manual. So it was kind of "integrated management system". I want to point out that this is a way to install a QMS for regulatory compliance. This is not a very effectiv QMS.

Regards

phloQS
 

Ronen E

Problem Solver
Staff member
Moderator
#10
If an EU pharmaceutical company were to move into the world of devices, what changes would they need to make from a quality and regulatory perspective? I see that there is a directive (2003/94/EC) which relates to GMP in europe but my quick skim through seemed to suggest that it wasn't a complete QMS like 13485.
thanks for your responses, I will try to answer your questions as best I can...

They will be a manufacturer and place their own CE mark on the product.

ronen:
1. they currently sell in europe
2. Yes it is broad isn't it!
3. I'm afraid I don't know
4. They will make Class I's and II's (a and b) to be sold in europe


Again - sorry for the vague answers!
Hi,

If they currently sell in Europe (and I assume they do it legally) then they should probably already be in compliance with the GMP directive you've mentioned, as well as with the medicinal product directive. This is a good starting point, which means they only need to bridge the gap to full ISO 13485 (class IIb medical devices - they may want to implement the MDD Annex II), and the gap shouldn't be too big. Seems like a detailed gap analysis would be the right thing to start with.

Other than that it seems they will have to go through the usual MDD compliance course, for their newly introduced medical devices.

Cheers,
Ronen.
 
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