Exporting to and Selling Devices in Spain

[michielus]

You don't need any repetition of the CE marking process, as you stated previously the label and IFU must be issued in Spanish
Unfortunately you need an extra registration as other countries like Italy, UK and Portugal for example
The type of registration depends on the classification of your device and also if you make the submission before or after the 21 March 2010

before 21 March 2010
If your products are class IIb and III you need to submit a "Comunicacion de puesta en el mercado" according art. 12 RD 414/1996 with fees / taxes of 400 Eur approx

after 21 March 2010
If your products are class IIa, IIb and III you need to submit a "Comunicacion de comercializacion y puesta en servicio" according art. 22 RD 1591/2009 with fees / taxes of 400 Eur approx

These communications require the presentation of the labeling, IFU, CE certificates and identification of the Spanish distributors

Dear Xavier,

I am not sure what your expertise in the medical device-area in Spain encompasses, but I hope you may be of help with the issue I am facing I have to find out if hospitals in Spain have any trouble accepting certified medical devices (MDD, class IIA), if these Medical Devices are available as a pharmaceutical product as well (think of an "active" which absorbs harmful substances in the intestines). I know for example that in France this is a big issue for the hospitals (i don't know why, maybe reimbursement or such).

Many thanks for helping me finding out!

 

[Ronen E]

...certified medical devices (MDD, class IIA), if these Medical Devices are available as a pharmaceutical product as well...

In the EC, an object is classified as either a medical device (could be a formulated device or a combination device; still, it is a medical device); a medicinal product (is this what you mean by "a pharmaceutical product"?); or none of the two. Once it is classified as a medical device, the Medicinal Product Directive doesn't normally apply, and vice versa. If it's certified as a medical device by a NB (class IIa) then such classification would be formalized - how would it be able then to be available on the EC as something that is not a medical device?

 

[michielus]

Hi Ronen,

I thought this would raise questions Please remember the Medical Device directive is not as old als the Medicinal/pharmaceutical legislation. Products that are actually a medical device, were registered as a medicinal/pharmaceutical product because there was no medical device legislation yet.

Authorities confirmed to me, by the way, that medicinal/pharmaceutical authorisations of products that nowadays meet medical device-criteria, will not be re-classified or banned from their medicinal/pharmaceutical status.

 

[Ronen E]

Thanks for the clarification.
If those devices were later cleared by a NB as class IIa medical devices (MDD), why do they need to continue to rely on the historical clearance as medicinal products?... If they are "also available as pharmaceuticals", I reckon someone places them on the market as such, don't they?...

 

[michielus]

yeah, our medical device product will enter a market with an identical medicinal product. So, we are trying to figure out how the Spanish hospitals would accept our product. You have any clues to this? Or do you know of consultants who are familiar with access to hospitals?

I'd appreciate any suggestions!

 

[michielus]

Dear everyone, I thought it would be good to summarize everything!

The history of the Medicinal products directive 2001/83/EC goes back much further than the Medical Device directive 93/42/EC. That means that products that today are regarded as a medical device, were regarded as a medicinal product when the Medical Device directive was not there yet. We are talking products registered before 1993

Some countries take new legislation as it is, some other countries appreciate what was first. I don?t know what Spain is like, but I was told they rather stick to what was first.

The point is, I am getting a product certified as medical device in Spain. A product with an identical indication of use and an identical main component is already registered as a medicinal product (since many years..). The main market will be emergency units in hospitals.

I need to find out how the emergency units would accept such a medical device-form of an old medicinal product. Who knows of an association or union of hospitals, a consultant or any other source of information that could help me out?

Many thanks!