Spain Class I Medical Device Registration

M

MD_Simy86

Dear all,
I'm looking for a clarification regarding medical device registration in Spain.

I know that in Spain, as a member state of the European Union, medical devices are regulated according to the Medical Device Directive 93/42/EEC.

I have a doubt related to class I medical device::confused:

- Is compulsory or not the registration to the Spanish Databank AMPS?
- Is it required any kind of notification or sending some documents to the competent authority, before starting commercialization of product in Spain?
- Do you know a regulation / guideline of "Ministerio de Sanidad, Servicios Sociales e Igualdad" in which it is written the procedure to register this class of medical devices?

Thank you in adavance for the help!
Bye bye:bigwave:
 

pkost

Trusted Information Resource
Re: Spain Class I Medical Device Regisatration

You dont say in your post where you are based. If you are outside of Spain and inside the EU, provided you have valid CE mark I don't beleive you have to do anything for Class I

If you are a spanish manufacturer you will have to notify the competent authority (I'm not sure on the mechanism)

The transposed law in Spain is Royal Decree (RD) 1591/2009. This should give you the information you need. Alternatively you could call the competent authority!
 
M

MD_Simy86

Re: Spain Class I Medical Device Regisatration

Hi pkost,
thank you for the information provided!

Yes I haven't specified the place of the Manufacturer, sorry!
So the Manufacturer is located in Italy (so it belongs to the European Union) and its class I medical device has the CE Certificate.

In order to understand: this Manufacturer doesn't have to do anything to sell its class I product in Spain, can you confirm that?

Bye bye:bigwave:
 
M

MD_Simy86

Re: Spain Class I Medical Device Regisatration

Hi evilchilli_420,
thank you so much for the reply!!

Now it is clear!!

See you:bigwave:
 

xcanals_tecno-med.es

Involved In Discussions
Sorry I'm not see this Spanish question before ...

For class I devices you only need to register them in Spain if you are a Manufacturer or an European Representative located in Spain

The registration procedure does not follows the PMPS database which is for class IIa, IIb and III (fee 100 Eur)

The registration is made in the RPS database with no fee

https://sede.aemps.gob.es/en/PSCH/PS/rrps.htm

Regards

Xavier
 
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M

MD_Simy86

Dear Mr. Xavier,
thnak you so much for your clarification!

Hav a nice day,
best regards,
Simona.:bigwave:
 
J

jennaleeb

Hi there! We are a Canadian manufacturer with CE Mark (Class I non-sterile). Our product got stopped at the border because there was some problem with an "import license" ?

I am under the impression that if we are CE marked we do not have to do any additional registration? Do we require a local agent or local distributor?

Any help will be appreciated!
 

Ronen E

Problem Solver
Moderator
Hi there! We are a Canadian manufacturer with CE Mark (Class I non-sterile). Our product got stopped at the border because there was some problem with an "import license" ?

I am under the impression that if we are CE marked we do not have to do any additional registration? Do we require a local agent or local distributor?

Any help will be appreciated!

Hi,

I assume that you don't have an EC-based operation (registaered place of business), so you must designate an EC Authorized Representative (AR), who must register your non-sterile class I device with the Competent Authority in the Member State where the AR has their registered place of business.

The registration is mostly an administrative process, and involves basic information such as the address of the AR and the name/type of the device.

Refer to Article 14 of the MDD.

2. Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union. For devices referred to in the first subparagraph of paragraph 1, the authorised representative shall inform the competent authority of the Member State in which he has his registered place of business of the details referred to in paragraph 1.

Cheers,
Ronen.
 
J

jennaleeb

Hi Ronen - we do have an AR based in the UK who has registered our device with the competent authority.

Apparently the issue is on the importer side - ie our customer does not have an import license for importing medical devices in Spain?!

Any ideas?

Jenna
 
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