Another question if have some time...
The RD specifies that it applies to products within scope of Article 1 of the MDR 2017/745 (Art. 3 1.a). The MDR Article 1 says it does not apply to IVDs (Chp 1, Art 1, 6(a)). But you are stating that IVDs will need to be registered in the Spanish AEMPS medical devices database, all classes. Can you point out where the RD states that this applies to IVDs please?
Original Message:
Sent: 23-Mar-2023 12:39
From: Xavier Canals-Riera
Subject: New Spanish Medical Devices Royal Decree
Dear Richard
Yes, the medical devices sold in Spain must be registered in the Spanish AEMPS medical devices database "Registro de Comercialización" (all classes MDR and IVDR). Note that the RD establishes that this will be required when the new database is operational (and has published in another Decree the fees for this new database)
This requirement is only new for the class I and class A devices which are added, before only Spanish manufacturers must be registered.
The old databases are RPS https://sede.aemps.gob.es/PSCH/PS/rrps.html and the CCPS https://sede.aemps.gob.es/PSCH/PS/ccps.html
But note that Spain is not the only country with device databases Portugal (INFARMED), Italy, ...
Will be nice to compile a national requirements list from all the European RAPS members
And I agree with you EUDAMED must be the main reference
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Xavier Canals-Riera
Director
Tecno-med Ingenieros
Medical Devices Consultants
Barcelona Spain
https://www.tecno-med.es
xcanals@tecno-med.es
+34 932917739
Original Message:
Sent: 21-Mar-2023 04:55
From: Richard Vincins
Subject: New Spanish Medical Devices Royal Decree
Hello Xavier,
Just a clarification before a smack my forehead ... does this mean all medical devices placed on the market, sold in Spain require registration in the AEMPS? Is this not why EUDAMED was put in place, so individual country registrations would not be required?
Thank you for the information, I think, haha. But really thank you, it is extremely helpful for individual countries to have this regulatory intelligence as we get those nice Easter Egg surprises when going to market and sell in a country. When this does get published a provided link would be excellent as these type of information is really helpful for assisting medical device companies, especially those located outside of the European Union.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 20-Mar-2023 12:53
From: Xavier Canals-Riera
Subject: New Spanish Medical Devices Royal Decree
Dear all
Today the Council of Ministers has approved the Royal Decree that establishes the additional requirements to the MDR Regulation in Spain.
It includes specific requirements relating to:
- licences for manufacturers, importers, consolidators and distributors established in Spain.
- registration of products in the new AEMPS database Registro de Comecializacion de la AEMPS (Marketing Register)
- requirements for IFU and labelling
Soon to be published in the BOE (Spanish Official Journal)
Best regards
Estimados
Hoy el Consejo de Ministros ha aprobado el Real Decreto que establece los requisitos adicionales al Reglamento MDR en España.
Incluye requsitos especificos relativos a:
- licencias para fabricantes, importadores, agrupadores y distribuuidores establecidos en España.
- registro de productos en la nueva base de datos Registro de Comecializacion de la AEMPS
- requisitos para las IFU y etiquetado
En breve se publicará en el BOE
Un abrazo
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Xavier Canals-Riera
Director
Tecno-med Ingenieros
Medical Devices Consultants
Barcelona Spain
https://www.tecno-med.es
xcanals@tecno-med.es
+34 932917739
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