Spain Local Networking Group

Dear all
As the approval and publication of the new Royal Decree that will update the additional Spanish requirements for medical devices is near, I think it may be useful to share information about this new Royal Decree.
Attached is the text submitted to the European Commission. The expected date of publication is January 2023

Hola a todos
Como la aprobación y publicación del nuevo Real Decreto que actualizará los requisitos adicionales españoles a los productos sanitarios esta cerca, pineso que puede ser util compartir informacion sobre este nuevo Real Decreto. 
Anexo el texto presentado a la Comision Europea. La fecha esperada de publicación es en Enero de 2023


------------------------------
Xavier Canals-Riera
Director Tecno-med Ingenieros
Barcelona Spain
xcanals@tecno-med.es
------------------------------

Thank you for sharing Xavier!

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Nuria Cervera
BARCELONA
Spain
------------------------------

Original Message:
Sent: 27-Nov-2022 14:45
From: Xavier Canals-Riera
Subject: New Spanish Medical Devices Royal Decree

Dear all
As the approval and publication of the new Royal Decree that will update the additional Spanish requirements for medical devices is near, I think it may be useful to share information about this new Royal Decree.
Attached is the text submitted to the European Commission. The expected date of publication is January 2023

Hola a todos
Como la aprobación y publicación del nuevo Real Decreto que actualizará los requisitos adicionales españoles a los productos sanitarios esta cerca, pineso que puede ser util compartir informacion sobre este nuevo Real Decreto.
Anexo el texto presentado a la Comision Europea. La fecha esperada de publicación es en Enero de 2023


------------------------------
Xavier Canals-Riera
Director Tecno-med Ingenieros
Barcelona Spain
xcanals@tecno-med.es
------------------------------

Thanks for sharing, Xavier! Much appreciated!

------------------------------
Carlos Gil Guzmán
La Pobla de Vallbona
Spain
------------------------------

Original Message:
Sent: 27-Nov-2022 14:45
From: Xavier Canals-Riera
Subject: New Spanish Medical Devices Royal Decree

Dear all
As the approval and publication of the new Royal Decree that will update the additional Spanish requirements for medical devices is near, I think it may be useful to share information about this new Royal Decree.
Attached is the text submitted to the European Commission. The expected date of publication is January 2023

Hola a todos
Como la aprobación y publicación del nuevo Real Decreto que actualizará los requisitos adicionales españoles a los productos sanitarios esta cerca, pineso que puede ser util compartir informacion sobre este nuevo Real Decreto.
Anexo el texto presentado a la Comision Europea. La fecha esperada de publicación es en Enero de 2023


------------------------------
Xavier Canals-Riera
Director Tecno-med Ingenieros
Barcelona Spain
xcanals@tecno-med.es
------------------------------

Many thanks for sharing Xavier very much appreciated.

Pilar Corraliza Perez
Regulatory Affairs & Clinical Research Services
Mobile 727787065
e-mail: pilarcorralizap@gmail.com
e-mail: pilar.corraliza@regpharma.net

Enviado desde mi iPhone


Original Message:
Sent: 11/28/2022 6:15:00 AM
From: Carlos Gil Guzmán
Subject: RE: New Spanish Medical Devices Royal Decree

Thanks for sharing, Xavier! Much appreciated!

------------------------------
Carlos Gil Guzmán
La Pobla de Vallbona
Spain
------------------------------

Original Message:
Sent: 27-Nov-2022 14:45
From: Xavier Canals-Riera
Subject: New Spanish Medical Devices Royal Decree

Dear all
As the approval and publication of the new Royal Decree that will update the additional Spanish requirements for medical devices is near, I think it may be useful to share information about this new Royal Decree.
Attached is the text submitted to the European Commission. The expected date of publication is January 2023

Hola a todos
Como la aprobación y publicación del nuevo Real Decreto que actualizará los requisitos adicionales españoles a los productos sanitarios esta cerca, pineso que puede ser util compartir informacion sobre este nuevo Real Decreto.
Anexo el texto presentado a la Comision Europea. La fecha esperada de publicación es en Enero de 2023


------------------------------
Xavier Canals-Riera
Director Tecno-med Ingenieros
Barcelona Spain
xcanals@tecno-med.es
------------------------------

Many thanks Xavier for the document. It is very usefull.
If someone has the English version of text submitted to the European Commission, I appreciate if you can share it.
Best regards and thanks again.

------------------------------
Pilar Rocha
Trinity Solutions S.L.
Madrid
Spain
------------------------------

Original Message:
Sent: 27-Nov-2022 14:45
From: Xavier Canals-Riera
Subject: New Spanish Medical Devices Royal Decree

Dear all
As the approval and publication of the new Royal Decree that will update the additional Spanish requirements for medical devices is near, I think it may be useful to share information about this new Royal Decree.
Attached is the text submitted to the European Commission. The expected date of publication is January 2023

Hola a todos
Como la aprobación y publicación del nuevo Real Decreto que actualizará los requisitos adicionales españoles a los productos sanitarios esta cerca, pineso que puede ser util compartir informacion sobre este nuevo Real Decreto.
Anexo el texto presentado a la Comision Europea. La fecha esperada de publicación es en Enero de 2023


------------------------------
Xavier Canals-Riera
Director Tecno-med Ingenieros
Barcelona Spain
xcanals@tecno-med.es
------------------------------

Dear Pilar 
As Spain is a member of the EU no translations are needed to submit documents to the Commision 
Regards

Estimada Pilar 
Como España es un miembro de la UE no se precisan traducciones para la presentacion de documentos a la Comisión 
Saludos

------------------------------
Xavier Canals-Riera
Director Tecno-med
Barcelona Spain
xcanals@tecno-med.es
------------------------------

Original Message:
Sent: 28-Nov-2022 11:10
From: Pilar Pina
Subject: New Spanish Medical Devices Royal Decree

Many thanks Xavier for the document. It is very usefull.
If someone has the English version of text submitted to the European Commission, I appreciate if you can share it.
Best regards and thanks again.

------------------------------
Pilar Rocha
Trinity Solutions S.L.
Madrid
Spain

Original Message:
Sent: 27-Nov-2022 14:45
From: Xavier Canals-Riera
Subject: New Spanish Medical Devices Royal Decree

Dear all
As the approval and publication of the new Royal Decree that will update the additional Spanish requirements for medical devices is near, I think it may be useful to share information about this new Royal Decree.
Attached is the text submitted to the European Commission. The expected date of publication is January 2023

Hola a todos
Como la aprobación y publicación del nuevo Real Decreto que actualizará los requisitos adicionales españoles a los productos sanitarios esta cerca, pineso que puede ser util compartir informacion sobre este nuevo Real Decreto.
Anexo el texto presentado a la Comision Europea. La fecha esperada de publicación es en Enero de 2023


------------------------------
Xavier Canals-Riera
Director Tecno-med Ingenieros
Barcelona Spain
xcanals@tecno-med.es
------------------------------

As the last step in the approval process of the Royal Decree on medical devices, the standing committee of  the Consejo de Estado has issued its opinion 1564/2022 on the decree. Now the AEMPS will review it and it will go to the Council of Ministers for approval and publication in the Spanish Official Journal BOE.
Best regards

Como último paso del proceso de aprobación del Real Decreto de productos sanitarios la comisión permanente del Consejo de Esado ha emitido su dictamen 1564/2022 sobre este. Ahora la AEMPS lo revisará y ya pasa a Consejo de Ministros para su aprobación y publicación en el BOE.
Un abrazo

https://www.tecno-med.es/rd-ps-dictamen-consejo-estado/ 

------------------------------
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: 30-Nov-2022 19:42
From: Xavier Canals-Riera
Subject: New Spanish Medical Devices Royal Decree

Dear Pilar
As Spain is a member of the EU no translations are needed to submit documents to the Commision
Regards

Estimada Pilar
Como España es un miembro de la UE no se precisan traducciones para la presentacion de documentos a la Comisión
Saludos

------------------------------
Xavier Canals-Riera
Director Tecno-med
Barcelona Spain
xcanals@tecno-med.es

Original Message:
Sent: 28-Nov-2022 11:10
From: Pilar Pina
Subject: New Spanish Medical Devices Royal Decree

Many thanks Xavier for the document. It is very usefull.
If someone has the English version of text submitted to the European Commission, I appreciate if you can share it.
Best regards and thanks again.

------------------------------
Pilar Rocha
Trinity Solutions S.L.
Madrid
Spain

Original Message:
Sent: 27-Nov-2022 14:45
From: Xavier Canals-Riera
Subject: New Spanish Medical Devices Royal Decree

Dear all
As the approval and publication of the new Royal Decree that will update the additional Spanish requirements for medical devices is near, I think it may be useful to share information about this new Royal Decree.
Attached is the text submitted to the European Commission. The expected date of publication is January 2023

Hola a todos
Como la aprobación y publicación del nuevo Real Decreto que actualizará los requisitos adicionales españoles a los productos sanitarios esta cerca, pineso que puede ser util compartir informacion sobre este nuevo Real Decreto.
Anexo el texto presentado a la Comision Europea. La fecha esperada de publicación es en Enero de 2023


------------------------------
Xavier Canals-Riera
Director Tecno-med Ingenieros
Barcelona Spain
xcanals@tecno-med.es
------------------------------