Database notifications for Medical Devices

The CE Certificate confirms that the medical device is verified and meets all regulatory requirements in the EU, a great achievement, but do not forget the additional notifications at the competent authorities.

Class I medical devices need to be registered with the competent authority of the country were you, as a manufacturer, are located. In case your company is outside the EU, this will be the country where your EU Authorized Representative (EAR) is Located.

A few EU members still require an additional national notification of all Class IIa, IIb and Class III and sometimes even Class I medical devices. To support medical device manufacturers with this mainly administrative process.

Qserve offers below mentioned EU database notification services:

Italy


The Italian Health Authority requires a database notification of all medical devices that a manufacturer wishes to market in Italy. This notification is executed through the 'Nuovo Sistema Informativo Sanitario' (NSIS) and a specific digital signature card system is needed to confirm the registration. Use your precious time for other regulatory challenges and delegated this task to Qserve.

Notification requires between 4 and 10 hours per device depending on availability and quality of the mandatory documentation as well as the complexity of the device influenced by the number of models, components, accessories, manufacturing sites.

Spain

The Spanish Health AuthorIty (AEMPS) requires a database notification of all medical devices, except for Class I classified devices, that are marketed in Spain. This notification is executed through the 'Puesta en Servicio de Productos Sanitarios' ( PMPS) system. Qserve has access to this online system and notifies medical devices as authorized by medical device manufacturers.

Notification requires between 4 and 10 hours per device depending on availability and quality of the documentation required and the complexity of the device regarding components, accessories, manufacturing sites.

 

Qserve takes care of your mandatory EU Medical Device database notifications in Italy, Spain, Portugal and French email notification.

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Portugal

The Portuguese Health Authority (Infarmed) requests several database notifications of both national and foreign manufacturers. Foreign manufacturers, or their European Authorized Representatives (EAR) in case they are located outside of the EU, that intend to put class IIa, IIb, III and implantable active medical devices on the Portuguese market must register their devices through the online notification system. Qserve will create an account for the manufacturers and takes care of the whole notification procedure.

Notification requires between 4 and 10 hours per device depending on availability and quality of the mandatory documentation as well as the complexity of the device influenced by the number of models, components, accessories, manufacturing sites. 

 

France

ANSM, the French Health Authority that is responsible for the identification of all medical devices that enter the French territory, requires notification of class IIa, IIb, III and active implantable medical devices. There is no online database system in France, but all manufacturers are required to inform ANSM by email. An application form must be included in this email message as well as all mandatory documentation. Use your precious time for other regulatory challenges and delegated this task to Qserve.

Notification requires between 2 and 6 hours per device depending on availability and quality of the mandatory documentation as well as the complexity of the device influenced by the number of models, components, accessories, manufacturing sites.

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