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Since 1 May 2007, registration in the national Database of Medical Devices (BD/RDM) met the procedures established by the Ministerial Decree of 21 December 2009.

• manufacturers of medical devices, as defined in Article 1, paragraph 2, letter f) of Legislative Decree No 46 of 24 February 1997;
• entities referred to the Article 12, paragraphs 2 and 3 of Legislative Decree No 46 of 24 February 1997;
• other entities responsible for placing medical devices on the market (Authorised representative);
• entities validly authorised by the actors referred to the points above.

Summary table for the registration requirements for medical and active implantable devices

The Database (BD/RDM), including the subset of database called “Repertorio”, constitutes a collection of information provided by:

• Manufacturers,
• Authorised representatives,
• Entities who carry out activities according to the Article 12, para. 2 (called assemblers in the User Manual Medical Device Manufacturer Profile),
• Other entities authorised by the actors indicated above.

Whoever makes the registration assumes full responsibility for the information provided, regarding both general data and data relating to each medical devices (MDs).

The publication of the data does not constitute any form of approval by the Ministry.

The Directorate General of Medical Devices and Pharmaceutical Service has the right to carry out checks at any time on declarations made and on registered medical devices, as established by Legislative Decree No 46 of 24 February 1997 and subsequent amendments.

In the Database of Medical Devices, entities who enter the data directly are considered “registrants”. Only registrants can change the information relating to medical devices that they have registered.

All information, initially acquired by the system in processing status “L”, must be “validated” by electronic signature in order to be “published”.

Since 1 January 2014, with regard to the processing status (“L”), there has been a time limit in force for the completion of data notifications. The system applies a different time limit in relation to the “Processing Start Date”:

• First notification
  The “First notification” of a medical device must be completed, according to the procedures required by the law in force and in any case with the electronic signature of the data, no later than 30 calendar days from the date of data entry. Beyond this deadline, in the absence of validation by electronic signature, the data entered will be deleted from the BD/RDM system including the progressive number initially assigned by the system following registration.

• Subsequent notifications
  The “Subsequent notifications” of a medical device, resulting from changes to the data previously entered in the system, must be concluded by electronic signature, no later than 7 calendar days from the date of "return to processing”. Beyond this deadline, in the absence of due validation, the changes made are considered null, deleted from the system and the previous notification remains valid to all effects and purposes.

• Further features for users
  If the system detects notifications in processing status in the Database, they are listed in the relative section: Notifications to be completed (To-do List).

As well as in the Database, devices can also be registered in the subset of database called “Repertorio” or “Repertoire” in the User Manual Medical Device Manufacturer Profile. Registering a medical device in the “Repertorio” is not mandatory and it is free of charge.

Please note that the registration in the “Repertorio” gives the Regions and the Autonomous Provinces of Trento and Bolzano as well as the operators of the National Health Service full visibility of the information on the registered medical devices.

To do this, just click on “Register in the Repertoire”. This function can also be activated after the validation of the data by approved electronic signature.

In order to register medical devices in the BD/RDM, the Database must be accessed according to the two possible alternative paths defined below (A and B). The company that operates directly in the BD/RDM is defined as a “registrant company”; a registrant company can be:

1. manufacturer of medical devices, as defined in Article 1, paragraph 2, letter f) of Legislative Decree 46/97;
2. entity referred to the Article 12, paragraph 2 of Legislative Decree 46/97 (called assembler);
3. authorised representative in the EU designated by the manufacturer, as referred to the Article 13, paragraph 2 of Legislative Decree 46/97;
4. entity validly authorised by the figures referred to the points 1, 2 and 3.

Once access is allowed, company can enter data of the devices.

Accessing the BD/RDM

• A - Direct access to the Database of Medical Devices
  
• B - Access by mandate to the Database of Medical Devices
  

Registering devices in the BD/RDM

Before being able to proceed with the registration of medical devices, you must access the Database of Medical Devices according to the instructions given in the previous section “Accessing the BD/RDM”.

About procedures in order to register medical devices, please see the instructions in the User Manual Medical Device Manufacturer Profile. We remind you that the registration of medical device is mandatory or optional depending on the risk class of the medical devices and the registered address of the parties responsible for placing them on the market. For further information, please see Requirements for registration.

Your company, as a manufacturer, authorised representative, assembler wants to access directly and therefore be considered a registrant in the BD/RDM.

Access for Italian companies

If your company is registered in Italy: access the Database via impresainungiorno.gov.it

The Database is accessed via the online Medical Devices service at impresainungiorno.gov.it under Servizi integrati di impresa.gov - La mia scrivania.

The online service can be accessed via SPID (Public Digital Identity System), CIE (Electronic Identity Card) or CNS (National Services Card).

The legal representatives of the companies concerned are directly authorized to use the service; moreover, the legal representative of a company can authorise one or more trusted persons to operate on the online Medical Devices service.

To delegate, the legal representative must use the sub-delegation services available on the business portal under Servizi Integrati at impresainungiorno.gov.it - Gestione Subdeleghe.

At the end of this procedure,users will have access to the functions for managing medical devices for which they have been authorised.

For registering a medical device, the authorised person must have a qualified electronic signature issued by one of the approved certifiers in Italy or in compliance with the provisions of Regulation (EU) No 910 / 2014- The eIDAS (electronic IDentification Authentication and Signature). Instructions about entering data are provided in the User Manual Medical Device Manufacturer Profile.

Access for foreign companies

If your company is not registered in Italy: access the Database by sending the login credentials request form via email.

Procedure for requesting login credentials is:

1. Fill out the form FORM 1 - appointment of the person responsible
2. Send the form together with a copy of a valid document providing proof of identity of the legal representative of the company to: dgfdm@postacert.sanita.it
3. Once the Ministry of Health has verified that the form is complete, the person appointed to use the BD/RDM will receive two automatic emails sent to the email address indicated in the FORM 1:
   • the first one with the login credentials (User ID and password) for accessing the system for the first time,
   • the second one with confirmation that the “DM Manufacturer” profile has been enabled for the Medical Devices application.

N.B. Even if your company is not a manufacturer, for example an authorised representative, the profile enabling device data entry is called “DM Manufacturer”.

For using the BD/RDM and registering a medical device, the person responsible for entering data in the BD/RDM must have a qualified Electronic Signature issued by an approved certification body in Italy or in compliance with the provisions of Regulation (EU) No 910/2014 - The eIDAS (electronic IDentification Authentication and Signature) Regulation.

Your company, as a manufacturer, authorised representative or assembler, wants to authorise another entity to access the BD/RDM, who is considered the registrant, responsible for entering data.

Authorisation procedure

The authorisation can be made by a company (delegating company) to:

1. an authorised and registrant company that operates through a person responsible for entering data in the BD/RDM. The authorised and registrant company can be Italian or foreign
   
2. an authorised natural person responsible for entering data in the BD/RDM. The natural person in this case is self-employed and does not belong to a company; in case of employee, please see section “Direct access to the Database of Medical Devices”.
   

Italian authorised and registrant company

In the case of Italian authorised and registrant company - the authorisation procedure includes the following steps:

1. The Italian authorised and registrant company can access the BD/RDM via impresainungiorno.gov.it Please see the information provided for A - Direct access to the Database of Medical Devices, Access for Italian companies
2. The companies involved (delegating and authorised) must fill in the FORM 2 - Authorisation to the authorised company
3. The authorised and registrant company enters the duly completed mandate form in the Database of Medical Devices, following the instructions described in the “Mandates awarded (by manufacturers, Authorised Representatives and Assemblers to Registrants)” paragraph of the DM User Manual Medical Device Manufacturer Profile.

Foreign authorised and registrant company

In the case of a foreign authorised and registrant company - the authorisation procedure includes the following steps:

1. The companies involved (delegating and authorised) must fill in the FORM 2 - Authorisation to the authorised company
2. The registrant company sends the form together with the copies of valid document providing proof of identity of the legal representatives of the companies involved to: dgfdm@postacert.sanita.it
3. Once the Ministry of Health has verified that the form is complete, the person authorized to enter data in the BD/RDM will receive two automatic emails to the email address indicated in the FORM 2:
   • the first one with the login credentials (User ID and password) for accessing the system for the first time,
   • the second one with confirmation that the “DM Manufacturer” profile has been enabled for the Medical Devices application.
   If the person authorized to enter data in the BD/RDM has already get the login credentials, none automatic email will be sent. However, the FORM 2 must be uploaded to the Database of Medical Devices as indicated in Point 4 below.
4. The authorised and registrant company enters the duly completed mandate form (FORM 2) in the Database of Medical Devices, following the instructions described in the “Mandates awarded (by manufacturers, Authorised Representatives and Assemblers to Registrants)” paragraph of the User Manual Medical Device Manufacturer Profile.

N.B. Even if your company is not a manufacturer, for example an authorised representative, the profile enabling device data entry is called “DM Manufacturer”.

For using the BD/RDM and registering a medical device, the person responsible for entering data in the BD/RDM must have a qualified Electronic Signature issued by an approved certification body in Italy or in compliance with the provisions of Regulation (EU) No 910/2014 - The eIDAS (electronic IDentification Authentication and Signature) Regulation.

Authorised and registrant natural person

In the case of an authorised and registrant natural person - the authorisation procedure includes the following steps:

1. The delegating company and the authorised natural person fill in the FORM 3 - Authorisation to the natural person
2. The authorised and registrant natural person sends the form together with a copy of a valid document providing proof of identity: dgfdm@postacert.sanita.it
3. Once the Ministry of Health has verified that the form is complete, the natural person authorised to enter data in the BD/RDM will receive two automatic emails sent to the email address indicated in FORM 3:
   • the first one with the login credentials (User ID and password) for accessing the system for the first time,
   • the second one with confirmation that the “DM Manufacturer” profile has been enabled for the Medical Devices application.
   If the authorised natural person has already got the login credentials, none automatic email will be sent. However, the FORM3 must be uploaded to the Database of Medical Devices as indicated in Point 4 below.
4. The authorised and registrant natural person enters the duly completed mandate (FORM 3) in the Database of Medical Devices, following the instructions described in the “Mandates awarded (by manufacturers, Authorised Representatives and Assemblers to Registrants)” paragraph the User Manual Medical Device Manufacturer Profile.

N.B. Even if as an authorised natural person does not perform the role of manufacturer as required by law, the profile enabling device data entry is called "DM Manufacturer".

For using the BD/RDM and registering a medical device, the person responsible for entering data in the BD/RDM must have a qualified Electronic Signature issued by an approved certification body in Italy or in compliance with the provisions of Regulation (EU) No 910/2014 - The eIDAS (electronic IDentification Authentication and Signature) Regulation.

Changes to data already entered in the system

The data already entered in the system can only be changed by the registrant who entered the data. For instructions on how to change medical device registration data, please see the instructions in the User Manual Medical Device Manufacturer Profile.

In the case of changes to data entered by another registrant, please contact the Ministry of Health Support Service: SupportoRDM - supportoRDM@sanita.fvg.it.

The support service involves IT/administrative checks which require variable time.

Support for users is divided into several specialist support services according to type of query:

• accessing the system via impresainungiorno.gov.it (login support service);
• filling out datasheets with reference to the technical rules of the procedure and how to register a device (device registration support service);
• the methods of use and operation of the IT procedure and reporting malfunctions (technical support service).

Login support for Italian companies

For support and queries on accessing the system via impresainungiorno.gov.it, used by Italian companies, see website impresa.gov.it.

Device registration support

For questions and support regarding the technical rules of the procedure and how to register a device in the database and in the medical device subset of the database called “Repertorio” and how to change data already entered in the system, the Support Service of the Ministry of Health, SupportoRDM, due to the current health emergency and the change in working methods, from 2 November 2020, is available from Monday to Friday 9 am - 4 pm excluding holidays via e-mail at: supportoRDM@sanita.fvg.it.

Technical support

For information on how to log in to the system, using the application and reporting malfunctions of the IT procedures, you can contact the new Service Desk of the Ministry of Health at the toll-free number 800 178 178 at the following times:

from Monday to Sunday (24h 7/7), including holidays.

You can also send reports to the following e-mail address: servicedesk.salute@smi-cons.it

Data di ultimo aggiornamento 13 gennaio 2023