Extra-EU actors registration

Home / Argomenti - Banca dati europea EUDAMED / Extra-EU actors registration

Extra-EU actors registration

Data di ultimo aggiornamento 27 giugno 2024

The Ministry of Health in Italy (MoH) is the Competent Authority (CA) for medical devices and in vitro diagnostic medical devices. MoH recognises the voluntary use of Eudamed by economic operators.

The mandatory use of Eudamed is expected to run from the date corresponding to six months from the date of publication of the notice in the Official Journal of the European Union about the full functionality of Eudamed (see the Article 123.3 (d)/MDR and 113.3 (f) IVDR).

Considering the above provision and that Italy will have to maintain the obligation to registering in the Italian national database as long as the law provides it, companies can voluntarily register themselves into Eudamed.

According to the Regulations, Competent Authorities are required to verify and validate the data of economic operators registering in Eudamed in order to approve the registration request and allow the economic operator to obtain the SRN. It should also be noted that the Regulations do not provide for specific timeframes for the verification and validation of applications in Eudamed by the Competent Authorities.

In order to proceed with registration, companies with actor roles as manufacturers, authorised representatives, importers, systems and procedure pack producers (SPPP) can read indications in the EUDAMED Economic Operator user guide available on the Commission's website.

For more details on the obligations and related rules for the registration in Eudamed of actors other than manufacturers, authorised representatives and importers, please refer to document MDCG 2021-13.

For more information on Eudamed, please visit the European Commission webpage: Eudamed overview

All registration applications received on Eudamed for Italian based economic operators and their associated non-EU manufacturers must be validated by the Ministry of Health. Incomplete registration applications will be returned to the economic operator for completion. Once validated, the economic operator will receive a single registration number (SRN) issued by Eudamed.

The Italian Ministry of Health requires the following information for a successful application on Eudamed from extra EU Manufacturer and extra EU SPPP

Extra EU Manufacturer

STEP 1 - Actor identification

Role
Country
Organisation name – indicate the name as indicated in the Organisation identification document; indicate additional or abbreviated name in the field “Abbreviated organisation name”
VAT Information, if applicable
EORI number, if applicable
National Trade Register number in the National Trade Register field, if applicable
Organisation identification document specific to non-EU manufacturer's address. The document shall be uploaded in English. Examples include the following:
- Proof of registration with national trade register within the non-EU manufacturer's jurisdiction or
- A notarised document confirming the company name, location and contact details for the company director/manager.

STEP 2 - Authorised Representative

Authorised representative information, including SRN.
Mandate validity dates
Upload the mandate summary document - The mandate summary template is available in the European Commission website (Actor registration module); please include all the following information:
- Non-EU manufacturer’s signature (Include printed contact name).
- Authorised representative’s signature (Include printed contact name).

STEP 3 - Actor address

Street information – indicate the address of the registered place of business as indicated in the Organisation identification document
Street number
City name
Postal code
Country

STEP 4 - Actor contact details

Contact details for Competent Authorities

First name
Last name
Email
Telephone

Public contact details

STEP 5 - Regulatory Persons– In case the person responsible for regulatory compliance is not within the organisation, it is required to indicate a declaration in the free text box at the STEP 7 that the organisation is a micro or small enterprise within the meaning of Commission Recommendation 2003/361/EC. According to the article 15(2)/MDR and IVDR, micro or small enterprises shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal.

First name
Last name
Email
Telephone number
Responsible for – In case of two or more persons are jointly responsible for regulatory compliance indicate the respective areas of responsibility according to the article 15(3)/MDR and IVDR.
City name
Postal code
Country.

STEP 6 - Registering Local Actor Administrator

Indicate data already used in the EU Login details. Eu Login is linked to a professional e-mail; please do not use generic email address linked to a shared mail box.

EUDAMED personal data

First name
Last name

EUDAMED email of the user for the actor

Signed declaration – upload the declaration filling out all of the fields required

Are you sub-contractor for this actor?

NO/YES

In case you are a sub-contractor indicate the following

Company name – indicate the name as indicated in the Organisation identification document
Telephone number
Company email address
Street – indicate the address of the registered place of business as indicated in the Organisation identification document
Street number
City name
Postal code
Country

STEP 7 - Competent Authority

Select the Competent Authority which will validate this actor
Any other information of significance for the competent authority – indicate if you are a manufacturer of medical devices, IVD or both; in case of external PRRC indicate a declaration as required in the indication at the STEP 5.

In case of incomplete applications, the application will be 'not approved' as 'incomplete or incorrect'. For more information on the stages afterwards the rejection, please refer to the EUDAMED Economic Operator user guide.

Extra EU SPPP

Extra EU SPPP are required to follow the instructions above for the applicable STEPs in Eudamed.

In addition, the Italian Ministry of Health requires the following information in the STEP 5 for a successful application on Eudamed:

STEP 5 - Competent Authority

We recall that according to the guidance MDCG 2021-13, the Competent Authority to be chosen by a non-EU SPPP is:

the authority of the place where the first system or procedure pack is to be placed on the market OR
in case the non-EU SPPP acts also as a non-EU manufacturer, who has an authorised representative already designated, the authority responsible for the authorised representative should be the authority responsible for the approval of the non-EU SPPP actor registration request.

Select the competent authority which will validate this actor
Any other information of significance for the Competent Authority – Indicate the reason for which the Competent Authority is chosen:
- CA of the place where the first system or procedure pack is to be placed on the market;
- CA of the authorised representative already designated by the SPPP who acts also as a non-EU manufacturer.