ANNEX VI – Information to be submitted upon the registration of devices and economic operators in accordance with articles 29(4) and 31, core data elements to be provided to the UDI database together with the UDI-DI in accordance with articles 28 and 29, and the UDI system

PART A

Information to be submitted upon the registration of devices and economic operators in accordance with articles 29(4) and 31

Manufacturers or, when applicable, authorised representatives, and, when applicable, importers shall submit the information referred to in Section 1 and shall ensure that the information on their devices referred to in Section 2 is complete, correct and updated by the relevant party.

1. Information relating to the economic operator

1.1 type of economic operator(manufacturer, authorised representative, or importer),

1.2 name, address and contact details of the economic operator,

1.3 where submission of information is carried out by another person on behalf of any of the economic operators mentioned under Section 1.1, the name, address and contact details of that person,

1.4 name address and contact details of the person or persons responsible for regulatory compliance referred to in Article 15.

2. Information relating to the device

2.1 Basic UDI-DI,

2.2 type, number and expiry date of the certificate issued by the notified body and the name or identification number of that notified body and the link to the information that appears on the certificate and was entered by the notified body in the electronic system on notified bodies and certificates,

2.3 Member State in which the device is to or has been placed on the market in the Union,

2.4 in the case of class IIa, class IIb or class III devices: Member States where the device is or is to be made available,

2.5 risk class of the device,

2.6 reprocessed single-use device (y/n),

2.7 presence of a substance which, if used separately, may be considered to be a medicinal product and name of that substance,

2.8 presence of a substance which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma and name of this substance,

2.9 presence of tissues or cells of human origin, or their derivatives (y/n),

2.10 presence of tissues or cells of animal origin, or their derivatives, as referred to in Regulation (EU) No 722/2012 (y/n),

2.11 where applicable, the single identification number of the clinical investigation or investigations conducted in relation to the device or a link to the clinical investigation registration in the electronic system on clinical investigations,

2.12 in the case of devices listed in Annex XVI, specification as to whether the intended purpose of the device is other than a medical purpose,

2.13 in the case of devices designed and manufactured by another legal or natural person as referred in Article 10(15), the name, address and contact details of that legal or natural person,

2.14 in the case of class III or implantable devices, the summary of safety and clinical performance,

2.15 status of the device (on the market, no longer placed on the market, recalled, field safety corrective action initiated).

MDR – Article 31 – Registration of manufacturers, authorised representatives and importers

Article 31

Registration of manufacturers, authorised representatives and importers

1. Before placing a device, other than a custom-made device, on the market, manufacturers, authorised representatives and importers shall, in order to register, submit to the electronic system referred to in Article 30 the information referred to in Section 1 of Part A of Annex VI, provided that they have not already registered in accordance with this Article. In cases where the conformity assessment procedure requires the involvement of a notified body pursuant to Article 52, the information referred to in Section 1 of Part A of Annex VI shall be provided to that electronic system before applying to the notified body.

2. After having verified the data entered pursuant to paragraph 1, the competent authority shall obtain a single registration number (‘SRN’) from the electronic system referred to in Article 30 and issue it to the manufacturer, the authorised representative or the importer.

3. The manufacturer shall use the SRN when applying to a notified body for conformity assessment and for accessing Eudamed in order to fulfil its obligations under Article 29.

4. Within one week of any change occurring in relation to the information referred to in paragraph 1 of this Article, the economic operator shall update the data in the electronic system referred to in Article 30.

5. Not later than one year after submission of the information in accordance with paragraph 1, and every second year thereafter, the economic operator shall confirm the accuracy of the data. In the event of a failure to do so within six months of those deadlines, any Member State may take appropriate corrective measures within its territory until that economic operator complies with that obligation.

6. Without prejudice to the economic operator’s responsibility for the data, the competent authority shall verify the confirmed data referred to in Section 1 of Part A of Annex VI.

7. The data entered pursuant to paragraph 1 of this Article in the electronic system referred to in Article 30 shall be accessible to the public.

8. The competent authority may use the data to charge the manufacturer, the authorised representative or the importer a fee pursuant to Article 111.

MDR – Article 30 – Electronic system for registration of economic operators

Article 30

Electronic system for registration of economic operators

1. The Commission, after consulting the MDCG, shall set up and manage an electronic system to create the single registration number referred to in Article 31(2) and to collate and process information that is necessary and proportionate to identify the manufacturer and, where applicable, the authorised representative and the importer. The details regarding the information to be provided to that electronic system by the economic operators are laid down in Section 1 of Part A of Annex VI.

2. Member States may maintain or introduce national provisions on registration of distributors of devices which have been made available on their territory.

3. Within two weeks of placing a device, other than a custom-made device, on the market, importers shall verify that the manufacturer or authorised representative has provided to the electronic system the information referred to in paragraph 1.

Where applicable, importers shall inform the relevant authorised representative or manufacturer if the information referred to in paragraph 1 is not included or is incorrect. Importers shall add their details to the relevant entry/entries.

MDR – Article 29 – Registration of devices

Article 29

Registration of devices

1. Before placing a device, other than a custom-made device, on the market, the manufacturer shall, in accordance with the rules of the issuing entity referred to in Article 27(2), assign a Basic UDI-DI as defined in Part C of Annex VI to the device and shall provide it to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device.

2. Before placing on the market a system or procedure pack pursuant to Article 22(1) and (3), that is not a custom- made device, the natural or legal person responsible shall assign to the system or procedure pack, in compliance with the rules of the issuing entity, a Basic UDI-DI and shall provide it to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that system or procedure pack.

3. For devices that are the subject of a conformity assessment as referred to in Article 52(3) and in the second and third subparagraphs of Article 52(4), the assignment of a Basic UDI-DI referred to in paragraph 1 of this Article shall be done before the manufacturer applies to a notified body for that assessment.

For the devices referred to in the first subparagraph, the notified body shall include a reference to the Basic UDI-DI on the certificate issued in accordance with point (a) of Section 4 of Chapter I of Annex XII and confirm in Eudamed that the information referred to in Section 2.2 of Part A of Annex VI is correct. After the issuing of the relevant certificate and before placing the device on the market, the manufacturer shall provide the Basic UDI-DI to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device.

4. Before placing a device on the market, other than a custom-made device, the manufacturer shall enter or if, already provided, verify in Eudamed the information referred to in Section 2 of Part A of Annex VI, with the exception of Section 2.2 thereof, and shall thereafter keep the information updated.