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General principles In consideration of the following: - In accordance with Article 28(3) MDR and Article 25(3) IVDR, the core data elements to be provided to the UDI database shall be accessible to the public, - Annex VI Part C of the MDR and IVDR on the UDI System requires explicitly in its section 5.10 that the user interface of the UDI database shall be available in all official languages of the Union and that the use of free- text fields shall, however, be minimized in order to reduce translations, - one of the main declared purposes of the European database on medical devices (Eudamed) as per Recitals 43-46 and Article 33(1a) of the MDR and Recitals 40-43 of the IVDR is to enable the public (including the healthcare professionals) to be adequately informed about devices placed on the market, it is essential that the information in the UDI database is publicly available and easily understandable by any European citizen.

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Relevant obligations arising from Article 16(1) Any distributor, importer or other natural or legal person that assumes the obligations incumbent on manufacturers in accordance with Article 16(1), assumes all the relevant responsibilities related to UDI, including UDI labelling. This means that those economic operators must also apply for registration as Manufacturers, receive a Single Registration Number (SRN), apply for the appropriate conformity assessment procedure and feed and provide UDI-product registration. However, in accordance with the provision of Article 16(1)a, when a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label, the manufacturer is responsible for meeting the requirements placed on manufacturers in this Regulation, including the relevant UDI obligations.

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In accordance with Annex VI, Part C of the Medical Device Regulation (EU) 2017/745 (MDR) and the In-Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR), only software which is commercially available on its own as well as software which constitutes a device in itself shall be subject to UDI requirements.

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This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.

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This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.