研讨会和活动
Obligations
Economic operators and health institutions
According to the two medical devices Regulations, manufacturers shall be responsible for the UDI assignment and placement of the UDI carrier, the initial submission and updates of the identifying information and other device data elements in the EUDAMED database. Manufacturers shall update the relevant database record within 30 days of a change being made to an element, which does not require a new UDI-DI.
Distributors and importers shall verify that, where applicable, a UDI has been assigned by the manufacturer.
All economic operators and health institutions shall store and keep, preferably by electronic means, the UDI of the devices which they have supplied, or with which they have been supplied, if those devices belong to class III implantable devices. Please note that the Commission may decide to adopt implementing acts to expand the scope of devices for which economic operators shall store and keep the UDI.
There are circumstances where distributors, importers or other natural or legal persons assume the obligations incumbent on manufacturers. This is in accordance with Article 16(1) where actions by these actors such as making a device available on the market under their own name, registered trade name or registered trade mark will require them to assume all the relevant responsibilities related to UDI, including UDI labelling.
Exception: the exception to this rule also outlined in Art.16.1(a) MDR/IVDR:
''...except in cases where 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"
In the above case, "responsible" refers to legal responsibility. As such, where under agreement the manufacturer is identified as such on the label, he/she is considered to be the legal manufacturer and will therefore be ultimately and legally responsible for fulfilling UDI obligations of the MDR/IVDR. This does not in principle prevent the legal manufacturer from entrusting the performance or ‘operational responsibility’ of such activities (on his behalf) including UDI assignment and application to a third party, e.g. via a contractual agreement.
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Who are considered the economic operators allowed to issue identifiers (UDI and Basic UDI-DI) to the medical devices for implementation of the UDI requirements as defined by the MDR and IVDR, and
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Who are considered the economic operators legally responsible for compliance with the UDI requirements as defined by the MDR and IVDR.
The distributor or importer carrying out the operations described in Article 16(2) (providing translation or repackaging of devices) shall ensure that:
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The activities are performed by means and under conditions that in no way compromise the readability of the UDI carrier and its information identifying the actual device.
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The specific procedures are part of the distributor’s or importer’s quality management system.
A dedicated guideline with additional information on this aspect is available in the MDCG 2018-6 guidance document.
The MDR/IVDR only set out the actor legally responsible actor for UDI obligations but does not provide instruction regarding any arrangement whereby additional actors execute activities such as UDI application and assignment to medical devices on behalf of the actor who holds the legal responsibility. As such, the manufacturer may in principle delegate the practical operation of UDI assignment and application to a third party (e.g. under a contractual agreement), however the ultimate legal liability for complying with UDI Obligations remains with the manufacturer.