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Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance)
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Version Superseded: 31/12/2020
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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.
type of economic operator(manufacturer, authorised representative, or importer),
name, address and contact details of the economic operator,
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,
name address and contact details of the person or persons responsible for regulatory compliance referred to in Article 15.
Basic UDI-DI,
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,
Member State in which the device is to or has been placed on the market in the Union,
in the case of class IIa, class IIb or class III devices: Member States where the device is or is to be made available,
risk class of the device,
reprocessed single-use device (y/n),
presence of a substance which, if used separately, may be considered to be a medicinal product and name of that substance,
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,
presence of tissues or cells of human origin, or their derivatives (y/n),
presence of tissues or cells of animal origin, or their derivatives, as referred to in Regulation (EU) No 722/2012 (y/n),
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,
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,
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,
in the case of class III or implantable devices, the summary of safety and clinical performance,
status of the device (on the market, no longer placed on the market, recalled, field safety corrective action initiated).
The manufacturer shall provide to the UDI database the UDI-DI and all of the following information relating to the manufacturer and the device:
quantity per package configuration,
the Basic UDI-DI as referred to in Article 29 and any additional UDI-DIs,
the manner in which production of the device is controlled (expiry date or manufacturing date, lot number, serial number),
if applicable, the unit of use UDI-DI (where a UDI is not labelled on the device at the level of its unit of use, a ‘unit of use’ DI shall be assigned so as to associate the use of a device with a patient),
name and address of the manufacturer (as indicated on the label),
the SRN issued in accordance with Article 31(2),
if applicable, name and address of the authorised representative (as indicated on the label),
the medical device nomenclature code as provided for in Article 26,
risk class of the device,
if applicable, name or trade name,
if applicable, device model, reference, or catalogue number,
if applicable, clinical size (including volume, length, gauge, diameter),
additional product description (optional),
if applicable, storage and/or handling conditions (as indicated on the label or in the instructions for use),
if applicable, additional trade names of the device,
labelled as a single-use device (y/n),
if applicable, the maximum number of reuses,
device labelled sterile (y/n),
need for sterilisation before use (y/n),
containing latex (y/n),
where applicable, information labelled in accordance with Section 10.4.5 of Annex I,
URL for additional information, such as electronic instructions for use (optional),
if applicable, critical warnings or contra-indications,
status of the device (on the market, no longer placed on the market, recalled, field safety corrective action initiated).
AIDC is a technology used to automatically capture data. AIDC technologies include bar codes, smart cards, biometrics and RFID.
The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity.
The Unit of Use DI serves to associate the use of a device with a patient in instances in which a UDI is not labelled on the individual device at the level of its unit of use, for example in the event of several units of the same device being packaged together.
A configurable device is a device that consists of several components which can be assembled by the manufacturer in multiple configurations. Those individual components may be devices in themselves.
Configurable devices include computed tomography (CT) systems, ultrasound systems, anaesthesia systems, physiological Monitoring systems, radiology information systems (RIS).
Configuration is a combination of items of equipment, as specified by the manufacturer, that operate together as a device to achieve an intended purpose. The combination of items may be modified, adjusted or customized to meet specific needs.
Configurations include inter alia:
gantries, tubes, tables, consoles and other items of equipment that can be configured/combined to deliver an intended function in computed tomography.
ventilators, breathing circuits, vaporizers combined to deliver an intended function in anaesthesia.
The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is also used as the ‘access key’ to information stored in a UDI database.
HRI is a legible interpretation of the data characters encoded in the UDI carrier.
Packaging levels means the various levels of device packaging that contain a defined quantity of devices, such as a carton or case.
The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production.
The different types of UDI-PIs include serial number, lot number, software identification and manufacturing or expiry date or both types of date.
RFID is a technology that uses communication through the use of radio waves to exchange data between a reader and an electronic tag attached to an object, for the purpose of identification.
A shipping container is a container in relation to which traceability is controlled by a process specific to logistics systems.
The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. It allows the unambiguous identification of a specific device on the market. The UDI is comprised of the UDI-DI and the UDI-PI.
The word ‘Unique’ does not imply serialisation of individual production units.
The UDI carrier is the means of conveying the UDI by using AIDC and, if applicable, its HRI.
UDI carriers include, inter alia, ID/linear bar code, 2D/Matrix bar code, RFID.
name or trade name,
device version or model,
labelled as single use,
packaged sterile,
need for sterilization before use,
quantity of devices provided in a package,
critical warnings or contra-indications: e.g. containing latex or DEHP.
any type of direct marking would interfere with the safety or performance of the device;
the device cannot be directly marked because it is not technologically feasible.
Implantable devices shall, at their lowest level of packaging (‘unit packs’), be identified, or marked using AIDC, with a UDI (UDI-DI + UDI-PI);
The UDI-PI shall have at least the following characteristics:
the serial number for active implantable devices,
the serial number or lot number for other implantable devices.
The UDI of the implantable device shall be identifiable prior to implantation.
Exemptions:
individual single-use disposable devices, the uses of which are generally known to the persons by whom they are intended to be used, which are contained within a system or procedure pack, and which are not intended for individual use outside the context of the system or procedure pack, shall not be required to bear their own UDI carrier;
devices that are exempted from bearing a UDI carrier on the relevant level of packaging shall not be required to bear a UDI carrier when included within a system or procedure pack.
The system or procedure pack UDI carrier shall as a general rule be affixed to the outside of the packaging.
The UDI carrier shall be readable, or, in the case of AIDC, scannable, whether placed on the outside of the packaging of the system or procedure pack or inside transparent packaging.
The UDI shall be assigned at the system level of the software. Only software which is commercially available on its own and software which constitutes a device in itself shall be subject to that requirement.
The software identification shall be considered to be the manufacturing control mechanism and shall be displayed in the UDI-PI.
the original performance;
the safety or the intended use of the software;
interpretation of data.
Such modifications include new or modified algorithms, database structures, operating platform, architecture or new user interfaces or new channels for interoperability.
Minor software revisions are generally associated with bug fixes, usability enhancements that are not for safety purposes, security patches or operating efficiency.
Minor software revisions shall be identified by a manufacturer-specific form of identification.
where the software is delivered on a physical medium, e.g. CD or DVD, each packaging level shall bear the human readable and AIDC representation of the complete UDI. The UDI that is applied to the physical medium containing the software and its packaging shall be identical to the UDI assigned to the system level software;
the UDI shall be provided on a readily accessible screen for the user in an easily-readable plain-text format, such as an ‘about’ file, or included on the start-up screen;
software lacking a user interface such as middleware for image conversion, shall be capable of transmitting the UDI through an application programming interface (API);
only the human readable portion of the UDI shall be required in electronic displays of the software. The marking of UDI using AIDC shall not be required in the electronic displays, such as ‘about’ menu, splash screen etc.;
the human readable format of the UDI for the software shall include the Application Identifiers (AI) for the standard used by the issuing entities, so as to assist the user in identifying the UDI and determining which standard is being used to create the UDI.
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