Skip to content
Medical Device Regulation

Get Support about new MDR

  • Solve your doubts
Medical Device Regulation

Get Support about new MDR

  • Download MDR
  • Free MDR Gap Analysis
    • MDR Transition Plan
  • MDD/MDR Resources
    • MDR Designated Notified Body
    • MDR NANDO Status Check
    • MDR Guidance Documents
    • MEDDEV Guidance List – Download
    • MDR Corrigendum
    • UDI / EUDAMED Guidance
    • MDCG endorsed documents
    • Harmonized Standards List
  • MDR Support
    • MDR Trainings
  • Contact us
    • Free Call with our MDR Experts
    • SWISS / EU AR / UK REP Free Call
    • Disclaimer and Cookie Policy (EU)
  • Search for:

Tag Archives: Part 2

  • Home   /  
  • Posts tagged "Part 2"
MassimoP Z - Annex (6) VI - PART C - The UDI system (PART 2) and the UDI system, annex, ANNEX VI, 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, mdr, Part 2, UDI, UDI system

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 C

The UDI system (PART 2)

5.9. Internationally-accepted standards for data submission and updates shall, wherever possible, be used by the UDI database.

5.10. The user interface of the UDI database shall be available in all official languages of the Union. The use of free- text fields shall, however, be minimized in order to reduce translations.

5.11. Data relating to devices that are no longer available on the market shall be retained in the UDI database.

6. Rules for specific device types

6.1. Implantable devices:

6.1.1. Implantable devices shall, at their lowest level of packaging (‘unit packs’), be identified, or marked using AIDC, with a UDI (UDI-DI + UDI-PI);

6.1.2. The UDI-PI shall have at least the following characteristics:

(a)the serial number for active implantable devices,
(b)the serial number or lot number for other implantable devices.

6.1.3. The UDI of the implantable device shall be identifiable prior to implantation.

6.2. Reusable devices requiring cleaning, disinfection, sterilisation or refurbishing between uses

6.2.1. The UDI of such devices shall be placed on the device and be readable after each procedure to make the device ready for the next use.

6.2.2. The UDI-PI characteristics such as the lot or serial number shall be defined by the manufacturer.

6.3. Systems and procedure packs as referred to in Article 22

6.3.1. The natural or legal person referred to in Article 22 shall be responsible for identifying the system or procedure pack with a UDI including both UDI-DI and UDI-PI.

6.3.2. Device contents of system or procedure packs shall bear a UDI carrier on their packaging or on the device itself.

Exemptions:

(a)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;
(b)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.

6.3.3. Placement of the UDI carrier on systems or procedure packs

(a)The system or procedure pack UDI carrier shall as a general rule be
affixed to the outside of the packaging.
(b)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.

6.4. Configurable devices:

6.4.1. A UDI shall be assigned to the configurable device in its entirety and shall be called the configurable device UDI.

6.4.2. The configurable device UDI-DI shall be assigned to groups of configurations, not per configuration within the group. A group of configurations is defined as the collection of possible configurations for a given device as described in the technical documentation.

6.4.3. A configurable device UDI-PI shall be assigned to each individual configurable device.

6.4.4. The carrier of the configurable device UDI shall be placed on the assembly that is most unlikely to be exchanged during the lifetime of the system and shall be identified as the configurable device UDI.

6.4.5. Each component that is considered a device and is commercially available on its own shall be assigned a separate UDI.

6.5. Device Software

6.5.1. UDI assignment Criteria

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.

6.5.2. A new UDI-DI shall be required whenever there is a modification that changes:

(a)the original performance;
(b)the safety or the intended use of the software;
(c)interpretation of data.

Such modifications include new or modified algorithms, database structures, operating platform, architecture or new user interfaces or new channels for interoperability.

6.5.3. Minor software revisions shall require a new UDI-PI and not a new UDI-DI.

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.

6.5.4. Minor software revisions shall be identified by a manufacturer-specific form of identification.

(a)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;
(b)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;
(c)software lacking a user interface such as middleware for image
conversion, shall be capable of transmitting the UDI through an
application programming interface (API);
(d)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.;
(e)the human readable format of the UDI for the software shall includethe 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.

EU AR, PRRC, Swiss AR

Reach out in case you need support

    Please prove you are human by selecting the Plane.

    Search through MDR

    UKCA – UK Resp. Person

    Reach out to UKCA experts team

      Please prove you are human by selecting the Star.

      Navigate MDR

      UDI EUDAMED TOOL

      We offer an easy and low-cost software solution to manage UDI and communicate with EUDAMED. Try it now for free!

         

         

         

        MDR Guidance and Tools

        • MDR NANDO Check
        • Free MDR Gap Analysis
        • MDCG endorsed documents
        • Harmonized Standards List
        • Book a Free Call with our MDR Experts
        • MDR Guidance Documents
        • MEDDEV Guidance List – Download
        • UDI/EUDAMED Documents

        Newsletter

        Tags

        amendement and the UDI system annex ANNEX I ANNEX I - General Safety and performance requirements ANNEX VI assessment assessment procedure authorities CE CE marking certificate Chapter I Chapter II Chapter III clinical clinical evaluation clinical investigation clinical investigations conformity conformity assessment core data elements to be provided to the UDI database together with the UDI-DI in accordance with articles 28 and 29 designation electronic electronic system evaluation general requirements general safety General Safety and performance requirements importers market mdr notified bodies performance requirements post-market post-market surveillance procedure registration requirements review safety technical documentation UDI UDI database UDI system

        Navigate MDR

        Signup

        Search through MDR

        • Download MDR
        • Free MDR Gap Analysis
          • MDR Transition Plan
        • MDD/MDR Resources
          • MDR Designated Notified Body
          • MDR NANDO Status Check
          • MDR Guidance Documents
          • MEDDEV Guidance List – Download
          • MDR Corrigendum
          • UDI / EUDAMED Guidance
          • MDCG endorsed documents
          • Harmonized Standards List
        • MDR Support
          • MDR Trainings
        • Contact us
          • Free Call with our MDR Experts
          • SWISS / EU AR / UK REP Free Call
          • Disclaimer and Cookie Policy (EU)

        Powered by TS Q&E - ISO 13485:2016 Medical Device Consulting Services

        Manage Cookie Consent
        We use cookies to optimise our website and our service.
        Functional Always active
        The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.
        Preferences
        The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.
        Statistics
        The technical storage or access that is used exclusively for statistical purposes. The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you.
        Marketing
        The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes.
        Manage options Manage services Manage vendors Read more about these purposes
        View preferences
        {title} {title} {title}