A lot of information will have been produced in the previous steps. That information needs to be organised and presented in a way that demonstrates, if the device is approved; (a) it will conform to the EU’s technical requirements, (b) it will achieve its intended medical purpose and be safe to use, and (c) that proper processes were followed to generate the information which supports the approval.
Start by compiling a checklist of the “Technical Documentation” listed Annex II and Annex III. Most of the documentation listed will already have been generated during steps 1 to 4. However, a few additional items will be required to complete the documentation:
The "Unique Device Identifier" or UDI is one example of additional information which will be needed to complete the documentation. UDI is a barcode system that will enable devices to be tracked wherever they are distributed in the EU. The UDI system is described in Article 27 and Part C of Annex VI. Guidance is available.
Deliverables for demonstrating compliance:
(1) The Technical documentation,
(2) The Technical documentation on post-market surveillance.
Guidance
Guidance available from the Medical Device Coordination Group:
- MDCG 2022-7 Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU)
- MDCG 2021-19 Guidance note integration of the UDI within an organisation’s quality management system
- MDCG 2021-10 The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices
- MDCG 2021-09 MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers
- MDCG 2018-1 Rev. 4 Guidance on basic UDI-DI and changes to UDI-DI
- MDCG 2020-18 MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers
- MDCG 2019-2 Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017
- MDCG 2019-1 MDCG guiding principles for issuing entities rules on basic UDI-DI
- MDCG 2018-7 Provisional considerations regarding language issues associated with the UDI database
- MDCG 2018-6 Clarifications of UDI related responsibilities in relation to article 16
- MDCG 2018-5 UDI assignment to medical device software
- MDCG 2018-4 Definitions/descriptions and formats of the UDI core elements for systems or procedure packs October 2018
- MDCG 2018-3 Rev.1 Guidance on UDI for systems and procedure packs.
Where can I find the regulations for IVDR?
http://www.euivdr.com
Hi,
Thank you fo a GREART step by step instr.
I have a question reqarding the “Unique Device Identifier” or UDI. If a software is denifed as a Medical device dose it need a UDI nr? What part of the software should have the UDI the plattform or the modules? Keeping in mind we do tailored software to clients.
Thank you!
Thank you for your question about UDI requirements for software devices.
Every medical device requires a UDI, including software devices. However, the EU MDR doesn’t go into such detailed specifics. You are recommended to consult current IMDRF guidance, for example the 2019 guidance document “Principles of labelling medical devices and IVD devices” which has guidance for software devices.
Article 27(7) states “As part of the technical documentation referenced to in Annex II, the manufacturer shall keep up to date a list of all UDIs that it has assigned” However, Annex II only references documenting the Basic UDI-DI (1.1b). Does this fulfill the requirement for Article 27(7), or is it expected that all full UDIs (UDI-DI + UDI-PI) will be listed in technical documentation?
Thank you for your question UDIs listed in the technical documentation.
The Basic UDI-DI or BUDI-DI referred to in 1.1b is not a unique device identifier but the global model number or equivalent. If that is not clear, please consult your UDI code-issuing entity.
Prior to the conformity assessment and production start, there will exist presumably only a list of planned variants, together with their respective (planned) UDI-DIs. After conformity assessment and production start, there will exist presumably the production records, including the list of actual UDI-PIs.
Good day
Should Annex II be seen as the structure for a technical file, or is it only indicative of the components that shall be included in the technical file and the manufacturer can decide the actual structure of the technical file?
Thank you for your question about the technical documentation:
Annexes II and III do not specify the structure or format of the technical documentation, as is the case for example with the (medicines) eCTD. Annex II and Annex III specify only that the technical documentation “shall include in particular the elements listed in this Annex.” What is required however is that the technical documentation “be presented in a clear, organised, readily searchable and unambiguous manner.”
Dear All
Will MDR QMS replace ISO 13485 certificate ?
Thank you for your question.
Under the MDD, Notified Bodies issue a certificate that confirms the quality management system of the manufacturer satisfies the requirements of Annex II of Directive 93/42/EEC. Under the EU MDR, Notified Bodies issue an EU quality management system certificate according to Annex IX of Regulation (EU) 2017/745. Historically, most manufacturers have requested an additional ISO 13485 certificate, but it is not required for the EU.