Update to MDCG UDI Guidance & Minutes from the recent MDCG meetings released!

Guidance on BASIC UDI-DI and changes to UDI-DI

The new revision of the MDCG guidance on the Unique Device Identification (UDI) system for medical devices has been released. This version deletes the word ‘group’ of paragraph 3 of The Basic UDI-DI section and adds a third point regarding Maximum number of Reuses in the section of Changes of UDI-DI.

Below an extract of the modified sections of the MDCG Guidance on BASIC UDI-DI and changes to UDI-DI:

The Basic UDI-DI

Any Basic UDI-DI shall identify the devices covered by the BASIC UDI-DI in a unique manner.

Changes of UDI-DI

3. Maximum number of Reuses

Annex VI Part B, 17 states that the manufacturer shall provide to the UDI database the maximum number of reuses of the device concerned, if applicable.

‘If applicable’ should be understood to cover those devices where based on clinical evidence and as a result of the risk management process, a manufacturer has demonstrated a maximum number of reuses, which should not be surpassed. This may include but is not limited to devices for which there is evidence of degradation or deterioration beyond a certain number of re-uses.

Whilst the maximum number of re-uses depends on multiple factors such as the material, the user and relevant process changes, examples of devices where this requirement could apply include:

  • Minimally-invasive robotic instruments,
  • Larynx masks,
  • Surgical instruments : scalpels, curettes, clamps, drills, burs,
  • Endoscopic devices: biopsy forceps, polyp retrieval basket.

Without prejudice to ‘if applicable’, it is noted that the MDR generally does not require a maximum number of re-uses for re-usable devices.

If a maximum number of re-uses is established and claimed by the manufacturer, this number shall be provided to the UDI Database in EUDAMED and in addition, reflected in the instructions for use in accordance with Annex I, GSPR 23.4 (n).

For such products whose maximum number of re-uses is determined, a change to this data element will require the allocation of a new UDI-DI.

Minutes from the recent MDCG meetings

The new minutes of the meeting of the Medical Devices Coordination Group (MDCG) with stakeholders the 4th of April and the meetings of the MDCG both the 4th and the 5th of April have been published. From them, there are multiple discussed points that are worth to mention, starting with concerns expressed by stakeholders regarding the fast-approaching IVDR date of application with only 4 Notified Bodies being designated, lack of guidance documents and harmonized approaches when it comes to remote audits.

Common specifications for COVID-19 tests under IVDR –for information

Draft CS covering RT-PCR, antigen and antibody tests have been developed and it is planned to make the specifications available as guidance while the adoption process is ongoing.

Borderline & Classification

Guidance on borderline with medicines estimated to be finalised by May 2021.

Guidance on classification of medical devices to be finalised also by May 2021.

Market   surveillance:

Guidance under development   on   economic   operators   including   on authorised representatives, a Q&A on Importers & Distributors, Art.16 re-packaging & re-labelling activities.


PSUR (Periodic Safety Update Report) guidance is planned to be adopted by beginning of May.

Nomenclature – EMDN

The first official version of the EMDN (European Medical Device Nomenclature) in Italian is now available Most importantly, a first draft in English is currently under elaboration and is expected for publication prior to the date of application. As for the other EU languages, they will be rolled out as soon as they have been finalised and validated. 

Work is currently also ongoing with authorities on the elaboration of guidance regarding the allocation of EMDN codes to individual UDI-DI and on setting up the governance structure.

In addition, work is currently ongoing on the harmonisation of terms to identify devices on the implant card.

Customs agreement with Turkey

Moreover, regarding the ongoing negotiations with Turkey, it has been informed that the technical assessment of Turkish legislation has been completed and agreement is expected to be signed soon.

Possible update of MRA with Switzerland

In addition, discussions between the EU and Switzerland are currently ongoing at highest level. Despite this, stakeholders were asked to be prepared for a situation of no update prior to the date of application of MDR (26 May 2021)

You can find full text of Minutes here: Meeting of the Medical Devices Coordination Group1(MDCG)with stakeholders 4/3/2021 & Meeting of the Medical Devices Coordination Group1(MDCG)4/3/2021and 5/3/2021 and in our Library of Documents (MDCG).

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