MDCG update, past 6 months
Jouni Karkinen
8/7/20263 min read
MDCG update from the last 6 months
The Medical Device Coordination Group (MDCG) has published or revised several documents affecting medical device and IVD manufacturers.
1. UDI remains the manufacturer's responsibility
MDCG 2026-5 Position Paper: UDI assignment between manufacturers and distributors
MDCG has clarified an important point concerning private-label and distributor arrangements: the manufacturer is the only economic operator that can assign the UDI to a device.
The manufacturer is also responsible for registering the device in EUDAMED.
This is directly relevant to MDR Class I and IVDR Class A manufacturers.
What should manufacturers do?
Review any arrangements where distributors, private-label partners or other parties manage UDI information. Make sure that UDI assignment, issuing-entity accounts and EUDAMED registrations correctly identify the legal manufacturer.
2. Check your medical device classification
MDCG 2021-24 Rev.1: Guidance on classification of medical devices
The new revision includes updates and clarifications concerning several classification rules, including Rules 2, 8, 9, 10, 12, 16 and 22, as well as terminology concerning invasiveness.
This is particularly important for Class I manufacturers because they normally determine and document their own classification without a notified body checking it before market access.
What should manufacturers do?
Review the classification rationale in the technical documentation against the revised guidance.
Medical-device software manufacturers should also keep the guidance in their classification file, although Rule 11 itself was not one of the rules specifically revised in this update.
This guidance concerns MDR medical devices rather than IVDR classification.
3. EMDN has been updated, check your device codes
Several related EMDN documents were published or revised in April 2026:
MDCG 2026-1: Summary of EMDN 2025 Submissions and outcome of annual revision
MDCG 2026-2: 2025–2026 Annual Revision Change Log
MDCG 2026-3: 2026 EMDN Version History
MDCG 2021-12 Rev.2: FAQ on the European Medical Device Nomenclature (EMDN)
EMDN is used when devices are registered in EUDAMED, including Class I medical devices and Class A IVDs. The revised FAQ stresses that manufacturers should select the most granular applicable terminal EMDN code. Obsolete codes cannot be used for new registrations or updates.
This has become particularly relevant now that use of the EUDAMED UDI/Device module is mandatory from 28 May 2026.
What should manufacturers do?
Check that the EMDN code assigned to each device still corresponds to the current 2026 nomenclature before creating or updating EUDAMED records.
4. “EC REP” is becoming “EU REP”
MDCG 2021-5 Rev.1 Appendix: Transition to the “EU REP” symbol
EN ISO 15223-1 has introduced the EU REP symbol to replace the familiar EC REP symbol for authorised representatives.
This is an editorial change without an impact on device safety or performance. Manufacturers do not need to make an immediate label change. The transition period allows continued use of the existing EC REP symbol until 17 June 2031.
This affects also Class I and Class A devices manufactured outside the EU where an EU authorised representative is required.
What should manufacturers do?
There is no need for emergency relabelling. Add the change to the normal label and artwork update programme and plan the transition to EU REP well before June 2031.
5. A specific Class I UDI change for optical devices
MDCG 2025-8 Rev.1: Guidance on implementation of Master UDI-DI for spectacle frames, spectacle lenses and ready-to-wear reading spectacles
This guidance concerns individualised spectacle frames, spectacle lenses and ready-to-wear reading spectacles.
The Master UDI-DI labelling requirements become mandatory on 1 November 2028. Devices manufactured before that date do not need the Master UDI-DI on their label.
What should affected manufacturers do?
Start planning the Master UDI-DI structure, issuing-entity arrangements, EUDAMED data and future label changes well before the 2028 deadline.
6. SSCP and SSP management is moving towards manufacturers
MDCG 2026-4: Position Paper: Management of SS(C)P in EUDAMED after mandatory use
The document describes changes to how Summaries of Safety and Clinical Performance (SSCP) and Summaries of Safety and Performance (SSP) will be managed in EUDAMED. Manufacturers will take a greater role in uploading the documents and their translations.
MDR Class I / IVDR Class A: Not relevant.
SSCP requirements concern implantable and Class III medical devices, while SSP requirements concern Class C and D IVDs.
7. Article 10a, supply interruptions and discontinuations
Q&A Rev.2 on Article 10a and the new Article 10a Decision Tree
Updated guidance helps manufacturers determine when an interruption or discontinuation of device supply must be notified under Article 10a MDR/IVDR.
Importantly, Article 10a is not limited to higher-risk devices. Except for custom-made devices, it may apply to any MDR or IVDR device, including MDR Class I and IVDR Class A devices, where interruption or discontinuation of supply could foreseeably result in serious harm or a risk of serious harm to patients or public health.
Where Article 10a applies, the manufacturer must normally inform the relevant competent authority and directly supplied economic operators, health institutions or healthcare professionals at least six months before the anticipated interruption or discontinuation. In exceptional circumstances, notification must be made without undue delay.
What should manufacturers do?
Add Article 10a to the company’s supply-chain and product-discontinuation procedures. Define who evaluates the potential patient or public-health impact, who triggers the notification process and how the six-month notification requirement is monitored.
Summary
Check your classification rationale.
Check your UDI responsibilities.
Check your EMDN codes and EUDAMED data.
For non-EU manufacturers, include the EU REP symbol transition in your labelling plan.
Check your Article 10a oblications.
Contact for more information!
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