The week of 15–21 June 2026 brought several relevant regulatory updates in the medical device and in vitro diagnostic (IVD) sectors. The main developments included new references to harmonised standards under the MDR and IVDR, two MDCG publications concerning the management of SS(C)Ps in EUDAMED and the transition to the “EU REP” symbol, and two FDA classification orders covering machine learning-based imaging software and an ingestible gastrointestinal diagnostic device.
European Commission Updates Harmonised Standards References under the MDR and IVDR
On 17 June 2026, the European Commission published two implementing decisions updating the references to harmonised standards under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
Commission Implementing Decision (EU) 2026/1231 updates the list of harmonised standards under the MDR across several technical areas.
Commission Implementing Decision (EU) 2026/1313 adds EN ISO 15223-1:2021/A1:2025 to the list of harmonised standards under the IVDR. The amendment includes the introduction of the “EU REP” symbol for authorised representatives established in the European Union.
The updated references may support a presumption of conformity with the MDR and IVDR requirements covered by the relevant standards.
Source: European Commission / Official Journal of the European Union
Reference: Commission Implementing Decisions (UE) 2026/1231 and (UE) 2026/1313
MDCG Publishes Transitional Arrangements for Managing SS(C)P in EUDAMED
The Medical Device Coordination Group published MDCG 2026-4, addressing the management of Summaries of Safety and Clinical Performance and Summaries of Safety and Performance in EUDAMED following the start of mandatory use.
Under the transitional arrangements, notified bodies remain responsible for uploading the master SSCP and SSP documents until new functionality becomes available for manufacturers.
According to the document, the new manufacturer functionality is planned for release in the EUDAMED Playground environment in July 2026 and in the Production environment in October 2026.
The position paper clarifies how responsibilities for managing these documents are expected to shift from notified bodies to manufacturers during the transition.
Source: Medical Device Coordination Group
Reference: MDCG 2026-4 — Management of SS(C)P in EUDAMED after mandatory use
MDCG Provides Guidance on the Transition to the “EU REP” Symbol
The MDCG published an appendix to MDCG 2021-5 Rev. 1 addressing the transition from the “EC REP” symbol to the new “EU REP” symbol introduced by EN ISO 15223-1:2021/A1:2025.
The change is described as editorial and does not affect the responsibilities or legal status of the authorised representative.
According to the appendix, the previous and amended versions of the standard will coexist until 17 June 2031.
The five-year transition period allows manufacturers to plan updates to labels and related materials without requiring their immediate replacement solely because of the symbol change.
Source: Medical Device Coordination Group
Reference: MDCG 2021-5 Rev. 1 — Appendix on the transition to the “EU REP” symbol
FDA Classifies Machine Learning-Based Imaging Software with a PCCP into Class II
The U.S. Food and Drug Administration classified radiological machine learning-based quantitative imaging software with a Predetermined Change Control Plan into class II with special controls.
Special controls address development and validation data, performance testing, software verification and validation, risk management, planned modifications under the PCCP and labelling requirements. The final order became effective on 17 June 2026.
The classification establishes a codified class II regulatory framework for radiological imaging software designed to undergo predefined modifications under an authorised Predetermined Change Control Plan.
Source: FDA / Federal Register
Reference: Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan
FDA Classifies Ingestible Gastrointestinal Blood Detection Capsules into Class II
FDA classified prescription ingestible capsules that use spectrophotometry to detect blood in the gastrointestinal tract into class II with special controls.
Special controls cover biocompatibility, clinical and non-clinical performance testing, software verification and validation, electromagnetic compatibility and labelling. The final order became effective on 17 June 2026.
The classification creates a defined class II regulatory framework for this category of ingestible gastrointestinal diagnostic devices.
Source: FDA / Federal Register
Reference: Classification of the Ingestible Gastrointestinal Blood Detection Capsule
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