Regulatory Intelligence | July 2026

EU AI Act Omnibus formally adopted, new harmonised standards reshape MDR/IVDR labelling, and MDCG clarifies EUDAMED responsibilities for manufacturers, and MHRA expands AI regulatory sandbox.

Prepared by SciMed Consultancy Ltd for regulatory, legal, quality, and market-access teams operating under EU MDR, IVDR, UK MDR, and related global frameworks.

THIS MONTH IN BRIEF

• EU AI Act Omnibus formally adopted: High-risk AI obligations for MDR/IVDR-regulated devices extended to 2 August 2028

• Standalone Annex III high-risk AI systems postponed to 2 December 2027

• MDCG 2026-4: Manufacturers now responsible for SS(C)P and SSP uploads in EUDAMED

• Notified bodies retain validation confirmation role

• Implementing Decisions 2026/1231 and 2026/1313 have updated and expanded the list of harmonised standard supporting MDR & IVDR

• EN ISO 15223-1 amendment introduces "EU REP" symbol, 5-year coexistence period applies, with accompanying MDCG Guidance on EU REP symbol transition published

• MHRA expands AI regulatory sandbox to cover medical devices

• Health Canada MDEL import rules amended — supplier information requirements updated

INTRODUCTION

July's regulatory output was shaped by two parallel threads: the finalisation of long-anticipated EU process changes and a quiet but significant shift in how responsibilities are distributed between manufacturers and notified bodies.

The AI Act Omnibus, formally adopted on 29 June, settles the compliance timeline for AI-enabled medical devices and gives manufacturers a confirmed 2028 horizon, but not a reason to pause.

On the process side, the combination of new MDCG positions on EUDAMED responsibilities, updated harmonised standards, and clearer PMS/PMCF expectations signals that the post-mandatory-EUDAMED era comes with a more demanding administrative baseline than many manufacturers may have anticipated.

RECENT DEVELOPMENTS - EU

AI Act Omnibus Formally Adopted: MedTech Deadline Extended to August 2028

The European Parliament formally endorsed the AI Act simplification package on 16 June 2026. The Council of the EU gave its final approval on 29 June, completing the legislative process. The regulation enters into force three days after publication in the Official Journal, which is expected imminently.

For medical device and IVD manufacturers, the key change is a 12-month extension for AI systems embedded in products regulated under EU product safety legislation, including devices regulated under MDR and IVDR. These Annex I high-risk AI systems now have until 2 August 2028 to comply with full high-risk obligations, extended from the original 2 August 2027 deadline. A separate 16-month postponement covers standalone high-risk AI systems listed in Annex III (systems not embedded in an MDR/IVDR-regulated product) shifting their deadline from 2 August 2026 to 2 December 2027.

The extension was driven by the slow pace of harmonised standards development; many of the technical standards needed to operationalise compliance were still being drafted. Manufacturers of AI-enabled devices should use the additional time to complete AI risk management documentation, map AI Act requirements against existing MDR/IVDR technical files, and assess whether QMS data governance and logging obligations require structural changes. The 2028 date is now firm; a last-minute compliance sprint in 2027 will be considerably more disruptive than starting the gap assessment now.

»You can read the EU AI Act Omnibus here.

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MDCG 2026-4: Manufacturers Now Responsible for SS(C)P and SSP Uploads in EUDAMED

Published on 17 June 2026, MDCG 2026-4 is a position paper addressing the management of Summaries of Safety and Clinical Performance (SSCPs, for relevant MDR devices) and Summaries of Safety and Performance (SSPs, for IVDR Class C and D devices) in EUDAMED following the system's mandatory use from 28 May.

The practical change is significant: manufacturers are now responsible for uploading both the validated master version of the SSCP or SSP and all required language translations, in accordance with Article 29(4) MDR. Notified bodies retain the role of confirming which documents they validated, using EUDAMED's updated functionality to link validated documents to the relevant certificate and Basic UDI-DI. The responsibility for ensuring the uploaded document matches the notified body-validated version sits entirely with the manufacturer.

Manufacturers who have not yet uploaded SSCPs or SSPs should treat this as a priority. Any outstanding language translations should also be addressed promptly.

»You can read the Guidance Document here.

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Updated & Expanded Harmonised Standards Under MDR & IVDR: Including the EU REP Symbol

Two Commission Implementing Decisions, (2026/1231 for MDR and 2026/1313 for IVDR) were published in the Official Journal in June 2026, updating the list of harmonised standards under both regulations. The most immediately visible change for most manufacturers is the harmonisation of EN ISO 15223-1:2021/A1:2025, which introduces a new graphical symbol for authorised representatives: "EU REP" now replacing "EC REP."

A 5-year coexistence period applies: both symbols may be used until 17 June 2031, after which only "EU REP" will be acceptable. Manufacturers should plan label artwork updates as part of their next scheduled revision cycle. The two Implementing Decisions also cover updated standards across biological evaluation, electrical equipment safety, and other technical areas. A review of which updated standards apply to each device portfolio is warranted, with any necessary updates reflected in technical documentation.

An accompanying appendix to MDCG 2021-5 Rev.1, also published on 17 June 2026, provides practical guidance on managing the EC REP to EU REP transition for both manufacturers and their EU authorised representatives.

»You can read the two implementing decisions here (MDR) and here (IVDR) plus MDCG 2021-5 Rev 1 Appendix here.

RECENT DEVELOPMENTS - UK

MHRA Expands AI Regulatory Sandbox to Cover Medical Devices

June 2026 saw the MHRA announced an expansion of its AI sandbox model across both medicines and medical devices. Two initiatives launched in quick succession: a UK-wide regulatory sandbox for testing AI-driven approaches to product safety and behaviour, and London Region I, a new sandbox delivered in partnership with NHS England and the London Health Innovation Networks.

Whilst neither initiative creates new compliance obligations, they do, however, signal that the MHRA is actively building the infrastructure to engage with AI-enabled medical devices earlier in the development cycle, before formal market authorisation. 

For manufacturers developing SaMD or AI-augmented devices for the GB market, participation in or awareness of these sandboxes could offer early regulatory dialogue that informs both product design and the eventual submission strategy. The MHRA has indicated it will publish further details on eligibility and application processes in due course.

»You can read the MHRAs press release here.

RECENT DEVELOPMENTS - Canada

Medical Device Establishment Licence Import Rules Amended

The Regulations Amending the Medical Devices Regulations (Establishment Licences) entered force on 4 June 2026, published in the Canada Gazette (Part 2, Volume 160, Number 12). The amendment removes the requirement for Canadian importers holding a Medical Device Establishment Licence (MDEL) to import exclusively from foreign distributors that themselves hold an MDEL. All MDEL applicants must now provide full supplier information at the point of application and update it annually at licence review.

The change reduces administrative friction for importers sourcing from foreign distributors without a Canadian MDEL; a common situation that created burden without a clear safety benefit, since a licensed Canadian importer provides adequate traceability. Manufacturers supplying the Canadian market through importers should confirm their importer's MDEL reflects the updated supplier information requirements.

»You can read the Canada Gazette entry here.

UPCOMING DEADLINES

The following confirmed deadlines fall will be upon us soon. Manufacturers, importers, and authorised representatives should verify their compliance status against each.

• 1st July 2026 - Swissmedic

  • Mandatory registration of medical devices, IVDs and procedure packs in swissdamed begins (with a transition period running to 31 December 2026).

• 2nd July 2026 - TGA

  • UDI labelling and AusUDID data submission requirements become mandatory for Class III and Class IIb medical devices.

• 19th July 2026 - EU

  • WET Delegated Regulations C(2026) 1798 and C(2026) 1809 enter into force (20 days after 29 June OJ publication). Manufacturers of newly listed WET devices should assess impact on clinical evaluation and conformity assessment strategy.

• 1st August 2026 - FDA

  • UDI labelling and AusUDID data submission requirements become mandatory for Class III and Class IIb medical devices. Soft implementation date for the new Human Factors guidance on marketing submissions. Submissions received from this date are expected to reflect the updated human factors documentation requirements in the May 2026 final guidance.

• 2nd August 2026 - EU AI Act

  • Obligations under Articles 5 (prohibited AI practices) and 4 (AI literacy) remain in effect. Note: high-risk obligations for Annex III systems originally due on this date have been postponed to 2 December 2027 under the Omnibus. MDR/IVDR-embedded AI systems have until 2 August 2028.

• 27th Novemebr 2026 - EU

  • Legacy devices must be registered in the UDI/Device module of EUDAMED

• 2nd December 2027 - EU AI Act

  • Forward Planning

    Full high-risk obligations apply to standalone Annex III AI systems. Gap assessments should begin now.

• 2nd August 2028 - EU AI Act

  • Forward Planning

    Full high-risk obligations apply to AI systems embedded in MDR/IVDR-regulated products.

Need help interpreting how these changes affect your organisation?

Regulatory changes rarely affect products in isolation. Classification strategy, evidence planning, market access, software change control, supply continuity, and lifecycle obligations increasingly overlap across jurisdictions.

If your team is assessing the operational or commercial implications of any of the developments above, we can help pressure-test the impact against your specific products, portfolio, or regulatory strategy.