Regulatory Intelligence | June 2026
EUDAMED mandatory use begins, binding notified body timelines set, and MHRA launches UK framework consultation.
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
• EUDAMED's four core modules now mandatory: New devices must be registered before EU market placement
• IVDR Class C application deadline passed 26 May: Transitional window now closed for late applicants
• EU Implementing Regulation 2026/977 sets binding timelines for notified body conformity assessments
• MHRA publishes draft amendment regulations introducing UK international reliance pathways
• MHRA stakeholder consultation closes 19 June: GB market manufacturers should respond now
• FDA finalises human factors guidance for marketing submissions; soft implementation from 1 August
• TGA UDI mandatory for Class IIb and III devices from 1 July 2026
INTRODUCTION
We've been monitoring an unusually dense month across EU, UK, and international regulatory channels. The dominant theme is operational enforcement: several developments that have been anticipated for years; EUDAMED mandatory use chief among them; have now come into force, and the window for preparing is closed. For manufacturers that aren't yet compliant, the question is no longer what's coming; it's what to do this week.
RECENT DEVELOPMENTS - EU
EUDAMED’s Four Core Modules Are Now Mandatory
From 28 May 2026, use of four EUDAMED modules is legally required for all economic operators placing medical devices or IVDs on the EU market under MDR and IVDR. The four modules (Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance) shifted from voluntary participation to compulsory use following Commission Decision (EU) 2025/2371, which confirmed that the modules had reached full functional status and triggered the mandatory use provisions under Regulation (EU) 2024/1860.
In practice, this means any manufacturer without a Single Registration Number (SRN) cannot place new devices on the EU market from this date. New devices and IVDs must be registered in the UDI/Device module before first placement. For companies that treated EUDAMED registration as a background project, this is now an active compliance gap.
A separate deadline; for registration of existing, legacy device families already on the market, falls on 27 November 2026. Companies should audit their registration status now and prioritise accordingly.
»You can read the official news announcement here.
IVDR Class C Transitional Deadline Passed
Manufacturers of Class C in vitro diagnostic devices relying on the IVDR transitional provisions had until 26 May 2026 to submit a formal conformity assessment application to a notified body. This deadline is now passed. Manufacturers that did not submit by this date are no longer eligible for the extended transitional period and face a stricter compliance position. Those in this situation should seek regulatory advice promptly to assess their options under the IVDR.
»You can read the Transitional Provisions here.
Commission Implementing Regulation (EU) 2026/977: Binding Timelines for Notified Bodies
Published in the Official Journal on 5 May 2026, Commission Implementing Regulation (EU) 2026/977 introduces uniform quality management and procedural requirements for all notified bodies designated under MDR and IVDR. The regulation was adopted in response to persistent inconsistencies in how notified bodies interpreted Annex VII of both regulations, particularly around quotations, assessment timelines, and re-certification.
The key changes are binding maximum timelines: 30 days from receipt of a complete application to contract signature; 120 days from the start of the first audit activity to completion of the final review; 90 days for the final review of technical documentation; and 20 days from completion of final review to certificate issuance and registration in EUDAMED. Notified bodies will also be required to publish transparency reports comparing quoted costs and timelines against actuals. The regulation applies from 25 February 2027. Manufacturers preparing submissions or re-certifications in the coming year should engage their notified body now, with these timelines in view, to avoid scheduling gaps as the new rules come into effect.
»You can read the regulation here.
Updated EU Manufacturer Incident Report Template Now Mandatory
The updated Manufacturer Incident Report (MIR) template (version 7.3.1) became mandatory for all EU vigilance reporting from 1 May 2026. Manufacturers using older template versions in EUDAMED submissions should verify that their quality management systems and reporting processes have been updated accordingly.
»You can find the PMSV forms here.
RECENT DEVELOPMENTS - UK
MHRA Publishes Draft Medical Devices (Amendment) Regulations 2026
On 8 May 2026, the MHRA published the draft Medical Devices (Amendment) Regulations 2026, representing the most substantive proposed change to the UK medical device regulatory framework since Brexit. The regulations introduce three significant structural changes: an international reliance pathway designating Australia, Canada, and the USA as comparable regulator countries (CRCs), enabling manufacturers approved in those jurisdictions to access a streamlined route to GB market authorisation; a Predetermined Change Control Plan (PCCP) mechanism for software as a medical device, allowing planned software modifications to be implemented without full re-certification provided they fall within the approved plan; and strengthened requirements for custom-made devices, including full technical documentation and, for Class IIb and Class III implantable custom-made devices, a certified quality management system.
The MHRA has opened a stakeholder impact survey, which closes at 11:59pm on 19 June 2026. Manufacturers, importers, and authorised representatives with GB market interests should review the draft and respond. The amendment is expected to be adopted in December 2026 and come into force in June 2027.
»You can read the MHRAs news announcement here, and read the draft requirements on the World Trade Organisation’’s notification here.
RECENT DEVELOPMENTS - USA
FDA Finalises Human Factors Guidance for Marketing Submissions
The US FDA published a final guidance on 29 May 2026 - "Content of Human Factors Information in Medical Device Marketing Submissions," providing a risk-based framework for the human factors information that should be included in CDRH marketing submissions. The guidance applies to submissions to CDRH and clarifies what level of human factors documentation is expected at each stage. The FDA has noted a soft implementation date: for submissions received before 1 August 2026, it does not expect manufacturers to have fully incorporated the new recommendations. From 1 August 2026, new submissions should reflect the updated expectations. Manufacturers with US submissions in preparation should review the guidance and assess whether their human factors plans and documentation will meet the new standard.
You can read the notice here.
RECENT DEVELOPMENTS - Australia
Mandatory for Class IIb and Class III Devices: from 1 July 2026
From 1 July 2026, Unique Device Identification (UDI) becomes mandatory in Australia for higher-risk medical devices (Class IIb and Class III). This is part of the TGA's phased UDI implementation programme. Sponsors and manufacturers placing these device classes on the Australian market must ensure UDI labelling and registration requirements are met before that date.
You can read the TGAs guidance on the UDI requirements for medical devices here.
UPCOMING DEADLINES
The following confirmed deadlines fall within the next 90 days. Manufacturers, importers, and authorised representatives should verify their compliance status against each.
19 June 2026 - MHRA
Deadline for responses to the stakeholder impact survey on the draft Medical Devices (Amendment) Regulations 2026. GB market stakeholders should review the draft regulations and submit views before the survey closes at 11:59pm (UK time).
1 July 2026 - TGA
UDI labelling and AusUDID data submission requirements become mandatory for Class III and Class IIb medical devices.
1 July 2026 - Swissmedic
Mandatory registration of medical devices, IVDs and procedure packs in swissdamed begins (with a transition period running to 31 December 2026).
1 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.
Immediate Action Required - EU
EU MDR/IVDR: EUDAMED Actor Registration and UDI/Device registration are now mandatory. New devices cannot be placed on the EU market without prior registration.
27 Novemebr 2026 - EU
Legacy devices must be registered in the UDI/Device module of EUDAMED
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.
