Brought to you by our Head of Regulatory Richie Christian, our June 2026 MedTech news roundup covers the latest on EUDAMED, the proposed updates to MDR and IVDR, the recent amendment to the Annex to Implementing Decision (EU) 2021/1182, and MDCG guidance on the transition to the EU REP symbol.

New options in swissdamed, findings from the MHRA’s National Commission into AI regulation in healthcare, and FDA guidance on human factors content in marketing submissions and premarket notification requirements exemptions respectively also feature, as well as the NMPA’s draft guidelines on clinical activities. Read on for more…

MedTech news from the EU, Switzerland & UK

First four EUDAMED modules now mandatory

As of 28 May 2026, the first four modules of EUDAMED became mandatory.

The four modules span Actor registration, UDI/Device registration, Notified Bodies & Certificates, and Market Surveillance – the latter for Competent Authorities and the EU Commission.

The remaining two interconnected modules – Clinical Investigations and Performance Studies and Vigilance and Post-market Surveillance are under analysis and in development respectively. Read more about EUDAMED here.

MDCG publishes position on management of SSCP in EUDAMED

The MDCG has published a position paper on the management of SS(C)P in EUDAMED after mandatory use.

Within the paper (MDCG 2026-4), the policy of uploading the master Summary of Safety and Clinical Performance (SSCP) and the Summary of Safety and Performance (SSP) is evolving such that this activity will now be performed by the manufacturer instead of the notified body. This procedure also applies to SSPs for IVDs. Read the full paper here.

Council of the EU shares progress report on simplification of MDR & IVDR

In December last year, the EU Commission proposed amendments to the existing EU MDR and IVDR. Since then, Member States have been conducting detailed article-by-article discussions.

Whilst the Member States broadly support the goals of the proposal overall, many issues around governance, oversight, SME support, AI regulation, and the balance between simplification and patient safety remain under negotiation. Read the progress report here.

Team-NB expresses concern on expansion of WET devices under MDR

As reported in our April roundup, on 20 March this year the EU Commission published two implementing regulations (C(2026) 1798 and C(2026) 1809) to expand the list of Well-Established Technologies (WET) under the EU MDR.

This month, Team-NB, together with several stakeholders, has published a joint statement expressing concerns regarding the potential for increased patient risk, inconsistent interpretations by manufacturers, and disputes between notified bodies and manufacturers. Read the full statement here.

Team-NB considers proposed discount for micro and small enterprises problematic

Team-NB has this month published a position paper on the proposed 50% discount on conformity assessment fees for micro and small enterprises under the MDR and IVDR revision.

Team-NB considers this problematic, as in their view, this neither accounts for the practical realities of conformity assessment activities nor the financial constraints under which notified bodies operate. Instead of fee reductions for micro and small enterprises, Team-NB’s paper outlines several alternative solutions to support these companies. Read the paper here.

EU Commission amends harmonised standards

On 17 June, Commission Implementing Decision (EU) 2026/1231 amending Implementing Decision (EU) 2021/1182 regarding harmonised standards was published in the Official Journal of the European Union.

The Annex to Implementing Decision (EU) 2021/1182 has been amended in accordance with the Annex for standards in biological evaluation of medical devices, symbols to be used with information to be supplied by the manufacturer, medical electrical equipment, transfusion equipment for medical use, ophthalmic optics, non-active surgical implants, washer-disinfectors, prosthetics, and sharps injury protection. Find out more about the amendment here.

MDCG shares guidance on transition to EU REP symbol

This month, the MDCG shared its guidance on the transition to the ‘EU REP’ symbol in EN ISO 15223-1.

The harmonised standard EN ISO 15223-1:2021 as amended by EN ISO 15223-1:2021/A1:2025 includes a specific symbol for the authorised representative in the Union as ‘EU REP’ instead of ‘EC REP’.

This MDCG guidance recognises the change being editorial in nature – and not requiring prior approval from a notified body. Additionally, a transition period of five years until 17 June 2031 has been granted, ensuring sufficient time to adapt processes and labelling. Importantly, both the ‘EC REP’ and ‘EU REP’ symbols may be used on different levels of packaging during the transition period. Read the guidance here.

New options now available for registering devices in swissdamed

As of this month, swissdamed now includes new options for device registration.

A new online editor that provides an uncomplicated and intuitive option for entering devices, systems, and procedure packs directly in the system features, as well as a Machine-to-Machine (M2M) interface and Master UDI-DI registration.

Collectively, these improvements allow simple manual data entry and automated data exchange for larger volumes. Find out more here.

MHRA publishes findings from National Commission into AI regulation in healthcare

The UK’s MHRA has published two reports that summarise the findings from the National Commission into the Regulation of AI in Healthcare’s call for evidence and wider research and engagement activities.

The reports offer a clear explanation of the data collected and the major topics that emerged from this study, including viewpoints on the advantages, dangers, and real-world difficulties related to AI in healthcare and how these might influence future regulations for AI-enabled technology. Read more on the findings here.

MedTech news from the US & China

FDA publishes final guidance on human factors content in medical device marketing submissions

The FDA has finalised the December 2022 draft guidance on the content of human factors information in medical device marketing submissions – releasing its final guidance at the end of last month.

The final guidance outlines the FDA’s expectation to receive human factors information in a marketing submission based on the Submission Category. This latest guidance, which describes what information should be submitted to the FDA as part of the market submission, should be applied in conjunction with the February 2016 guidance document which defines how human factors and usability engineering should be applied during medical device development. Read the final guidance here.

FDA outlines intent for premarket notification requirements exemptions

On 4 June, the FDA published a new guidance document on its intent to exempt certain unclassified medical devices from 510(k) premarket notification requirements.

Specific product codes for ear, nose, and throat; gastroenterology-urology; general and plastic surgical; obstetrical and gynaecological; physical medicine; neurological; toxicology; and ophthalmic are included. Access the final guidance here.

NMPA shares draft guidelines on clinical evaluation and trials

This month, China’s NMPA drafted three guidelines, which are now open for public comment until 10 July. The three guidelines include:

• Guidelines for Clinical Evaluation Registration Review of AI-Assisted Diagnostic Medical Devices
• Guidelines for Clinical Evaluation of Registration Review of Joint Replacement Surgical Navigation and Positioning Systems for the Same Product, and
• Clinical Trial Guidelines for Diabetic Retinopathy Auxiliary Diagnostic Software

Read more about the guidelines here.

That concludes our June 2026 MedTech news roundup. We’ll be back in July with more medical device news and updates.

Found this useful? To receive our MedTech news direct to your inbox, you can subscribe to our monthly Knowledge update.