Our Summer 2026 MedTech news roundup covers a new MDCG position paper on UDI assignment between manufacturers and distributors, and the latest on MDR revisions and swissdamed. The MHRA’s new AI health innovations regulatory sandbox and AVT guidance also feature, as well as updates and guidelines from the FDA and NMPA on device classification, user fees, brain-computer interface devices and more…
On 22 July, the Medical Device Coordination Group published MDCG 2026-5, a position paper clarifying UDI assignment responsibilities between manufacturers and distributors, and between manufacturers and the EU UDI issuing entities. The document aims to ensure consistent enforcement across Member States and within EUDAMED. Read the full position paper here.
On 30 June, the European Parliament’s Committee on Public Health published its draft report on the Commission’s proposal, COM (2025) 1023, to simplify and reduce the burden of the rules on medical devices and in vitro diagnostic medical devices.
The proposal also amends Regulation (EU) 2022/123 on EMA support for the expert panels on medical devices, and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation in its Annex I. Read the report here.
On 29 June, two delegated acts on well-established technologies (WET) under the MDR were published in the Official Journal of the EU – collectively expanding the list of WET devices under the MDR.
Commission Delegated Regulation (EU) 2026/1359 expands the list of Class IIb implantable devices exempted, under Article 52(4), from the requirement for an assessment of the technical documentation for every device. Commission Delegated Regulation (EU) 2026/1451 extends the list of implantable and Class III devices exempted from the obligation to perform clinical investigations.
Find out more on 2026/1359 here and 2026/1451 here.
As of 1 July 2026, registration in swissdamed – Switzerland’s national database for medical devices and in vitro diagnostic medical devices – became mandatory under Article 108 of the MedDO. The standardised digital system replaces the previous notification procedures, with a transition period running until 31 December 2026. Read more on what’s changing here.
On 30 July, the UK’s MHRA launched a regulatory sandbox for AI-enabled health innovations. Expressions of interest are being invited from AI-enabled medical device manufacturers and NHS provider organisations to participate in the London Region I pilot. Find out more here.
On 29 July, the MHRA published the first version of its guidance on ambient voice technology (AVT) products, clarifying the qualification and classification of AVT products as medical devices when placed on the market or put into service in Great Britain. To the surprise of many, the MHRA has decided that summarisation of a clinical conversation is not a medical purpose. Read more here.
On 17 August, the FDA issued a final order reclassifying in situ hybridization (ISH) test systems used with a corresponding approved oncology therapeutic product from Class III into Class II, subject to premarket notification.
On the same day, the FDA proposed reclassifying diagnostic endoscopic light source systems – to be renamed cystoscopic systems intended as an aid for detection of bladder cancer – from Class III into Class II.
On 3 August, the FDA reopened the comment period for its proposed rule to modify certain terminology in Title 21 of the CFR, replacing the term “gender” with “sex” in line with Executive Order 14168.
The rule was first proposed in May 2026 and, if finalised, would apply across drug and device regulations. Read more on this here.
On 30 July, the FDA announced the fee rates and payment procedures for medical device user fees for fiscal year 2027, authorised under the Medical Device User Fee Amendments of 2022 (MDUFA V).
The rates apply from 1 October 2026 until 30 September 2027 and include provisions for reduced small business fees.
Pre-subs continue to be free for FY2027; however, draft proposals for MDUFA VI (2028-2032) introduces pre-submission fees which will function as an advance deposit that will be credited back from the future marketing submission fee. Find out more on the user fee rates here.
On 31 July and again on 18 August, the NMPA’s device evaluation centre released draft technical review points for implantable brain-computer interface (BCI) hand motor function compensation systems, open for public comment. Read the review points here.
On 21 July, the NMPA’s Centre for Medical Device Evaluation published 57 registration review guidelines in a single batch, spanning categories including cardiac magnetic signal acquisition equipment, sterilisation equipment, dental implant materials, orthopaedic devices, and a wide range of IVD reagents. Find out more on this here.
That concludes our Summer 2026 MedTech news roundup. We’ll be back in September with more medical device news and updates.
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