Our MedTech news for April 2026 covers updates on device classification and the expansion of WET devices under the EU MDR, EMA’s pilot programme to support breakthrough medical devices and IVDs, the EU Commission’s national requirements overview for clinical investigations and performance studies, and the new MIR form that’ll be mandatory from May.
News from the UK’s MHRA on its fee waiver programme for smaller sized enterprises, required information for device registration, and clinical investigations also features, as well as updated guidance from Health Canada on ML-enabled medical devices, and China’s new software standard. For all this and more, read on…
MedTech news from the EU
Updated Manual on Borderline & Classification under MDR & IVDR published
Version 5 of the Manual on Borderline and Classification under the EU MDR and IVDR has been published this month, updating guidance to align with the latest Borderline and Classification Working Group agreements.
The manual incorporates new cases for classifying and qualifying products – such as specialised solutions, creams, and software – to ensure harmonised application across the EU. Addressing complex boundary areas between medical devices/IVDs and medicinal products, cosmetics, and biocides, the updates place stronger emphasis on the intended purpose, mode of action, and risk level, as agreed upon through the Helsinki Procedure. Access the updated manual here.
MDCG updates guidance on medical device classification
This month, the MDCG updated its guidance on medical device classification, strengthening rules for implantable and active devices.
The key changes in MDCG 2021-24 rev.1 include updating the definition of implantable devices to focus on “clinical” rather than “surgical” procedures, expanding practical notes for rules 8, 9, 10, 12, 16, and 22, and adding specific guidance for spinal products and automatic external defibrillator (AED) pads. Read the updated guidance here.
WET devices legally expanded under MDR
On 20 March, the EU Commission officially adopted two delegated regulations (C(2026) 1798 and C(2026) 1809) to expand the list of Well-Established Technologies (WET) under the EU MDR.
The delegated regulations update Article 61(6)(b) of the MDR to include more devices as WET, easing the conformity assessment process. Entering into force 20 days after publication in the Official Journal of the European Union, these acts exempt certain implantable and Class III devices from clinical investigations and, for some, technical documentation assessments.
Whilst WET was never formally defined in the MDR, by inference they’re defined to be “sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors” (in Article 18(3), Article 52(4), and Article 61(6)(b)). According to MDCG-2020-6, WET devices are understood to be simple devices with stable designs and recognised safety and clinical performance, as well as a long history on the market. Read more on the legislation here and here.
EMA plans pilot programme to support breakthrough medical devices & IVDs
In quarter two this year, EMA will launch a pilot programme to support breakthrough medical devices and in vitro diagnostics by testing a pathway that accelerates patient access to highly innovative technologies whilst maintaining the EU’s high standards for safety and performance.
Building on the recently adopted Guidance on Breakthrough Devices MDCG 2025-9, the pilot will be crucial in shaping a possible future framework for breakthrough medical devices, which the Commission included in its December 2025 proposal to revise the MDR and IVDR. Through the pilot, manufacturers of designated breakthrough devices will be able to benefit from enhanced regulatory support and priority scientific advice from the medical device expert panels administered by EMA. Find out more about the pilot here.
EU Commission updates national requirements overview for clinical investigations & performance studies
On 21 April, the EU Commission updated its overview of Member State-specific national requirements for clinical investigations (under MDR) and performance studies (under IVDR). Aiming to streamline regulatory compliance across the EU, this update reflects ongoing harmonisation efforts. Access the overview here.
EU Commission’s new MIR form mandatory from May
The EU Commission has shared a new manufacturer incident report (MIR) form this month, which will be mandatory from 1 May this year. You can access the new form here.
MedTech news from the UK
UK’s MHRA extends fee waiver programme for micro and small sized enterprises
The MHRA is extending its fee waiver programme for eligible micro and small sized enterprises intending to conduct clinical investigations for innovative medical devices.
The programme will run from 20 April this year until 5 April 2027 – or until all fee waivers have been granted. A total of ten fee waivers will be available for Class I, IIa, IIb, and Class III devices, (but not active implantable devices), and the usual clinical investigation application fee will be completely waived for successful applicants.
The programme aims to support patient access to innovative devices by testing the impact of removing regulatory costs for smaller organisations, where fees might act as a barrier to growth or innovation. Find out more about the pilot programme here.
MHRA updates required information for device registration
This month the MHRA has made several updates to its required information regarding medical device registration.
An updated DORS Attributes list and fees section are included in the revisions, as well as the removal of the Renew Registration process and certain fees. New and updated video tutorials are also now available regarding payment for annual fees and new device registrations, adding addresses, and removal of the Renew Registration process. Find out more here.
Guidance released on clinical investigations in Great Britain
On 31 March the MHRA shared its guidance on how manufacturers should undertake a clinical investigation for a medical device to ensure compliance with medical device regulations.
All the information in the guidance applies in Great Britain, however different rules apply in Northern Ireland for parts of the process. The Northern Ireland Protocol requires Northern Ireland’s continued alignment with EU rules for devices as set out in the EU MDR and IVDR. Read the full guidance here.
Is a clinical investigation required for your medical device? MHRA publishes guidance to help you decide
At the end of last month, the MHRA published guidance to help manufacturers determine whether a clinical investigation is necessary according to the UK Medical Device Regulations 2002 (SI 2002, No 618, as amended). The guidance applies to general medical devices and active implantable medical devices. Read the guidance here.
MedTech news from Canada & China
Health Canada publishes pre-market guidance for ML-enabled medical devices
This month, Health Canada shared updated pre-market guidance for machine learning-enabled medical devices. The document provides guidance to manufacturers who are submitting a new or amendment application for Class II, III, and IV MLMD under the Canadian Regulations.
Covering advice on good machine learning practice, design, risk management, data selection and management, development and training, testing and evaluation, clinical validation, transparency, and post-market monitoring, the information in the guidance relates to the ML system of an MLMD – but does not cover the non-ML information required in a medical device licence application. Read the guidance here.
Updated guidance on T&Cs for Class II to IV medical devices
On 1 April, Health Canada shared updated guidance that provides direction to medical device licence holders on the use of T&Cs imposed on Class II to IV medical devices under section 36 of the Medical Devices Regulations. The guidance explains the purpose of the T&Cs and outlines the process that will be applied when they’re imposed, amended, or removed. Read more on this here.
Guidance on interpreting “significant change” from Health Canada
At the end of last month, Health Canada published guidance on how to interpret “significant change” as defined in the Medical Devices Regulations.
Its purpose is to help manufacturers determine whether a proposed change to a Class III or IV medical device licence is significant and requires them to submit an amended medical device licence application before implementing the change. The guidance presents the types of changes included in the regulatory definition of significant change, along with detailed examples, so that manufacturers may interpret and apply the regulations consistently. Read the guidance here.
China’s new software standard shifts focus to risk management
Last month, China’s NMPA released the revised YY/T 1406-2026: Guidance on the Application of GB/T 42062 to Medical Device Software, effective 1 March 2027.
Replacing YY/T 1406.1-2016, it clarifies how the risk management principles of GB/T 42062-2022 should be implemented within the software lifecycle defined by YY/T 0664-2020. The document marks a structural shift in regulatory expectations and demonstrates China’s move from a process-driven approach – focused on whether software development steps are documented – to a model that emphasises whether risk is systematically identified, controlled, and monitored across the entire lifecycle. Under this new framework, risk management must be embedded into every stage of software development and operation. Read more on the standard here.
That concludes our April 2026 MedTech news roundup. We’ll be back in May with more medical device news and updates.
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