Welcome back – and Happy New Year from our Congenius Knowledge Team!
Our MedTech roundup for January 2026 kicks off with a recap of December industry news, and the latest happenings from the new year so far. Read on for new MDCG guidance on PMS and Breakthrough Devices, plus the EU Commission’s proposal to simplify MDR / IVDR. UK updates cover MHRA fee changes, and revised clinical investigation and HIE guidance. Key FDA guidances on wellness products, CDS, and RWE also feature, as well as news from Brazilian and APAC regulators on this year’s priorities, borderline products, and joint regulatory reliance. See more below…
MedTech news from the EU
EU Commission proposes amends to EU regulatory framework for medical devices
On 16 December 2025, the European Commission published a proposal to amend the EU regulatory framework for medical devices and in-vitro diagnostic medical devices.
The objective is to simplify existing rules, reduce administrative burden, improve predictability, and support innovation and competitiveness, while maintaining a high level of patient safety and public health protection.
In this 5-minute guide, our Founder Jörg Dogwiler summarises the key elements in the proposal, indicative timings for implementation, and practical implications for medical device and IVD manufacturers. And you can read the full proposal from the EU Commission here.
MDCG releases guidance on Breakthrough Devices under MDR & IVDR
In December last year, the MDCG released guidance on Breakthrough Devices (BtX) under MDR and IVDR. The guidance covers the process and regulatory considerations relevant for qualifying, assessing, and certifying breakthrough medical devices and IVDs, with its roll-out pilot expected to launch in Q2 this year. Read the full guidance here.
MDCG shares guidance on post-market surveillance for medical devices & IVDs
MDCG 2025-10 is applicable to all medical devices and in vitro diagnostic medical devices (IVDs). The guidance describes the PMS system and its main activities, describes the PMS plan, and clarifies the interactions of the PMS system with other key aspects of the QMS. You can access the guidance here.
MedTech news from the UK
MHRA publishes device registration fee changes
This month, the UK’s MHRA published device registration fee changes that will apply from 1 April 2026. A statutory fee will be payable from this date for adding certain devices to a registration record, adding new / additional represented manufacturers, or changing device characteristics, the status of an IVD, the legislation of a device, or a UK Responsible Person. Find out more here.
MHRA updates guidance on clinical investigations for medical devices
The MHRA has made various updates to its guidance on clinical investigations for medical devices. Updates include the addition of the latest version of the QSR Template Guidance, new guidance on investigational medicinal products and device reviews, webpage changes to ease usability, and updates to guidance on healthcare establishments, payments for clinical investigations, and quarterly summary reports. For more information, see here.
Guidance on the HIE updated to support safe use of medical devices
The MHRA has updated its guidance on the Health Institution Exemption (HIE), clarifying how health institutions (e.g., NHS Trusts) can design, make, and use general medical devices safely. The guidance, which supports safer bespoke device development within UK healthcare settings, is available to read here.
MedTech news from the US
FDA publishes final guidance on general wellness products
This month, the FDA published updated final guidance on general wellness products that clarifies regulatory boundaries and oversight expectations for low-risk products that promote a healthy lifestyle.
The guidance includes an interpretation of the FD&C Act’s provision on exclusions for software intended for “maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition” – and its application to general wellness products. Read more on this here.
Final guidance released on Clinical Decision Support (CDS) software
Issued this month, the final guidance on clinical decision support software clarifies the FDA’s thinking on the types of clinical decision support (CDS) software functions that are excluded from the definition of a device according to the FD&C Act.
The guidance emphasises non-device status for tools that display / analyse patient data, support HCPs rather than patients, and allow for expert override. Access the final guidance here.
FDA launches TEMPO digital health pilot
In December, the FDA announced the launch of its Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot: a voluntary program to accelerate access to certain digital health devices for chronic disease care, with real-world performance data collection.
Developed by the FDA’s CDRH, the pilot will evaluate a new, risk-based enforcement approach that supports digital health devices intended for use to improve patient outcomes in cardio-kidney-metabolic, musculoskeletal, and behavioural health conditions. Find out more about the pilot, and how to participate, here.
FDA shares updated eCopy Program guidance
FDA has shared updated final guidance on its eCopy requirements for medical device submissions. Important for ensuring premarket documentation quality, the guidance provides clarifications on the eCopy Program related to its intersection with the eSTAR Program and the availability of the CDRH Portal. Access the final guidance here.
Final guidance released on use of RWE to support regulatory decision-making
In December, the FDA released final guidance that clarifies how real-world data (RWD) is evaluated to determine its sufficient quality for generating real-world evidence (RWE) that can be used in regulatory decision-making for medical devices. Relevant for clinical strategy and post-market data use, the guidance can be found here.
MedTech news from Brazil & Asia Pacific
Brazil’s ANVISA announces 2026-2027 regulatory priorities
ANVISA has published its regulatory priorities for 2026-2027, focusing on quality systems, classification rules, regulatory efficiency, and potential implications for foreign manufacturers and MDSAP alignment. Read more on this here.
Australia’s TGA updates regulatory status of borderline products
Australia’s Therapeutic Goods Administration has updated its approach to borderline products (products with unclear medical vs non-medical classification). The update impacts classification strategy, regulatory pathways, and market access planning for affected products. Find out more here.
Malaysia’s MDA and Thailand’s FDA launch joint regulatory reliance pilot program
In December, Malaysia and Thailand launched a regulatory reliance pilot, allowing partial reliance on approvals or assessments from trusted reference authorities. The pilot program, scheduled from 1 February 2026 to 30 April 2026, aims to streamline the registration process for Class B, C, and D medical devices – and may significantly reduce review timelines for device approvals in these markets. Find out more here.
That concludes our January 2026 MedTech news roundup. We’ll be back in February with more medical device news and updates.
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