Our March 2026 MedTech news covers the latest on the EU / Swiss MRA, Team-NB’s thoughts on the MDR / IVDR revision, and the process for requesting regulatory advice from the MHRA. Final FDA guidance on medical devices with weight loss indications also features, as well as updates from Asian regulators on clinical trial protocol requirements and regulatory reliance. Read on for this and more…

MedTech news from the EU, Switzerland, & UK

EU & Switzerland strengthen mutual recognition

On 2 March the EU and Switzerland signed a broad package of agreements including an update of their Mutual Recognition Agreement (MRA).

The initiative aims to restore a more stable and predictable framework for market access and regulatory cooperation between both regions, marking a significant political step towards re-establishing mutual recognition in the medical devices sector after Switzerland’s treatment as a third country since 2021. Read more on the agreements here.

Team-NB reflects on MDR / IVDR revision

Team-NB has published a position paper supporting the overall objective of the recent MDR / IVDR revision to improve predictability, consistency, and transparency of the regulatory framework.

However, the organisation raises significant concerns regarding potential reductions in control measures, which could negatively impact patient safety, trust, and market surveillance. The paper also questions the EU Commission’s assumptions on cost savings and highlights the operational realities of Notified Bodies. Access the full paper here.

MHRA updates form for regulatory advice requests

This month the UK’s MHRA updated its form: “Ask for regulatory advice for medical devices”. To request a regulatory advice meeting, users must submit a request by completing this request form, which asks for relevant background information, including a list of questions they would like advice on.

The MHRA will acknowledge application requests following submission, then propose a meeting date and time within 15 days. The time to a meeting will be reliant on the subject matter and expertise needed, so early planning is encouraged. Find out more here.

MedTech news from the US

FDA issues final guidance on medical devices with weight loss indications

On 12 March the FDA issued final guidance providing recommendations on non-clinical testing and clinical study design for medical devices intended for weight loss or weight management.

The guidance clarifies expectations for premarket submissions (e.g., PMA, 510(k), De Novo), including performance evaluation, safety assessment, and study endpoints. It also reflects a more structured benefit-risk framework and supports consistent regulatory evaluation of obesity-related devices. Read the final guidance here.

QMSR enters transition phase

Effective since 2 February this year, the Quality Management System Regulation (QMSR) now enters the active transition phase.

The QMSR amends the current good manufacturing practice (CGMP) requirements of 21 CFR Part 820 and incorporates by reference ISO 13485 – harmonising the FDA’s CGMP regulatory framework with that of other regulatory authorities.

The QMSR regulation applies to manufacturers of finished devices who intend to commercially distribute their medical devices. Since coming into force last month, manufacturers should now focus on implementation readiness and inspection preparedness. Read more about the QMSR here.

MedTech news from Asia

China’s NMPA toughens requirements for clinical trial protocols

China’s NMPA continues to toughen requirements for clinical trial protocols for innovative medical devices this month, publishing its “Pre-Review of Clinical Trial Protocols for Innovative Medical Devices” on 13 March.

Emphasising structured study design, clear endpoint definitions, and regulatory alignment early in development, the update reflects a broader shift towards more standardised and predictable clinical evaluation pathways, particularly for high-risk and novel technologies.

The pre-review also highlights increasing interaction between sponsors and regulators during protocol development, supporting faster and more efficient approval processes. Find out more here.

Malaysia and Singapore continue regulatory reliance

At the end of last month, Malaysia’s MDA and Singapore’s HSA successfully completed a six-month regulatory reliance pilot and confirmed ongoing implementation of the program as a result.

The initiative allows the regulators to leverage each other’s prior assessments, enabling faster review timelines for Class B-D devices (e.g., reduction of ~30 working days or ~30% review time). Read more about the pilot and its ongoing implementation here.

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

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