Our March MedTech news covers EU-US trade tensions, the Clean Industrial Deal, updated guidance on IVD classification, and calls for harmonised technical data digitalisation. The appointment of a new FDA commissioner also features, as well as guidance from Health Canada, and requirement updates from China’s NMPA. Read on for more…
MedTech news from Europe
EU-US trade tensions could endanger patient care and MedTech innovation
Medtech Europe has called on the EU to ensure that medical devices and IVDs and their essential inputs such as raw materials and accessories are exempt from any retaliatory tariffs.
The organisation highlighted that tariffs would increase production and distribution costs, delay patient access to critical innovations, and hinder the ability of domestic industries to achieve efficiencies, foster innovation, and remain globally competitive.
Read the full statement from Medtech Europe here.
EU Commission presents Clean Industrial Deal
On 26 February the EU Commission presented its first 100-days initiative, the Clean Industrial Deal, along with an Affordable Energy Action Plan and the first Simplification Omnibuses on Sustainability and Investment.
Key aspects of the deal include accelerating and scaling access to affordable, clean energy as a key decarbonisation lever in the MedTech industry, as well as the potential of the circular economy and a reinforced single market.
Find out more on the deal here, and for more on the effect of sustainability regulations on the medical devices industry, see here.
Joint calls for clarity on clinical strategy discussions
MedTech Europe, AESGP, MedTech & Pharma Platform and COCIR have expressed concerns regarding the recently updated MDCG 2019-6: Requirements relating to notified bodies rev. 5.
The organisations suggest that the updated documentation has not addressed the ongoing absence of clinical strategy discussion in the pre-submission phase. Consequently, they argue that the gap in clinical evidence expectations will persist – with serious implications for the EU MedTech industry including the continuity of devices. Read the joint position paper here.
MDCG updates guidance on IVD classification
This month the MDCG updated its guidance on classification rules for in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 – EU IVDR. The update involves some revision of examples provided, as well as some minor changes. Access the updated guidance MDCG 2020-16 rev. 4 here.
Medtech Europe proposes harmonised technical data digitalisation
This month Medtech Europe released a position paper that suggests exploring a transition to a harmonised model for the digitalisation of technical data to improve the efficiency of Technical Documentation management. Read more on this here.
EU Commission launches second call for EURLs for high-risk IVDs
Last month the EU Commission launched a second call to Member States to submit further applications on behalf of their candidate laboratories for designation of EURLs (EU reference laboratories).
The first of two waves is open to applications for Class D devices that detect or quantify markers of arbovirus or parasite infection or detect blood grouping markers. Indicatively, laboratories must submit applications to their Member State by 15 April.
The second wave is open to a further eight categories of Class D devices, with applications due by January next year. Find out more on this here.
MedTech news from the US & Canada
Marty Makary confirmed as FDA commissioner
On 25 March, the US Senate confirmed Marty Makary to be the Food and Drug Administration commissioner. Makary was confirmed by a 56-44 vote, picking up three Democrats.
Makary, a Johns Hopkins University surgeon and researcher, gained prominence on Fox News and other conservative outlets for his contrarian views during COVID-19 – questioning the need for masking, and expressing concerns about vaccinations in young children.
Makary will take over the FDA amidst significant workforce cuts at the agency, imposed by Elon Musk’s Department of Government Efficiency (DOGE). Find out more here.
Health Canada shares draft guidance on co-packaged drug products
This month, Health Canada shared draft guidance on co-packaged drug products. The document includes a definition of co-packaged products, and clarification on drug identification numbers, requirements for authorising, packaging, labelling and distributing a product, and submission requirements for post-market changes.
The guidance is open for consultation until 18 May, with a final guidance to follow based on public feedback. Read more about the guidance here.
MedTech news from China
China’s NMPA updates clinical trial requirements
On 12 March, China’s NMPA published “Inspection Checkpoints and Judging Principles for Clinical Trial” following the trial version that was released in June last year.
Key areas addressed in the guidance include clinical trial conditions and compliance, protection of subject rights, clinical trial protocol, implementation of clinical trials, data recording, traceability, reporting, and management of trial devices.
Inspection results demonstrate stricter requirements for overseas medical device manufacturing
An analysis of China’s 2024 inspection data for overseas manufacturers has revealed heightened post-pandemic scrutiny, the growing reliance on remote GMP audits, and enhanced interprovincial collaboration in quality inspections. Read more on this here.
85 NMPA standards to be revised this year
On 24 February, NMPA issued the “2025 Medical Device Industry Standards Revisions Plan”. Six mandatory and 79 recommended standards will be revised or established.
The 85 standards cover medical fields including anaesthesiology, cardiovascular, dentistry, and more. They specify requirements for devices such as implants, radiology equipment, and diagnostics, ensuring safety and efficacy. For the full list categorised by indications see here.
That concludes our March 2025 MedTech news roundup. We’ll be back at the end of April with more medical device news and updates.
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