Our February MedTech news covers calls from the European MedTech industry for the EU to become a full member of MDSAP, and for the withdrawal of the AI Liability Directive respectively. The Swiss Federal Council’s regulatory approach for AI also features, along with MHRA guidance on registration of IVD devices with expiring CE certificates, and Health Canada’s pre-market guidance for ML-enabled medical devices.
Keep scrolling for the IMDRF guidance on medical device software, as well as an important US MedTech news update regarding the Trump administration’s impact on FDA content.
For all this and more, read on.
MedTech news from Europe
European MedTech industry calls for EU to become full member of MDSAP
MedTech Europe and COCIR have jointly urged the European Union to become a full member of the Medical Device Single Audit Program (MDSAP), recognising its certificates for CE marking.
Operational since 2017, the MDSAP program has proven to increase regulatory efficiency and cooperation. The EU’s full membership would bring multiple benefits regarding the device certification process, ultimately expediting patient access to innovative medical technologies.
EU Commission launches coordinated assessment for CI/PS pilot
The European Commission has launched a pilot program for the coordinated assessment of clinical investigations and performance studies across multiple Member States, allowing sponsors to submit a single application to streamline interactions and harmonise approval processes. The initiative aims to reduce administrative burden, enhance transparency, and ensure consistency in assessments, with participation from countries including Austria, Belgium, France, Germany, and others.
Industry coalition calls for withdrawal of AI Liability Directive
Together with 11 other associations, MedTech Europe has called on EU policymakers to withdraw the AI Liability Directive (AILD) proposal. The joint statement was issued on 29 January, and outlines concerns that the directive risks adding legal complexity – which would harm EU competitiveness by increasing regulatory burden and deterring investment into AI innovation.
Read the joint statement in full here.
MedTech news from Switzerland
Federal Council decides on Swiss regulatory approach for AI
In November 2023, the Federal Council commissioned the Federal Department of the Environment, Transport, Energy and Communications (DETEC) and the Federal Department of Foreign Affairs (FDFA) to prepare an overview of possible regulatory approaches to AI.
After being presented earlier this month, the overview has prompted the Federal Council to decide on a Swiss regulatory approach for AI based on three objectives: strengthening Switzerland as a location for innovation, safeguarding the protection of fundamental rights including economic freedom, and increasing public trust in AI.
The Federal Council has set out the following points:
- The Council of Europe’s AI Convention will be incorporated into Swiss law.
- Where legislative amendments are necessary to achieve this goal, these should be sector-specific as far as possible. General, cross-sector regulation is limited to central areas relevant to fundamental rights, such as data protection.
- In addition to legislation, legally non-binding measures are also being developed to implement the convention and may include self-declaration agreements or industry solutions.
Read more on the approach here.
Swissmedic campaign reveals legacy device PMS documentation non-conformities
On 17 February Swissmedic shared the findings of its focus campaign to assess compliance with the post-market surveillance requirements of the Medical Devices Ordinance (MedDO) for higher-risk legacy devices.
The campaign assessed compliance with the post-market surveillance requirements for 30 legacy devices in risk classes IIa and higher, with the sample generated based on vigilance data. The results reported that non-conformities were raised in 20 out of 30 cases, and a total of 85 non-conformities with the requirements established in Articles 56, 58, 60 and 61 of MedDO were identified.
The review demonstrates that despite the applicability of the MedDO post-market requirements since 26 May 2021, not all manufacturers of higher-risk legacy devices are adequately fulfilling their implementation.
Swiss Good Practice in the Maintenance of Medical Devices guidance now available
The revised “Swiss Good Practice in the Maintenance of Medical Devices” guidance is now available. Swissmedic mandates that all hospitals adhere to the “Schweizerische Gute Praxis für die Instandhaltung von Medizinprodukten” (GPI) guidelines for medical device maintenance, as stipulated in the MedDO and the IvDO, with compliance verified through inspections. Any deviations must be addressed, justified, and documented appropriately.
MedTech news from the UK & Canada
UK’s MHRA publishes guidance on registration of IVD devices with expiring CE certificates
This month the UK’s MHRA has published guidance on the registration of certain in vitro diagnostic devices reliant on expired or expiring CE certificates or declarations of conformity.
The EU has extended the validity of certain Directive 98/79/EC on in vitro diagnostic (IVD) devices (EU IVDD) certificates and declarations. The guidance sets out what this means for device registration and managing registered devices in the MHRA Device Online Registration System (DORS).
MHRA shares principles for importing IMPs from approved countries
The MHRA has shared guidance for managing and overseeing the import of investigational medicinal products (IMPs) to Great Britain from listed countries. Whilst the guidance relating to the importation of IMPs from an approved country has been in force since 2022, the MHRA has this month updated it to consider the EU implementation of the Clinical Trials Regulation 536/2014 related to EU qualified person (QP) certification. Read more on this here.
Health Canada shares pre-market guidance for ML-enabled medical devices
Health Canada has shared guidance to provide manufacturers with requirements and considerations for demonstrating the safety and effectiveness of machine-learning enabled medical devices, including the use of predetermined change control plans (PCCPs) to manage planned modifications.
The document provides guidance to manufacturers who are submitting a new or amendment application for Class II, III and IV MLMD under the regulations. The information in the guidance relates to the ML system of an MLMD – it doesn’t cover the non-ML information required in a medical device licence application.
International MedTech news
IMDRF releases guidance on medical device software
At the end of last month, the IMDRF shared two guidance documents regarding medical device software.
“Good machine learning practice for medical device development: Guiding principles” outlines the 10 guiding principles for Good Machine Learning Practice (GMLP) that form a call to action to international standards organisations, international regulators, and other collaborative bodies to further advance GMLP. Areas of collaboration include research, the creation of educational tools and resources, international harmonization, and consensus standards, to inform regulatory policies and regulatory guidelines.
“Characterization Considerations for Medical Device Software and Software-Specific Risk” promotes and informs on clear and accurate characterisations of medical device software, including developing an intended use/intended purpose statement. It also aims to introduce a general strategy for characterising software-specific risks, drawing on the essential components of a comprehensive characterisation of medical device software.
US MedTech news update
Trump administration impacts FDA content
In January this year, the Trump administration issued directives requiring federal health agencies, including the FDA, to obtain White House approval before releasing public communications. This directive led to a temporary freeze on new regulations, guidance documents, and public communications, including website updates, until 1 February.
Additionally, the administration mandated the removal of certain content from federal health agency websites, particularly materials related to diversity, equity, and inclusion. This led to the deletion of numerous webpages and datasets, including those covering clinical trial diversity and LGBTQ+ health information.
These actions have faced legal challenges. On 4 February, medical advocacy group Doctors for America sued the main US health agencies over the sudden removal of websites containing public health information in response to an executive order by President Trump targeting what his administration deemed to be “gender ideology extremism.” Doctors for America argued that the deletions impede researcher access to critical information necessary for patient care and public health policy development.
On 11 February, US District Judge John Bates ordered the CDC and FDA to restore the removed websites, ordering the government to consult with Doctors for America to identify any other materials that doctors rely on and restore them by 14 February.
The combination of communication freezes and content removals has contributed to an absence of new updates for this month regarding the US medical device regulatory situation more generally.
Our Regulatory team will continue to monitor this ongoing situation and share relevant updates as they arise.
That concludes our February 2025 MedTech news roundup. We’ll be back at the end of March with more medical device news and updates.
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