Our April 2025 MedTech news covers new harmonised standards from the EU Commission, updates from MedTech Europe on IVDR, MDR, and EUDAMED, and the latest from Swissmedic on RWE use and IMDRF membership. New MHRA guidances on EUA and safety communications also feature, as well as the recent court decision regarding the FDA Final Rule on LDTs. For all this and more, read on.
MedTech news from the EU & Switzerland
EU Commission publishes new harmonised standards
This month the EU Commission published two new harmonised standards regarding medical devices and IVDs.
Implementing decision EU 2025 / 681 under the MDR involves medical gloves for single use, sterilization of medical devices, and patient handling equipment used in ambulances, whilst Implementing decision 2025 / 679 under the IVDR relates to sterilization of medical devices.
MedTech Europe responds to consultation on targeted evaluation of IVDR & MDR
MedTech Europe has submitted its response to the consultation on the targeted evaluation of the IVDR and the MDR.
In its response, MedTech Europe provides recommendations for improving the current regulatory landscape, emphasising the need for “practical and balanced approaches that support industry sustainability and facilitate patient access to medical technologies”. Read the organisation’s full submission here.
MedTech Europe advocates efficient use of EUDAMED CIPS module
MedTech Europe has published a position paper on the Clinical Investigation and Performance Studies module (CIPS) within EUDAMED.
Compliance activities for the EUDAMED CIPS module are foreseen to be resource-intensive for users due to manual processes and submission requirements. In response, MedTech Europe has made requests which seek to eliminate duplication in administrative processes and increase automation for submission mechanisms to ensure a smooth transition to the implementation and use of the CIPS module. Read the paper here.
Swissmedic updates position on RWE use
This month, Swissmedic updated its position paper on the use of real-world evidence (RWE) to include an annex with an overview of relevant international guidelines and publications that reflect the current situation in science and technology. According to Swissmedic, the annex serves as additional guidance for the scientific and regulatory assessment of RWE in the authorisation process. Access the position paper here.
Swissmedic joins IMDRF Management Committee
Last month, Swissmedic was accepted as a member of the Management Committee of the International Medical Device Regulators Forum (IMDRF), enabling the agency to play an even more active role in shaping the international regulatory landscape.
According to Swissmedic, authorities and economic operators are set to benefit from increased harmonisation, leading to reduced regulatory work and improved international recognition. Read more on this here.
MedTech news from the UK
MHRA publishes new EUA guidance
At the end of last month, the UK’s MHRA published new guidance on exceptional use authorisation (EUA) of medical devices. An EUA allows non-UKCA/CE certified medical devices to be placed on the UK market when required for the protection of public health.
This type of authorisation is granted by the MHRA for a specified period, and exempts manufacturers from certain regulatory requirements. EUAs are subject to specific conditions and require manufacturers to demonstrate ongoing progress towards full conformity with the applicable regulations.
The new guidance, available to read here, outlines how to apply for an EUA.
MHRA shares new guidance on safety communications for medical devices
The MHRA has shared an overview of the different types of MHRA safety communications regarding medicines, medical devices, and other healthcare products.
The overview includes what safety communications exist, who they are aimed at, and information on related decision-making. You can read the guidance here.
MedTech news from the US & Canada
US District Court rules to vacate FDA Final Rule on LDTs
At the end of last month, the US District Court for the Eastern District of Texas ruled that the FDA’s Final Rule on Laboratory Developed Tests (LDTs), be vacated and set aside. The Final Rule, published in 2024, phases out enforcement discretion in favour of standard medical device requirements.
The recent court ruling prevents the LDT Final Rule – a rule heavily criticised by many clinical laboratory industry stakeholders – from going into effect. The Court remanded the matter to the Secretary of the U.S. Department of Health and Human Services (HHS) for further consideration. Read the ruling here.
Health Canada shares draft guidance on co-packaged drug products
Health Canada has drafted a guidance document on co-packaged drug products. Open for comments until 18 May this year, the document explains the regulatory requirements for co-packaged drug products and their components. Read more on the guidance and how to share feedback here.
MedTech news from China & Australia
NMPA issues seven guidelines for IVD reagents
On 31 March, China’s NMPA published seven IVD reagents guidelines to support market entry and regulatory clarity. As part of efforts to accelerate IVD innovation, the guidelines aim to provide manufacturers with more product-specific guidance and clarity in the registration process. You can read more about the guidelines here.
NMPA shares guidance on clinical trial inspections
Last month, NMPA published the “Medical Device Clinical Trial Inspection Guideline” to provide a comprehensive framework for evaluating the quality and compliance of clinical trials for medical devices and IVDs.
The guidance focuses on ensuring the integrity of trial data, safeguarding participant rights, and maintaining regulatory compliance, covering key areas such as trial conditions and protocols, implementation processes, data traceability, and device management. Find out more here.
Australia’s UDI framework now in effect
Australia’s TGA has announced that its Unique Device Identification (UDI) regulatory framework is now in effect, offering enhanced identification and traceability of medical devices to support a more effective regulatory framework.
The announcement follows the approval of the Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025. You can access guidance on the UDI framework here.
That concludes our April 2025 MedTech news roundup. We’ll be back in May with more medical device news and updates.
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