The week of 22–28 June 2026 brought several relevant regulatory updates in the medical device and in vitro diagnostic (IVD) sectors. The main developments included an ESMINT-led European multisociety consensus on clinical evidence for high-risk endovascular stroke devices, an FDA data integrity update concerning third-party testing, an MHRA annual registration fee deadline extension, an FDA classification order for a preeclampsia prognostic test, and an EU HTA update relevant to high-risk medical devices and IVDs.
ESMINT-Led Consensus Addresses Clinical Evidence Standards for High-Risk Endovascular Stroke Devices
Team-NB reported the publication of an ESMINT-led European multisociety consensus paper on clinical evidence standards for high-risk endovascular devices used in ischaemic stroke.
Consensus was developed with ESMINT, the European Stroke Organisation and the European Society of Neuroradiology, with input from Team-NB experts in stakeholder discussions.
The paper addresses indication-specific clinical evaluation considerations for thrombectomy devices under the MDR, including study design, endpoints, post-market evidence generation and governance.
The publication provides sector-specific context on clinical evidence expectations for a high-risk device category under Regulation (EU) 2017/745.
Source: ESMINT / Team-NB
Reference: ESMINT-led European Multisociety Consensus Defines Clinical Evidence Standards for High-Risk Endovascular Stroke Devices, Team-NB / ESMINT, 26 June 2026
FDA Posts Data Integrity Notifications for Medical Device Submissions
On 25 June 2026, the U.S. Food and Drug Administration updated its “Notifications on Data Integrity – Medical Devices” page.
The page states that the Center for Devices and Radiological Health has noted an increase in unreliable testing data generated by third-party testing facilities on behalf of device manufacturers and sponsors.
FDA lists general correspondence letters issued to three testing facilities and states that all study data from studies conducted at those facilities will be rejected until the firms adequately address the identified issues.
The update is relevant for manufacturers and sponsors relying on third-party testing, who should ensure that submitted study data are traceable, reliable and generated by facilities able to address FDA data integrity expectations.
Source: FDA – Center for Devices and Radiological Health (CDRH)
Reference: Notifications on Data Integrity – Medical Devices, FDA, content current as of 25 June 2026
MHRA Extends Annual Medical Device Registration Fee Deadline
On 26 June 2026, the Medicines and Healthcare products Regulatory Agency updated its guidance on registering medical devices to place on the market.
The update to the “Fees” section states that the annual fee payment deadline has been extended to 31 July 2026.
Guidance covers registration requirements for medical devices and IVDs placed on the Great Britain and Northern Ireland markets.
The extension gives registrants additional time to complete annual fee payments under the updated UK medical device registration fee structure.
Source: MHRA
Reference: Register medical devices to place on the market, MHRA, updated 26 June 2026
FDA Classifies Preeclampsia Prognostic Test into Class II
On 26 June 2026, the FDA published a final order classifying the prognostic test for development or progression of preeclampsia into class II with special controls.
The device type is an in vitro diagnostic device intended to measure one or more analytes from human samples as an aid in risk assessment for the development or progression of preeclampsia, but not for diagnosis.
Order was published and became effective on 26 June 2026. The underlying classification had been applicable since 18 May 2023.
The order codifies a class II classification and special-control framework for this IVD device category.
Source: FDA / Federal Register
Reference: Classification of the Prognostic Test for Development or Progression of Preeclampsia, FDA / Federal Register, 26 June 2026
European Commission Publishes EU HTA Flash Report from HTACG Meeting
On 24 June 2026, the European Commission published a flash report from the meeting of the Member State Coordination Group on Health Technology Assessment held on 22 June 2026. The meeting covered several aspects of ongoing implementation under Regulation (EU) 2021/2282 on health technology assessment, including joint clinical assessments, subgroup activities and the HTA IT Platform.
Of particular relevance for the medical device and IVD sectors, the HTACG adopted the first recommendation for the selection of medical devices and in vitro diagnostic devices for joint clinical assessment. The group recommended two implantable medical devices in the circulatory system area for selection.
The update provides context on the implementation of EU HTA procedures relevant to high-risk medical devices and IVDs, including the emerging process for selecting technologies for joint clinical assessment.
Source: European Commission
Reference: Flash report published: Member State Coordination Group meeting on 22 June 2026, European Commission, 24 June 2026
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