The week of 6–12 July 2026 brought several relevant regulatory and standards updates in the medical device and in vitro diagnostic (IVD) sectors.
The main developments included a Council of Europe position paper on MDR implications for the substances of human origin sector, the opening of FDA’s MDUFA VI public meeting and comment process, updated Swissmedic guidance on IVD performance studies, a Class I recall involving Ivenix infusion pumps, and the start of a new ISO project to revise the guidance supporting application of ISO 14971.
Council of Europe Publishes a follow-up Position Paper on the implementation of the MDR in the substances of human origin sector
The European Committee on Organs, Tissues and Cells, coordinated by the EDQM, published a follow-up position paper examining the implications of the MDR for the substances of human origin sector.
The paper addresses devices used by SoHO establishments, including research-use-only products deployed for medical purposes and CE-marked devices used outside the manufacturer-defined intended purpose.
It also calls for further clarification on how MDR Article 5(5) and related MDCG guidance apply in these settings.
The publication provides institutional context on the interaction between MDR requirements and specialised healthcare activities involving organs, tissues and cells.
Source: Council of Europe / EDQM
Reference: Medical Devices Regulation and its Implications for the Substances of Human Origin Sector, Council of Europe / EDQM, 8 July 2026
FDA Announces the Opening of the Public Meeting and Comment Process for “Medical Device User Fee Amendments (MDUFA VI)”
The U.S. Food and Drug Administration announced a public meeting to discuss proposed recommendations for the next Medical Device User Fee Amendments reauthorization cycle, beginning in fiscal year 2028.
The hybrid meeting is scheduled for 5 August 2026.
The public docket opened on 7 July 2026 and includes the proposed commitment letter. FDA will receive written comments until 6 August 2026, while the current MDUFA legislative authority expires on 30 September 2027.
The notice marks a formal public stage in the development of the next U.S. medical device user-fee program.
Source: FDA – Center for Devices and Radiological Health (CDRH) / Federal Register
Reference: Medical Device User Fee Amendments 2028 (MDUFA VI) / Medical Device User Fee Amendments; Public Meeting; Request for Comments, FDA / Federal Register, July 2026
Swissmedic Updates Information Sheet on Performance Studies with IVDs
On 8 July 2026, Swissmedic updated its English information sheet on performance studies with IVDs.
The information sheet provides guidance on the approval process, sponsor reporting requirements and Swissmedic surveillance for IVD performance studies in Switzerland.
The update consolidates current Swissmedic procedural information for the conduct and oversight of IVD performance studies.
Source: Swissmedic
Reference: BW600_00_016e_MB Performance studies with IVD, Swissmedic, updated 8 July 2026
FDA Identifies Ivenix Large Volume Infusion Pump Corrections as Class I Recall
The FDA identified a Class I recall, the most serious type, involving Fresenius Kabi Ivenix Large Volume Infusion Pumps that have been dropped or severely jarred.
According to the FDA, these impacts can loosen the touchscreen input cable, leading to unintended screen behaviours or unresponsiveness, which may interrupt or delay therapy.
The issue can lead to adverse health consequences, including serious injury or death. As of 6 May 2026, Fresenius Kabi had reported two serious injuries associated with the issue.
Source: FDA – Center for Devices and Radiological Health (CDRH)
Reference: Infusion Pump Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Infusion Pump and Infusion Pump Correction: Fresenius Kabi Issues Correction for Dropped or Jarred Ivenix Large Volume Infusion Pumps, FDA, 7 July 2026
ISO Starts Revision of ISO/TR 24971:2020 and Registers New ISO/TS 24971-1 Project
ISO moved ISO/TR 24971:2020, the companion guidance document for ISO 14971 risk management, to the “to be revised” stage on 6 July 2026.
The ISO catalogue also lists ISO/AWI TS 24971-1 as the document under development that is expected to replace the current technical report.
ISO/TR 24971:2020 currently provides guidance on the development, implementation and maintenance of a medical-device risk management system in accordance with ISO 14971:2019.
The new work item is at an early development stage, and no final publication date is yet indicated.
The project signals a planned restructuring and revision of the main ISO guidance supporting application of ISO 14971.
Source: ISO – International Organization for Standardization
Reference: ISO/TR 24971:2020 — Medical devices — Guidance on the application of ISO 14971 and ISO/AWI TS 24971-1, ISO, revision stage recorded 6 July 2026
Share this article
Subscribe to MDN
Subscribers receive each new issue by email every Monday, one week before it is published on the website.
Related posts
The content is provided for informational purposes only and does not constitute regulatory, legal or professional advice. For complete and up-to-date information, refer to the original official communications, the cited sources and the applicable documentation.
MDN Archive and News Collection
Browse all published MDN issues in the MDN Archive or search individual news items in the News Collection.