PharmacovigilanceOfficial

AEMPS device bulletin flags seven safety notices and two new MDCG documents for Q3 2026

🇪🇸 AEMPS · Fri 13 Nov 2026

Spain's regulator reports no legislative changes in July–September 2026, but lists a UDI position paper, an IVD classification guidance update and several patient-safety notes.

The Spanish Agency for Medicines and Medical Devices (AEMPS) published its Medical Devices Bulletin for July–September 2026 on 13 November. It states that there were no legislative updates in the period. The text available to us is cut off partway through the final safety notice, so this report covers only the items visible.

On implementation documents, the bulletin lists MDCG 2026-5, a position paper on UDI assignment between manufacturers and distributors. It addresses the assignment and registration of UDI-DIs where one device is marketed under both the manufacturer's brand and a distributor's brand, aiming to prevent divergent interpretations among manufacturers, distributors and EU UDI issuing entities.

The bulletin also notes revision 5 of MDCG 2020-16, the guidance on classification rules for in vitro diagnostic devices. Rule 7 has been revised to clarify the rationale for classifying control materials without assigned qualitative or quantitative values, and states that a manufacturer may give information on the presence or concentration range of analytes without this necessarily counting as assigned values. The update also clarifies the purpose of independent quality control materials and how they differ from controls intended to verify the performance of the IVD itself.

The vigilance section summarises AEMPS information notes issued to patients and the public. Winncare's Winn'Motion patient transfer hoists (note 29/2026, 16 July) may suffer detachment of the hanger or suspension bar owing to a mispositioned safety-nut pin, risking a patient fall. Medtronic's MiniMed Go diabetes app (30/2026, 7 July) has an issue with the 'Adjust day and night' option that could stop some night-time alerts activating correctly. Dexcom reported the theft and illegal sale of two G7 sensor lots, 1725204004 and 1725069002, which had been selected for withdrawal and destruction for failing internal quality controls (31/2026, 17 July).

Baxter's HomeChoice personal cycler sets with cassette and four lines (33/2026, 22 July) are linked to more alarms in certain lots, chiefly 'Revisión de líneas y bolsas' and 'Reposicione cassette 156'. Repeated alarms could stop a therapy cycle starting and delay or interrupt treatment, and raise contamination risk if aseptic technique is not followed. ResMed's Astral 100 and 150 ventilators (35/2026, 5 August) may stop delivering therapy because a supercapacitor can leak electrolytes and damage parts of the PCBA, sending the device into a safe state. Hollister's Onli hydrophilic intermittent urethral catheters (36/2026, 27 August) may have a manufacturing-defect protuberance about 2 cm from the drainage eye, potentially causing discomfort, genitourinary trauma or bleeding. A note on Dynavox TD Navio Midi and Maxi communication devices (37/2026, 27 August) concerns the mechanical strength of the internal battery structure; the source text ends before further detail.

What it means for your team

  • Manufacturers and distributors using private-label arrangements should read MDCG 2026-5 against their current UDI-DI assignment and registration practices.
  • IVD manufacturers with control materials should check their Rule 7 classification rationale against the revised MDCG 2020-16 (rev. 5).
  • Vigilance teams should compare the listed notices with their own field safety corrective action records and distributor or user communications in Spain.
  • The bulletin text provided is truncated, so the full AEMPS notes should be checked for complete details, including the Dynavox item.

Official source: AEMPS ↗

Article written by VigiEye from the official source (AEMPS). AI-assisted; check the source before acting.

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