MDN #003: Week 18–24 May 2026

The European Commission highlighted new requirements for conformity assessment activities carried out by notified bodies, while FDA published multiple recalls and potentially high-risk device issues. In Italy, the Ministry of Health issued an updated operational communication on serious incident report transmission through Dispovigilance.

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European Commission highlights Implementing Regulation (EU) 2026/977 on conformity assessment activities carried out by notified bodies

Area: Europe
Source: European Commission (DG SANTE)
Document type: Update / Institutional communication

The European Commission published an eNews communication summarising Implementing Regulation (EU) 2026/977, published in the Official Journal of the European Union on 5 May 2026. The Regulation sets out uniform requirements for conformity assessment activities carried out by notified bodies under the MDR and IVDR.

The communication highlights requirements concerning quotations to manufacturers, maximum timelines and “clock-stops” for key stages of conformity assessment, and annual publication of information on timelines and costs. The Regulation will apply from 25 February 2027, while the annual reporting requirement will apply from 1 January 2028.

Reference: Medical Devices: New Implementing Regulation sets out uniform requirements for conformity assessment and notified bodies

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Italy issues updated operational communication on MIR 7.3.1 submissions through Dispovigilance

Area: Italy
Source: Ministero della Salute (DGDMF)
Document type: Circular / Update

On 22 May 2026, the Italian Ministry of Health published an updated circular on the transmission of serious incident reports using MIR Form 7.3.1 through the national Dispovigilance platform.

The Ministry states that the platform has been adjusted to facilitate submissions using MIR Form 7.3.1 versions different from SB 11010. The circular also reiterates that, from 1 May 2026, economic operators must submit serious incident reports through Dispovigilance, pending full functionality of the EUDAMED vigilance module.

Reference: Ulteriori indicazioni operative… Decorrenza, dal 1° maggio, dell’obbligo di trasmissione dei MIR Form 7.3.1 tramite la piattaforma Dispovigilance – AGGIORNAMENTO

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FDA Early Alert: Abiomed Automated Impella Controllers affected by software restart issue

Area: United States
Source: FDA (CDRH)
Document type: Early Alert

The FDA issued an Early Alert, with content current as of 21 May 2026, concerning an issue involving Abiomed Automated Impella Controllers (AIC). The alert refers to an Urgent Medical Device Recall (Correction) notice containing updated instructions for use. According to the FDA, a software error may cause the AIC to restart when used in conjunction with left ventricular Impella devices.

Reference: Early Alert: Heart Pump Controller Issue from Abiomed

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FDA recall: React Health VOCSN V+Pro ventilators

Area: United States
Source: FDA (CDRH)
Document type: Recall

The FDA published a recall communication concerning certain VOCSN V+Pro ventilators manufactured by Ventec, doing business as React Health. The FDA identified the recall as the most serious type and stated that the affected devices should be removed from where they are used or sold.

The recall relates to a manufacturing process deviation that may result in an undetected oxygen leak condition. According to the FDA, this may lead to out-of-specification FiO₂ delivery before or during ventilation and may also increase the risk of fire in oxygen-enriched environments.

Reference: Ventilator Recall: React Health Removes VOCSN V+Pro Ventilators

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FDA Class I recall update: Bolton Medical Relay Pro thoracic stent graft system

Area: United States
Source: FDA (CDRH)
Document type: Recall (updated posting)

FDA updated its communication concerning the Relay Pro Thoracic Stent Graft System, N4 non-bare stent configuration, 32 mm and above. FDA states that Bolton Medical issued an Urgent Medical Device Recall (Correction) notice providing updated use instructions and recommending consideration of alternative stent-graft options before using affected devices.

The issue may prevent the graft from unclasping from the delivery system during the procedure. FDA states that this failure may lead to procedural delay, stent graft displacement, conversion to open surgical repair or death.

Reference: Thoracic Stent Graft Recall: Bolton Medical Removes Relay Pro System