The week of 20–26 July 2026 brought several relevant regulatory developments in the medical device and in vitro diagnostic (IVD) sectors.
The main developments included new MDCG clarification on UDI responsibilities, an Italian Ministry of Health update on complaint reporting, WHO’s first interim list of medical device regulatory authorities, a new European AI quality-management standard, and an FDA Early Alert involving Boston Scientific ENROUTE Transcarotid Neuroprotection Systems.
In this issue
- MDCG clarifies UDI assignment between manufacturers and distributors
- Italian Ministry of Health Updates the Process for Reporting Medical Device and IVD Complaints
- WHO announces first interim list of medical device regulatory authorities
- EN 18286 introduces an AI quality-management framework
- FDA Issues Early Alert for Boston Scientific ENROUTE Transcarotid Neuroprotection Systems
MDCG Clarifies UDI Assignment between Manufacturers and Distributors
On 22 July 2026, the European Commission announced the publication of MDCG 2026-5, a position paper addressing UDI assignment where a distributor markets a device under its own brand name.
The document clarifies that two UDI-DIs may be assigned to the same device when it is placed on the market under two different trade names. However, the identifiers must be assigned by the manufacturer and linked to the manufacturer both in the EUDAMED UDI/device registration module and in the databases or internal documents of EU UDI issuing entities.
According to the MDCG, the manufacturer may delegate certain operational activities to a third party, such as interaction with UDI issuing entities, but ultimate legal responsibility for compliance with UDI obligations remains with the manufacturer.
The position paper provides useful clarification on UDI traceability where distributors market devices under their own brands.
Source: MDCG
Reference: MDCG 2026-5 — Position Paper: UDI assignment between manufacturers and distributors
Italian Ministry of Health Updates the Process for Reporting Medical Device and IVD Complaints
The Italian Ministry of Health published operational instructions for submitting complaints involving medical devices, products listed in Annex XVI to Regulation (EU) 2017/745, and in vitro diagnostic devices.
The communication concerns complaints submitted by healthcare professionals, lay users and patients, and provides operational instructions for submission through the Ministry’s online system.
From 22 July 2026, public or private healthcare professionals, healthcare facilities, pharmacies, general practitioners and paediatricians are required to report complaints to the Ministry of Health by completing the dedicated online form.
Complaint reports are acquired through the Ministry of Health’s new NSIS-Dispovigilance information system, and it is no longer necessary to submit complaints to the email inboxes of the Directorate’s offices.
The document also specifies that complaint reports must be submitted to the Ministry within 30 days from the date on which the healthcare professional became aware of the event or received the communication from lay users or patients.
The update concerns complaint reporting and should be distinguished from serious incident reporting under vigilance requirements.
Source: Italian Ministry of Health
Reference: Operational guidelines for the submission to the Ministry of Health of complaints concerning medical devices, products listed in Annex XVI to Regulation (EU) 2017/745, and in vitro diagnostic medical devices.
WHO Announces First Interim List of Medical Device Regulatory Authorities
On 23 July 2026, the World Health Organization announced its first interim list of regulatory authorities for medical devices, following the initial publication of the technical document on 14 July 2026.
Authorities included in the list are designated as transitional WHO Listed Authorities, or tWLAs.
The temporary arrangement recognises national and regional authorities with established regulatory performance while WHO completes its permanent evaluation pathway for medical devices.
The list is intended to support regulatory reliance and will be updated as authorities complete the full WLA assessment process.
Publication provides a new international reference point for regulatory cooperation and reliance in the medical device sector.
Source: WHO
Reference: List of transitional WLAs for medical devices
EN 18286:2026 – “Artificial intelligence — Quality management system for EU AI Act regulatory purposes”
On 22 July 2026, EN 18286:2026, “Artificial intelligence — Quality management system for EU AI Act regulatory purposes”, became available as a published European standard.
The standard specifies requirements and provides guidance for establishing, implementing and maintaining a quality-management system for organisations providing AI systems.
It is primarily intended for organisations placing high-risk AI systems on the market or putting them into service and is not specific to any particular sector.
The standard may therefore also be relevant to medical device organisations developing or supplying AI systems that fall within the EU AI Act’s high-risk provisions.
CEN database indicates that citation of the standard in the Official Journal of the European Union is expected.
Source: CEN
Reference: EN 18286:2026 — Artificial intelligence — Quality management system for EU AI Act regulatory purposes
FDA Issues Early Alert for Boston Scientific ENROUTE Transcarotid Neuroprotection Systems
On 24 July 2026, the FDA issued an Early Alert concerning specified lots of Boston Scientific’s ENROUTE Transcarotid Neuroprotection System and ENROUTE Transcarotid Neuroprotection System Plus.
The affected devices are being removed following reports of arterial sheath tip separation or partial separation during use.
Tip separation may require endovascular or surgical retrieval of the retained tip. Potential complications include embolism, stroke, transient ischemic attack, restenosis or thrombosis.
As of 9 July 2026, Boston Scientific had reported one serious injury and no deaths associated with the issue.
The alert concerns neuroprotection systems used during procedures involving the carotid artery, where device failure may lead to serious vascular or neurological complications.
Source: FDA – Center for Devices and Radiological Health (CDRH)
Reference: Early Alert: Percutaneous Catheter Issue from Boston Scientific
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