MHRA Requires Quarantine of Medical Devices Without Valid UKCA/CE Conformity Markings in August 2026; Six Product Categories Named

MHRA Requires Quarantine of Medical Devices Without Valid UKCA/CE Conformity Markings, Six Product Categories Named

Published: September 29, 2026, 19:30 Category: Registration and Market Access

Full Translated Core Content

On August 10, 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) issued a news release and simultaneously published Device Safety Information DSI/2026/007, Devices supplied without valid UKCA/CE conformity markings or certification: remove from use and place in quarantine.

The document addresses a group of medical devices that have entered the UK market but lack valid conformity markings and certification support. MHRA requires healthcare institutions to immediately stop using and supplying them, place remaining stock in quarantine, and switch to compliant alternatives. Distributors are required to stop further supply and cooperate with traceability.

Six Product Categories Named

• VAKU-8 Blood Collection / Infusion / Scalp Vein Set — manufacturer: Hindustan Syringes & Medical Devices Ltd
• Bipson's Gauze Swab Sterile — manufacturer: Bipson Surgical Private Ltd
• Technocut Scalpel — manufacturer: Niraj Industries Ltd
• Romsons Alco Swabs — manufacturer: Romsons Group Private Ltd
• Medi Grip Adhesive Bandage (Antiseptic) — manufacturer: Precision Coatings (P) Ltd
• Bone Marrow Biopsy Needle — manufacturer: Meditech Devices Pvt. Ltd

According to DSI/2026/007, the clinical uses of these products cover blood collection and infusion, surgical and biopsy procedures, wound management, and skin preparation/antisepsis.

Compliance Issue, Not a Product Safety Signal

MHRA explicitly states that it has not identified specific defects, performance problems, quality issues, or safety signals in these products. The reason for action is not that the products are defective, but that they have not completed the conformity assessment and certification required for supply in the UK market. Without valid UKCA or CE certification support, conformity assessment, quality management system, safety, sterility, and performance cannot be fully assured. This distinction is important for companies assessing the nature of the risk: this is a market access and compliance issue, not a product safety event.

Legal Basis

The legal basis is set out in the DSI: the UK Medical Device Regulations 2002 and EU Regulation (EU) 2017/745 on medical devices. Lawful supply of medical devices in the UK market requires corresponding conformity markings and supporting certification. Because the devices concerned do not meet this condition, MHRA's action is quarantine and removal from use rather than a defect warning.

Requirements for Healthcare Institutions

The requirements for healthcare institutions can be summarized in five steps:

• Check whether the institution holds, uses, or supplies any product named in the DSI list.
• Immediately stop use and supply, and quarantine all remaining stock.
• Identify and use compliant alternative products.
• Retain affected devices until MHRA provides further advice.
• Notify MHRA at devices.compliance@mhra.gov.uk and cite the DSI number DSI/2026/007.

The document also requires institutions to ensure that relevant staff receive the DSI and understand the issue and the actions to be taken.

Requirements for Distributors

Requirements for distributors are more detailed:

• Identify affected devices that they hold or control.
• Stop further supply.
• If they have received, supplied, or distributed the relevant products, immediately notify MHRA via the same email address and provide known downstream distribution information, citing DSI/2026/007.
• Assist MHRA with traceability as required.
• Keep records of supply of affected devices to customers.
• Notify customers that may have received affected stock.

In other words, responsibility does not rest only at the product source; record-keeping and notification obligations at the channel level are separately specified.

Reporting Pathways

Healthcare professionals who suspect or confirm that a relevant device has caused an adverse event should report through existing regional channels:

• England and Wales: the Yellow Card scheme or the Yellow Card app.
• Scotland: the Incident Reporting & Investigation Centre (IRIC) and local incident recording systems.
• Northern Ireland: the Yellow Card website and the institution's medical device policy.

The DSI also states that there is no specific advice for healthcare professionals to communicate to patients in this matter.

Scope and Boundaries

The scope of application is worth emphasizing. This list concerns specific enforcement action against specific products and specific manufacturers. It should not be extrapolated to mean that all similar products are non-compliant, nor does it constitute a judgment on any company or product outside the list. On the other hand, the fact that MHRA has not identified a safety signal does not mean the relevant products can continue to be used. Until conformity markings and certification are completed, quarantine and removal from use are the actions explicitly required by the document.

Sources and Verification Notes

Sources: MHRA news release, MHRA advises quarantine of medical devices supplied without appropriate conformity markings, published August 10, 2026: https://www.gov.uk/government/news/mhra-advises-quarantine-of-medical-devices-supplied-without-appropriate-conformity-markings; MHRA Device Safety Information DSI/2026/007, Devices supplied without valid UKCA/CE conformity markings or certification: remove from use and place in quarantine: https://www.gov.uk/drug-device-alerts/devices-supplied-without-valid-ukca-slash-ce-conformity-markings-or-certification-remove-from-use-and-place-in-quarantine-dsi-slash-2026-slash-007. The legal basis referred to in the article is the UK Medical Device Regulations 2002 and EU Regulation (EU) 2017/745 on medical devices, available at https://www.legislation.gov.uk/uksi/2002/618/contents and https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng.

Verification scope and access date: The review covered the MHRA news release page, the text of DSI/2026/007 (including the Summary, Advice for Healthcare Professionals, Advice for Distributors, Explanation of identified safety issue, and Reporting advice sections), and the official text entries for UK MDR 2002 and EU MDR 2017/745. Access date: September 29, 2026. Affected product names, manufacturer names, the number of product categories, required actions, and reporting channels are taken from the above official pages.

Applicability note: This article is an interpretation of public information from the UK regulator and does not constitute a conclusion or commitment regarding any specific product, company, or registration application. It also does not indicate that products outside the list have problems. Actual compliance determinations should be based on the official MHRA text and subsequent updates; relevant information may change with further official publications.

Information sources: Medicines and Healthcare products Regulatory Agency (MHRA) - GOV.UK news, August 10, 2026; MHRA Device Safety Information (DSI/2026/007) - GOV.UK; UK Medical Device Regulations 2002 (legislation.gov.uk); Regulation (EU) 2017/745 on medical devices (EUR-Lex).

AIMEILI Regulatory Interpretation

For global medical device manufacturers, distributors, CROs, and regulatory affairs teams, DSI/2026/007 is primarily an enforcement action on UK market access compliance rather than a product safety alert. The key regulatory issue is that the devices were placed on the UK market without valid UKCA or CE conformity markings and the certification support required under the applicable UK and EU frameworks. MHRA has not identified a safety signal, but the absence of a safety signal does not cure the compliance gap.

Key Regulatory Takeaways

• Market access depends on valid conformity markings and certification: Manufacturers must verify that each device intended for the UK market has the correct UKCA or CE marking and supporting certification, as applicable, before placing it on the market.
• Compliance evidence must be complete: The DSI refers to conformity assessment, quality management system, safety, sterility, and performance. Regulatory affairs teams should ensure technical documentation and certification are available and current.
• Distributor obligations are enforceable: Distributors must identify affected stock, stop supply, notify MHRA, assist traceability, retain customer supply records, and notify downstream customers.
• Healthcare institutions must act immediately: Providers must screen inventory, stop use and supply, quarantine stock, and source compliant alternatives.
• The action is product- and manufacturer-specific: It does not automatically classify all similar products as non-compliant, but companies in the same categories should review their own compliance status.

Business Impact

• Supply disruption: Named products may be removed from UK clinical use and distribution, creating immediate demand for compliant alternatives.
• Inventory and traceability burden: Manufacturers and distributors may need to perform targeted stock checks, quarantine, customer notifications, and downstream traceability.
• Regulatory and reputational risk: Companies supplying similar products should confirm that UKCA/CE markings, certificates, declarations, and technical documentation are valid and aligned with UK requirements.
• Contractual and channel risk: Distributors and importers should review supplier qualification, conformity documentation, change control, and contract clauses covering regulatory non-compliance.
• Operational readiness: Regulatory affairs, quality, and supply chain teams should maintain procedures for rapid inventory holds, regulatory notifications, and alternative product sourcing.
• Strategic planning: Manufacturers should assess UK market access strategy, UK Responsible Person arrangements, UKCA/CE transition issues, and post-market surveillance obligations to avoid similar enforcement outcomes.

AIMEILI Recommendation

Manufacturers and distributors with products in the affected clinical categories should conduct a gap assessment against UK MDR 2002 and, where applicable, EU MDR 2017/745. Regulatory affairs teams should verify conformity marking, certification status, technical documentation, and traceability records. Where gaps are identified, companies should suspend further UK supply until compliance is confirmed and seek regulatory advice on corrective actions. Healthcare institutions should implement the five-step quarantine and notification process set out in DSI/2026/007.