PV Bulletin

Borderline products: medical devices and other products

Updated guidance from the MHRA clarifying the classification of products as medical devices versus medicinal products, affecting safety reporting frameworks.

Primary source: Medicines and Healthcare products Regulatory Agency (MHRA)

PV Impact Brief

Urgency: HighConfidence: high

What changed

Refined classification criteria for determining whether a product falls under Medical Device Regulations or Human Medicines Regulations, particularly affecting alcohol-only pre-injection swabs and wipes.

Why it matters

Accurate classification ensures compliance with the correct reporting frameworks, thereby enhancing safety monitoring and regulatory adherence.

Action needed

Organizations must update their adverse event reporting processes to align with the clarified classification of borderline products effective immediately.

Relevant for
Regulatory Intelligence LeadQPPV
Processes impacted
Country ComplianceICSR
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Policy change details

Document type
Guidance
Policy status
revised
Publication date
2026-06-29
Policy change
Updated guidance from the MHRA on the classification of products as medical devices versus medicinal products, clarifying the boundary between regulatory frameworks.

Key changes

Refinement of criteria used to distinguish between products regulated under Medical Device Regulations 2002 and those under Human Medicines Regulations 2012.

Affected workflows

Country ComplianceICSR

Responsible groups

Regulatory AffairsPV OperationsLegal

PV impact

Classification determines the applicable safety reporting framework (MDR vs. GVP). Changes or clarifications in classification affect which adverse event reporting rules and workflows apply to specific 'borderline' products.

View regulator source

Source document details

Exact policy details

Regulation Applicability
This guidance applies to products placed on the market in Great Britain (England, Wales, and Scotland).
Applies to: Great Britain (England, Wales and Scotland)
This guidance explains when a product would be considered a medical device within the terms of Part II of the Medical Device Regulations 2002. · p. 1 · High · Source
Last Update Date
29 June 2026
Applies to: Last updated date for the document.
Last updated 29 June 2026 · p. 1 · High · Source
Alcohol-only Pre-injection Swabs Regulation
Alcohol-only pre-injection swabs and wipes are considered to be medical devices.
Applies to: Specific product classification under medical device regulations.
Alcohol-only pre-injection swabs and wipes are considered to be medical devices. · p. 1 · High · Source

Extracted documents

Evidence and confidence

Confidence: highSource updated: Jun 29, 2026

Full briefing

Practical implication

Organizations must update their adverse event reporting processes to align with the clarified classification of borderline products effective immediately.

The MHRA has refined criteria for distinguishing between medical devices and medicinal products, particularly affecting the classification of borderline products like alcohol-only pre-injection swabs and wipes. This clarification impacts the applicable safety reporting frameworks (MDR vs. GVP) for adverse event reporting.

What changed: Refined classification criteria for determining whether a product falls under Medical Device Regulations or Human Medicines Regulations, particularly affecting alcohol-only pre-injection swabs and wipes.

Why it matters: Accurate classification ensures compliance with the correct reporting frameworks, thereby enhancing safety monitoring and regulatory adherence.

Practical implication: Organizations must update their adverse event reporting processes to align with the clarified classification of borderline products effective immediately.

View original source

Published from the Firecrawl policy change extraction pipeline.

#Safety Signals#Medicines and Healthcare products Regulatory Agency (MHRA)#Reporting Requirement#revised#policy-change#Guidance#firecrawl-policy-agent

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