The UK Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance "Borderlines with Medical Devices & Other Products in Great Britain" which presents the MHRA’s current views on the interpretation of the medical devices legislation as it relates to borderline products.
The MHRA defines "borderlines" in the context of medical devices as products that have characteristics of both medical devices and other product types, such as cosmetics, biocides, or general consumer products.
These products may raise questions about whether they should be considered medical devices and therefore be subject to the regulatory requirements applicable to medical devices.
The MHRA's guidance on borderlines provides criteria and examples to help stakeholders determine the regulatory status of such products.
Key Elements of the Updated Guidance
Scope and Applicability: The updated guidance outlines the scope of products that may have borderlines with medical devices and provides examples of products that may fall into this category.
Classification and Categorization: It explains the classification of medical devices and how they are categorized based on their intended use and characteristics.
Criteria for Determining Borderlines: The guidance provides criteria for determining whether a product should be considered a medical device or fall into another product category, such as cosmetics or biocides.
Regulatory Requirements: It outlines the regulatory requirements for medical devices and other product categories, including compliance with standards and labeling requirements.
Case Studies and Examples: The updated guidance includes examples to help stakeholders understand how to apply the criteria for determining borderlines in practice.
Implications for Stakeholders
For stakeholders in the medical device industry, understanding and complying with the MHRA's updated guidance on borderlines is crucial to ensure that products meet the appropriate regulatory requirements. Failure to comply with these requirements could result in enforcement action by the MHRA.
The MHRA's updated guidance on borderlines with medical devices provides valuable information and guidance for stakeholders in the medical device industry. By understanding the criteria for determining borderlines and complying with regulatory requirements, stakeholders can ensure that their products meet the necessary standards for safety and efficacy.
Also, check out this guidance released on 10th April on "Notify the MHRA about a Clinical Investigation for Medical Devices" which will guide how to notify the MHRA of your intention to carry out a clinical investigation for medical devices.