The demand for medical devices in the UK has soared, prompting manufacturers to navigate complex classifications. While global acceptance is a factor, it doesn’t always align with the standards set by the MHRA. To ensure compliance, manufacturers must decode the UK’s specific classification criteria.
Certain products blur the line between medical devices and other categories like medicines, herbal products, cosmetics and more. These borderline products require MHRA’s expertise to determine their classification and associated risks.
This paper aims to provide clarity on distinguishing medical devices from borderline products, offering essential insights to help manufacturers make informed decisions.
Recently, on July 11th 2023, the MHRA introduced a crucial update to its guideline on Borderline products. This update includes a new section on ‘Risk classification of medical devices’, which outlines the risk-based classification system for medical devices. Depending on the risk level, devices are categorized into Class II, IIa, IIB, or III, with varying assessment requirements.
How to determine if your product is a medical device and its risk class:
Manufacturers facing uncertainty about their product’s medical device status can consult the MHRA. If a product complaint has arisen or regulatory compliance is in question, seeking MHRA’s guidance is essential. Additionally, assessing the risk classification becomes crucial if a product already on the market might have been misclassified.
The classification rules for general medical devices are outlined in the UK MDR 2002, specifically in Part II and Annex IX of Directive 93/43/EEC, as modified by Part 2 of Schedule 2A to the UK MDR 2002.
Still have questions?
MEDIcept can help! If your firm needs assistance in determining if your device is a borderline product or classifying your product with the UK, we are here to help. Contact us today at firstname.lastname@example.org.
When to seek advice?
If you need expert advice on whether your product qualifies as a medical device or falls under a specific risk class, you can reach out to the MHRA at Devices.Borderlines@mhra.gov.uk. Make sure to provide comprehensive details about the product, its intended purpose and its functionality.
👉🏾 Read more:
Borderline products: how to tell if your product is a medical device and which risk class applies – GOV.UK (www.gov.uk)
Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)
Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
Directive 93/42/EEC on medical devices (EU MDD)
Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)
Patricia Tolmos – Quality Systems Consultant