Not every product fits neatly into one category, and when it doesn’t, IMed Consultancy is here to help. As experts in borderline products, we support manufacturers and innovators in defining, documenting, and defending the correct classification for their products under UK, EU, and international frameworks.
Our borderline product consultancy helps you determine whether your product qualifies as a borderline medical device, cosmetic, IVD, or medicinal product, and how to comply with the relevant regulations.
What Are Borderline Products?
Borderline products are those that sit between regulatory categories. For example, where it’s unclear whether a product is a medical device, cosmetic, medicinal product, or IVD. Uncertainty can cause major delays and compliance risks if the wrong pathway is chosen.
IMed Consultancy’s specialists work with you to interpret definitions under MHRA borderline product guidance, MDR, IVDR, and cosmetic regulations. We help you identify the product’s intended purpose, mode of action, and claims, ensuring your classification is correct from the start.
Expert Help with Medical Device Classification
Accurate medical device classification is critical to achieving and maintaining compliance. IMed Consultancy assesses your product’s function, risk class, and intended use to determine whether it falls within medical device, IVD, or cosmetic frameworks.
Our consultants prepare documentation and technical justifications that can withstand a regulator or Notified Body review. Whether you’re classifying a borderline medical device, updating claims, or expanding into new markets, IMed ensures your pathway is clear, compliant, and defensible.
We can help with:
When Borderline Becomes a Business Risk
Unclear product classification can delay your market entry, leading to enforcement risk, or wasting critical development capital preparing documentation for the wrong framework. IMed Consultancy’s team acts quickly to resolve uncertainty, working with your in-house teams or external partners to establish the right route to compliance and keep your commercial plans on track.
Our Borderline Products Expert
Caroline Timberlake
Caroline brings over 15 years of experience in the pharmaceutical and medical device industries, with deep expertise in regulatory affairs and quality assurance. At Imed, Caroline leads our consulting services, ensuring clients receive high-quality guidance and support as they navigate complex regulatory requirements.
Why Choose IMed for Borderline Product Consulting?
IMed Consultancy brings together specialists with backgrounds in regulatory affairs, quality assurance, and product development across medical devices, diagnostics, and cosmetics. We understand how regulators such as the MHRA assess and classify borderline products, and we help you position your product, evidence, and claims in line with the correct regulatory category.
We’re known for:
Frequently Asked Questions
Working with borderline products often raises difficult regulatory questions. Here are some of the most common queries our consultants answer.
A borderline product is one that could fall under more than one regulatory framework, like a skincare device that could be classed as a cosmetic or a borderline medical device. IMed helps you determine which framework applies and justifies your choice.
The MHRA borderline products guidance defines how to interpret whether a product is a medicine, medical device, or cosmetic in the UK. IMed uses this framework to help you classify and document your product accurately.
Yes. IMed Consultancy assists with the classification of cosmetics versus medical devices or medicines, ensuring your claims, ingredients, and labelling remain compliant under UK and EU regulations.
Correct medical device classification determines your entire regulatory pathway, including conformity assessment, technical documentation, and post-market obligations. IMed ensures your classification is evidence-based and regulator-ready.
As early as possible. Involving a borderline product consultancy during product design or claims development can prevent delays, rework, and compliance risks later in the process.
Ready to Clarify Your Product’s Classification?
IMed Consultancy helps companies resolve uncertainty, reduce risk, and accelerate compliance for borderline products. Whether your challenge involves a borderline medical device, classification of cosmetics, or an MHRA submission, our experts are ready to help.