Is this product a medical device?
In the world of healthcare, patients and healthcare professionals rely on a vast array of equipment, but not everything they use is a medical device.
Don’t risk misclassification! Learn what makes a product a medical device using the MedDev Central 3-step MAP Framework:
Match • Analogues • Partners (Help)
Understanding what constitutes a medical device is important
- For innovators and manufacturers, it determines key aspects of product development and market access, including regulatory oversight, reimbursement pathways, and marketing, sales, and service obligations.
- For users, including healthcare professionals and providers, it ensures they are procuring and using the right products for the right purposes.
Misinterpreting whether a product is a medical device can lead to significant legal, financial, and reputational risks�“and, most importantly, it can harm users or patients.
Qualification - Determining whether a product meets the regulatory definition of a medical device
The basis for determining qualification is the product’s intended purpose. The intended purpose is a concise statement defining the use for which the product is intended according to the manufacturer’s claims. It can encompass prevention, diagnosis, monitoring, treatment, or support of disease, injury, or disability.
MedDev 101 introduces users to the proprietary MedDev Central MAP framework.
MAP is an easy, 3-step framework for mapping a product’s intended purpose to the definition of a medical device.
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Developed and taught by medical device experts and founders.
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The course follows the MedDev Central MAP framework for medical device qualification. MAP is an easy, 3-step framework for mapping a product’s intended purpose to the definition of a medical device: Match �" Analogues - Partners. Find the relevant formal definition of a medical device and compare it to the intended purpose. There are usually two main parts to formal medical device definitions: A product must meet both parts of the definition to be considered a medical device in that market (although there are exceptions in some regulatory systems). Identify similar products and examine whether they are considered medical devices. This information is included in the product’s labelling or can be found by searching regulatory authority databases. Suppose a product with the same intended purpose (known as a predicate device) was previously qualified as a medical device. In that case, that qualification likely applies to all products with that intended purpose in that market. Ask for help. Sometimes, a product’s medical device qualification is not obvious. These are called borderline cases. Stakeholders, such as regulators or payers, often provide guidance documents supporting borderline case determination. You can also research how previous borderline cases have been resolved. If the answer is still not clear, you may be able to request formal advice from the relevant authorities. Format: Self-paced online course Duration: 1-2 hours Course Materials: Dr. Sophie Laurenson, PhD / Executive MBA CEO and Founder, MedDev Central With a PhD in biophysics and bioengineering (Oncology) and two decades of hands-on industry experience, I’ve spent my career leading and shaping R&D programmes across the medical device sector. I’ve founded and supported several spin-out and startup companies, translating early scientific concepts into manufacturable and regulator-ready technologies. Beyond startups, I’ve worked and consulted for multiple multinational medical device and pharmaceutical companies, helping R&D and innovation teams design robust development pathways and build portfolios that can withstand real-world regulatory, technical, and commercial scrutiny. Price: FREE Includes: 12 months of access to course materials, downloadable qualification toolkit and certificate of completion. Need a custom package? We offer tailored solutions for large teams, academic institutions, and accelerators. Contact us to discuss enterprise licensing or co-branded delivery.Course Curriculum
M: Match = compare to definition
A: Analogues = find similar/predicate products
Partners = seek guidance or advice
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Ready to take the next step in mastering medical device qualification?
Enrol in our free course today and gain access to practical examples and comprehensive toolkits designed to simplify the qualification process.
