Demystifying Regulatory Pathways for Entrepreneurs
Zahra Mavajian
Regulatory affairs and Quality assurance consultant – GBA Key2Compliance
Are you an entrepreneur with great ideas to impact your field, whether through a new device, software, service, or system? If so, you might be wondering: Does my innovation fall under Medical Device Regulation? And more importantly, what happens if it does?
Many innovators hesitate to reach out to regulatory specialists early in the development process. Some fear that involving regulatory affairs or quality assurance experts will slow down progress or even halt their project altogether. But this perception is not true, which I want to demystify.
Regulatory Experts: Your Strategic Partners, Not Gatekeepers
The role of a regulatory specialist is not to stop innovation, but to guide it!
When engaged early, they help you define your product in a way that aligns with regulatory expectations. This includes shaping the so called, intended use of your device or service, which is a cornerstone of regulatory classification.
In many cases, innovators discover that their product does not qualify as a medical device or in-vitro diagnostic (IVD) product under EU regulations, when they discuss the aim of the device with a regulatory expert.
So, What Is a Medical Device?
According to EU MDR 2017/745, a medical device is defined as:
“Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
- Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
- Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
- Providing information by means of in vitro examination of specimens derived from the human body, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, but may be assisted in its function by such means.” [1]
Similarly, EU IVDR 2017/746 defines an in-vitro diagnostic medical device as:
“Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body, including blood and tissue donations, solely or principally for the purpose of providing information on:
- A physiological or pathological process or state,
- Congenital physical or mental impairments,
- Predisposition to a medical condition or a disease,
- Determining the safety and compatibility with potential recipients,
- Predicting treatment response or reactions,
- Defining or monitoring therapeutic measures.” [2]
Why Early Regulatory Consultation Matters
By consulting a regulatory expert early, you gain clarity on:
- Whether your product qualifies as a medical device or not
- How to define the intended use correct and complete
- What regulatory pathway best suits the product and market goals
This proactive approach can save you time, resources, and unnecessary stress in later stages.
Bottom Line: Better Safe Than Sorry
Regulatory consultants are here to help, not hinder. They are your big support in navigating complex compliance landscapes and ensuring your innovation reaches the market safely and successfully.
Involving a regulatory specialist early in the design and development process is widely recognized as a key success factor for medical device innovation. Industry experience shows that early regulatory engagement helps clarify product classification, define intended use, and establish the right regulatory pathway, saving significant time and resources. For example, distinguish whether a digital health app would be classified as a general wellness product or a regulated medical device, avoiding unintended MDR obligations and costly redesigns!
Remember, it is the intended use you define for your device that determines whether the device is a medical device, an IVD device, or not a medical device at all. But how should you know? Don’t worry, we are here to help! If you’re developing something new and exciting, don’t wait. Reach out to a regulatory specialist and start the conversation. You might be surprised by how empowering it can be!
Download our “Road to CE‑mark” guide below, and send your questions to us through our website form or LinkedIn!
References
Want to learn more about the road to CE-mark for your medical device?
The CE mark indicates that a product meets the applicable EU laws and allows the manufacturer to make their device available on the European market. Navigate the complexities of obtaining a CE mark for your medical device with our guide.
Download our guide and start your road to CE mark!