A dilemma of many general wellness product companies

Background 

A medical and wellness device manufacturer wanted to launch one of its devices, in the form of a wearable, that records, stores, analyses, and transfers single-channel electrocardiogram (ECG). The device utilized certain algorithms available through apps on Apple iOS and Google Android-based smartphones to analyze the single-channel ECG. Since wearables can be broadly classified as consumer general wellness devices (e.g., health and fitness trackers) the manufacturer was unsure whether their wearable meets the definition of a medical device, hence they sought Elexes’ expertise to understand the differences between the general wellness and regulated medical devices, in addition to obtaining a CE Mark for their wearable device. 

Challenge

The Client did not know if their product was a “medical device” and hence was not sure about what pathways should be followed to obtain a CE marking to access the EU market. 

Solution

Elexes’s Product Team that specializes in medical device standards and testing assessed the device taking into consideration the following elements:

1. Intended use of the product
2. Indications for use 
3. Product functionalities
4. Specific clinical application
5. Format of report 
6. Claims that the Company intends to make

The Product Team asked several questions as shown in the image below. Based on the due diligence, various responses, alerts and notifications generated by the device and the claims that the Company was interested in making it was determined that the device is a medical device. 

Once it was determined that the product was in fact a medical device, Elexes worked with the Company to lay out a path for CE Marking and worked from the start until the time a CE was obtained. 

Results

With Elexes by their side in an Advisory capacity the Company could quickly conclude that they were a medical device and why. Soon after they were able to pursue CE along with mandatory ISO certification and hence get the product to the EU market. The company was able to keep all the stakeholders happy and grow rapidly into new geographies. 

Key Takeaway

It has always been a debate whether or not a wearable can be considered as a medical device. This is a very tricky question and needs to be thought through very well. Assessing and concluding this early on goes a long way in pursuing the right steps at the right time.