Is your product a medical device? Find out with Quick Scan
Determining whether a product is a medical device is a complex and time-consuming task. In fact, Article 2 of the EU’s Medical Device Regulation (MDR) defines a medical device with six different medical purposes – and over 70 related terms.
On top of that, there are borderline devices, and accessories – like foot switches and remote controls. Then there are devices that do not have an intended medical purpose, but still need to comply with the MDR. It seems nothing is straightforward.
To provide you a quick and easy way to experience the qualification process and to help qualify your own product as a medical device (or not) we’ve created a Quick Scan, which you can access here, for free.
On top of that, there are borderline devices, and accessories – like foot switches and remote controls. Then there are devices that do not have an intended medical purpose, but still need to comply with the MDR. It seems nothing is straightforward.
To provide you a quick and easy way to experience the qualification process and to help qualify your own product as a medical device (or not) we’ve created a Quick Scan, which you can access here, for free.
Why it matters
Under the MDR, how you define a product and its intended medical use is everything. Your definition determines the medical device status and also its risk class. Getting this right is essential for the type of certification process the Notified Body will apply and to gain access to the EU market.
Right now, Notified Bodies are certifying a backlog of medical devices. That’s because the MDR brings more devices into its scope and puts existing ones – such as Software as a Medical Device (SaMD) – into a higher risk class.
At the same time, other devices that sit on the borderline can benefit from being certified under the MDR. For example, a health and fitness product that gains certification as a medical device gains elevated status and more possibilities for reimbursement with a medical-grade qualification.
Where to find guidance
The EU’s Medical Device Regulation (MDR) is your starting point. It defines what constitutes a ‘medical device’ 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 [...] specific medical purposes.”
The EU’s Medical Device Coordination Group (MDCG) regularly updates the manual on borderline devices, which contains the latest information on borderline cases. Accessory devices – designed to be used in conjunction with a device with a medical purpose – are limited to their accessory function unless they attain medical device status. In the latter case, such accessories have their risk classification as per the MDR classification rules of Annex VIII.
Annex XVI of the MDR describes a listing of medical devices that do not have an intended medical purpose, but still need to comply with the MDR – typically cosmetic products like party contact lenses and dermal fillers. That’s because they have a risk profile comparable to their medically relevant counterparts.
How to get started with Quick Scan
Correctly qualifying a product – and classifying it – is a complex process that takes time and product understanding. Thankfully, with Peercode Regulatory Consultancy’s Quick Scan, you can get an expert answer including extra supportive information within 1 working day.
- You complete the form – it takes around 5 minutes
- Our regulatory experts assess your answers
- We email our findings within 1 working day
- You schedule a free call to discuss the results
Looking for expert guidance on correctly qualifying your device?