How do you know if your product is a “medical device”?

If you manufacture, distribute or have had an idea for a product or software in the health field, you should know whether it is a medical device.

Given the large number of definitions in circulation, it is worth considering the one offered by the Spanish Agency for Medicines and Health Products, according to which:

A medical device is any instrument, device, equipment, software, implant, reagent, material or other article intended by the manufacturer to be used, separately or in combination, for any of the following specific medical purposes in human beings:

  • diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease,
  • diagnosis, follow-up, treatment, relief or compensation for an injury or disability,
  • investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
  • information obtained by in vitro examination of samples derived from the human body, including organ, blood and tissue donations, and which does not exert its intended primary action within or on the surface of the human body by pharmacological, immunological or metabolic mechanisms, but to whose function such mechanisms may contribute.

In addition, they will also be considered as medical devices:

  • products to control or support conception,
  • products intended specifically for the cleaning, disinfection or sterilisation of medical devices

Why is it important to know if I am marketing a medical device?

Mainly because, in Spain, a medical device must be marketed under a licence issued by the Spanish Agency for Medicines and Medical Devices, for which a series of technical documentation describing its functioning must be gathered.

In addition, it is common for manufacturers to want to market their products in the EU, for which they must have the CE marking. In this case, there are two regulations: MDR 2017/745 for medical devices (including implantable actives) in May 2021, and IVDR 2017/746 in May 2022 for in vitro diagnostic medical devices.

Both regulations describe the general safety and performance requirements that medical devices must meet in order to be sold in the EU under this marking.

So if you are developing an idea that falls within the definition of a medical device and would not be used forin vitro diagnostics, we recommend that you pay attention to the requirements of MDR 2017/745.

In summary: The first thing to do is to check that your product falls within the AEMPS definition for medical devices and prepare the necessary documentation to obtain the licence. Next, it is necessary to study the requirements to be fulfilled in order to obtain the CE marking in the current regulations.

From Episkey Medical Consulting, we guide you step by step through these processes so that your product has all the documentation ready to be put on the market.



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