Currently, the European market is in the middle of a severe Covid19 crisis and in urgent need of Medical, In-Vitro Diagnostic-Devices and Personal Protective Equipment (PPE). You may already know that you have to comply with the CE marking requirements before you can start selling any of these kinds of equipment in the EU. The question is, which set of rules do you need to follow if you would like to enter the European market to help dealing with the COVID 19 situation?
First of all, it is important to establish classification of the products, as it determines the applicable compliance path. There is a possibility to regulate the protective products under the Medical Device Directive and/or the Personal Protective Equipment Directive (PPE).
The classification will be determined by the manufacturer’s intention for the product as defined in the labelling, instructions for use and promotional material and its mode of action in conjunction with the definition of a medical device/PPE as stated in the respective legislations. Who is going to use it? Is it going to be used in the medical context (eg. by doctors in the hospital) or for protection of the general public (out of the hospital setting)?
· If the product is intended to be used in a medical setting, i.e. hospital – unless the intended use will be clearly specified, a product will be likely to have a dual function, both medical (preventing disease) and protective; therefore, the product will be primarily classified as a medical device.
· If the product is intended to be used outside of a medical setting, to be used by the general public, then a product will be a typical personal protective equipment. An example would be a person wearing a mask when he goes outside of his house to protect himself from Covid-19;
When we are talking specifically about face masks, the following classification applies:
– Medical Devices Class I – if intended for medical procedures
– PPE – if intended for general use by non-professional users
– Medical Devices Class I & PPE I – if intended medical procedures to protect both the medical professional and the patient
To find out more about how Obelis can help in making sure your protective products are compliant, talk to our team of European regulatory and compliance experts. To get a quote on any of our services, contact Obelis today!