Class I Medical Device EU Registration : If a manufacturer plans to market their product in the EU market, the manufacturer has to ensure their product complies with the relevant European Directives set by the European Commission. Medical Devices are classified into 4 classes under EU framework – Classs I, IIa, IIb and III.
Non-invasive Class I devices do not need to provide proof to Notified body of compliance to CE directives as they are the lowest risk category. If the Product is Non-Sterile and or Non-Measuring then the manufacturer can self-certify via a written statement. If the product is marketed as sterile or measuring then it requires a Notified Body assessment.