The first step of understanding the likely regulatory requirements is device classification. In all jurisdictions using the GHTF model of regulation, there are risk based classification rules, more or less identical to those first published in Annex IX of the European Medical Device Directive EC 93/42.
Getting the classification right is vital. The level of regulatory review applied – and the processes for regulatory approval – are contingent on the device class. It’s important to know what the class is so you can figure out the regulatory pathway.
Enter “Classify My Device” a handy smartphone App which makes it easy to apply the European rules. Using a simple Q&A process the app navigates the rule set for you to determine the class of your device. There’s context sensitive help, serving up all of the guidance and definitions you are likely to need along the way.
Need help sorting out your regulatory pathway? – Contact us for detailed advice. We can support strategy, submissions and postmarket compliance in Europe, the US and the Asia Pacific.
Email us at firstname.lastname@example.org or call +61 2 9906 2984