A medical device always consists of the medical appliance AND its product file. Regardless of the device classification, whether you want to launch a class I, IIa, IIb, or III medical device or in vitro diagnostics: You must provide technical documentation in any case.The technical documentation includes all details about the medical device. In addition to the actual technical product information, it also includes all specifications about development, manufacturing, verification and validation, as well as application of the product.By means of the technical documentation, you as the manufacturer establish proof that your medical device conforms to the underlying regulations of the individual countries. Furthermore, it confirms compliance with the basic requirements for European CE marking. It is the prerequisite for the approval of a device in the relevant target country. Across the entire lifecycle of the device, but at least five years after the last device’s manufacture (15 years for implants), the technical documentation must be available to the supervisory authorities for inspection.
Classification of IVDs
According to IVDR, the classification rules are to be applied to the classification of in vitro diagnostics just as for medical devices. Depending on the classification, different requirements must be met in terms of the conformity assessment procedure and the involvement of the notified body. →More about IVDR
Keep track of everything: Your MDR schedule
Between directive and medical device regulation (MDR):
What do you need to do?
Some may think that three years is a long time; others are rather at a loss with all the work ahead. In fact, it remains to be seen how the notified bodies will interpret the changes of the new European medical device regulation to be able to derive detailed instructions. Nevertheless: There is a lot to do.Because in order to get all product files MDR-ready within the short transition period, considerable preparation is required: On the one hand manufacturers of numerous different devices will have to develop a useful strategy fast for bundling them into device groups. On the other hand – regardless of the number of devices – it is now important to update all existing product files in accordance with the medical device directive as this is the prerequisite for lifting them to MDR level by 2020.
Do not lose sight of your target!
Already while creating the technical documentation you should take into account possibly different requirements of different target markets. That way documents and their contents may be developed and structured in a way that they may be used for as many submissions as possible.Commission us to provide the documentation and we will start working on it promptly. We hardly need any time to familiarize ourselves with the topic, because we are already familiar with it. With our wide range of expertise, we know the regulatory requirements back to front and make sure that they are adhered to in your documentation. The result: finalized documents ready to be signed using your templates.