In the context of pre-submission meetings you are able to discuss with us as a Notified Body scientific or procedural aspects like the development and approval of medical devices. The applicant shall obtain the opportunity to discuss in detail queries relating to the process procedure as well as to the required contents of the submitted technical documentation.
A big plus for you: already during the development phase, you can check with our technical experts, whether the presented data for a particular aspect (e.g. clinic or safety innocuousness) of the technical documentation are sufficient in order to start a conformity assessment procedure for the medical device.
Therefore you do not only gain clarity but also time. Object of the pre-assessment in the development phase could, among other things be the following:
- Biological safety testing
- Safety innocuousness
- Benefit- risk assessment
- Risk Management
- Clinical Evaluation / Clinical Trials
- drug component
- Component of human plasma or stable blood derivatives
- Component of animal originated tissue or deadened derivatives
- Procedural issues
The Pre-Submission Meeting will be held at request and the request must be justified by the manufacturer. There will be no guideline for development programs provided by us as a Notified Body. Gather more details from our application form.