Are you a medical device manufacturer and your technical documentation is ready? You want to submit it now? Here you will find important information on this.
In order to bring a medical device to market, manufacturers must apply the applicable conformity assessment procedures to their medical devices. For the submission of the technical documentation, DQS Medizinprodukte GmbH has prepared an information based on the requirements of the (EU) 2017/745 Medical Devices Regulation (MDR) Annex II and Annex III.
More about submission of a technical documentation according to EC Regulation 2017/745:
- Administrative Information
- Technical Documentation