EU: Publications from the National Working Group for Implementing the MDR and IVDR (NAKI)
The national working group for implementing the European regulations for medical devices (2017/745 MDR) and in-vitro diagnostics (2017/746 IVDR) has published information relating to the sub-groups involved and the current status of the discussions on the website of the Federal Ministry of Health.
This includes reports, presentations and FAQs relating to issues such as transitional provisions, notified bodies, manufacturer's obligations, classification, vigilance, clinical evaluation and processing. The documents provide an update on the progress of the processing and outstanding questions.