Do you manufacture reusable surgical instruments of class lr and would like to find out about the new legal requirements? Then we have something for you.
For the handling of reusable surgical instruments of class lr, DQS Medizinprodukte GmbH has prepared an information based on the requirements of the (EU) 2017/745 Medical Devices Regulation (MDR). This information covers definitions, general conditions, requirements for the quality management system and much more.
Learn more about reusable surgical instruments of class "Ir" according to MDR
- Classification rules
- Legal framework
- Conformity assessment procedures
- Requirements for the QMS
- Technical documentation