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What to do with reusable surgical instruments of class "Ir" under the MDR?

Michael Bothe

Michael Bothe is head of the certification decision board for Active Medical Devices and is responsible for the legally regulated procedures.
May 05 , 2022
# CE marking

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.

medizin-home-dqs-technologie im krankenhaus mit medizinern im hintergrund

Learn more about reusable surgical instruments of class "Ir" according to MDR

  • Definition
  • Classification rules
  • Legal framework
  • Conformity assessment procedures
  • Requirements for the QMS
  • Technical documentation
Get informed now!
Author
Michael Bothe

Michael Bothe heads the certification decision board for Active Medical Devices and is also a lead auditor. He is also involved in standardization at the German Institute for Standardization (DIN) and the German Commission for Electrotechnical, Electronic & Information Technologies (DKE) and coordinates continuing education activities for customers. His interests include integrated audits as well as process optimization of conformity assessment procedures.

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