Combination products containing medicinal products or active substances can be covered under both the MDR or Directive 2001/83/EC. We would like to invite you to get an overview on this topic.

For the handling of material medical devices, DQS Medizinprodukte GmbH has prepared an information based on the requirements of the (EU) 2017/745 Medical Devices Regulation (MDR). This information addresses definitions of combination products, classification rules, conformity assessment procedures, quality management system requirements and much more.

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Learn more about material medical devices under MDR

* Recitals
* Definition of Combination Product
* Classification Rules
* Conformity Assessment Procedures
* QMS Requirements
* Responsible Person
* Technical Documentation

Michael Bothe

Michael Bothe is Head of the Notified Body 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.