Biocompatibility and Medical Device Regulation

11B2089

Bachelor

German

5.0

only summer term

1 semester

The biocompatibility or tissue compatibility of medical products is the most important criterion for the approval of industrially manufactured materials for use in the human body. The Medical Device Regulation (MDR) and other regulations describe the necessary requirements for the categorization, approval and use of dental materials. In this module, students are made aware of the relevance of the topic and practise dealing with current standards/regulations.

1. biocompatibility

1.1 General definitions and terms

1.2 Local and systemic toxicity and effect potentials, sensitization, allergic reactions, 

1.3 Interaction between alloplastic materials and living cells/tissues

1.4 Physico-chemical parameters for the description of biocompatible materials

1.5 Medical approval procedures for clinical use: cell and molecular biological in vitro, animal and clinical testing of medical devices, testing for genotoxicity, cytotoxicity, reproductive toxicity and carcinogenicity

2. medical device regulations

2.1 Interpretation of national and international regulations on medical devices and biomaterials

2.2 Approval procedures for medical devices

2.3 Interaction of the regulations with quality management 

2.4 Case studies and exercises in the group on selected examples

The total workload for the module is 150 hours (see also "ECTS credit points and grading").

• Project Report, written

Project report, written: approx. 20 pages,
accompanying explanation: approx. 20 minutes

Knowledge of anatomy and the fundamentals of materials science is required; knowledge of dental treatment concepts and conventional dental technology is advantageous.

Students will be able to present regulations on medical devices and biocompatibility tests. They can classify the risks of materials for medical devices.

Students will be able to define and discuss the necessary biocompatibility tests.

Students can assess the risks of materials for medical devices.

Students can evaluate changing regulations.

Students can present the results of their work orally and in writing in a clearly structured form.

Students can explain decision-making situations and the associated issues in interdisciplinary contexts in a critically reflective manner.

• Wehmöller, Michael

• Wehmöller, Michael