Name:	Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH at the university Ulm (responsible in the sense of TMG)
Address:	Lise-Meitner-Str. 8/2 D-89081 Ulm
Contact:	tel.: +49 (0) 731 / 50 990-0 fax: +49(0) 731 / 50 990-22 e-Mail: diabetes@ifdt-ulm.de
HR Ulm	HRB 1800
Tax number:	DE 210 64 98 66
Authorized representative:	Director: Dr. med. Guido Freckmann

The current regulation on the establishment, operation and application of medical devices (Medical Devices Operator Ordinance – MPBetreibV) requires in § 6, section 1, that healthcare facilities with more than 20 employees have to designate a representative for medical device safety. This person has to be competent and reliable and must have a medical, scientific, nursing, pharmaceutical or technical education. 

The representative for medical device safety takes on the following tasks for the operator as a central element: 

 

1. To be a contact person for authorities, manufactures and distributors in the context of notifications about risks associated with medical devices and in the implementation of safety and additional necessary correction measures in the field.  

 

2. To coordinate internal processes of the healthcare facility for compliance with reporting and cooperation obligations by users and operators.

 

3. To coordinate the implementation of correction measures and safety correction measures in the field in healthcare facilities.

 

The following functional email address is for the representative for medical device safety at our institute:  Medizinproduktesicherheit@ifdt-ulm.de

 

 

 

 

 

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