Medical Device Safety

We ensure more safety – Ordinance on the Construction, Operation and Application of Medical Devices (Medizinprodukte-Betreiberverordnung — MPBetreibV) § 6 Commissioner for Medical Device Safety

Healthcare facilities with regularly more than 20 employees must ensure that a competent and reliable person with medical, scientific, nursing, pharmaceutical or technical training is designated as a medical device safety officer.

Tasks

The Medical Device Safety Officer performs the following tasks for the operator as a central point in the health facility:

  1. the tasks of a contact person for authorities, manufacturers and distributors in connection with reports  on risks of medical devices and in the implementation of necessary corrective measures
  2. the coordination of internal processes of the health institution to fulfil the reporting and cooperation obligations of users and operators, and
  3. the coordination of the implementation of corrective measures and the recall measures by the person responsible in accordance with § 5 of the Medical Devices Act in the healthcare institutions

Source: § 6 para. 1 and 2 MPBetrV in the version of 01.01.2017.

Do you have any questions?

Our person responsible for medical device safety can be reached at the following e-mail address.

Contact: medizinprodukte@augenarzt-banyai.de

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