Medical Device Safety
We ensure more safety – Ordinance on the Construction, Operation and Application of Medical Devices (Medical Devices Operator Ordinance — 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 the Commissioner for Medical Device Safety.
Tasks
The Commissioner for Medical Device Safety serves as the central point in the health facility and performs the following tasks for the operator:
- acting as the contact person for authorities, manufacturers, and distributors regarding reports of medical device risks and the implementation of necessary corrective measures
- coordinating the health facility’s internal processes to fulfil the reporting and cooperation obligations of users and operators, and
- coordinating the implementation of corrective actions and recalls by the person responsible under § 5 of the Medical Devices Act within healthcare institutions
Source: § 6 paras. 1 and 2 MPBetrV in the version of 01.01.2017.
Do you have any questions?
Our Commissioner for Medical Device Safety can be reached at the following e‑mail address.
Contact: medizinprodukte@neue-augen.de