Medical device safety officer under the MPBetreibV
Healthcare facilities that regularly have more than 20 employees must appoint a medical device safety officer (Beauftragter für Medizinproduktesicherheit). This person is the central point of contact for the tasks under § 6 of the German Medical Devices Operator Ordinance (MPBetreibV). In this guide, “operator” means the person or organisation legally responsible under the MPBetreibV, not the individual user of the device.
Who must appoint an officer?
Healthcare facilities that regularly have more than 20 employees must ensure that a medical device safety officer is appointed. If an operator runs several healthcare facilities, an officer must be appointed for each facility with more than 20 employees.
Which qualifications are required?
The officer must be competent and reliable and have a medical, scientific, nursing, pharmaceutical or technical education.
What are the officer's tasks?
Under § 6 MPBetreibV, the tasks include in particular:
- acting as the contact person for authorities, manufacturers and distributors in connection with reports on risks posed by devices, and for field safety corrective actions and other necessary corrective measures,
- coordinating internal processes for meeting the reporting and cooperation duties of users and operators,
- coordinating the implementation of corrective measures and field safety corrective actions.
The officer must not be obstructed in carrying out these tasks and must not be put at a disadvantage for doing so.
Functional email address
The operator must ensure that a functional email address of the officer is published on the healthcare facility's website or made known in another suitable way.
What matters in practice
The appointment is quickly done. After that it comes down to organisation. In our experience, these points most often lead to gaps:
- The functional address exists but is not read or cannot be found publicly.
- After a staff change, there is no new appointment or arranged cover.
- When questions about a device arise, inventory, measures and records are not available in one place.
- Where an operator runs several healthcare facilities, it is overlooked that an officer must be appointed for each facility with more than 20 employees.
How Aurel helps
Aurel assigns deadlines, completed measures and related evidence to the respective device. This keeps the inventory and the history of measures available in one structured place when questions about a device arise, without maintaining parallel spreadsheets.
Book a call