Medical Device Safety Officer
Central contact for medical-device incidents and field safety corrective actions. Coordination with authorities and manufacturers, dissemination of safety notices, vigilance reporting documented.
MPDG § 15 · MPBetreibV · MDR (EU) 2017/745
Talk to us about Medical Device Safety Officer
Three lines and you are in our inbox. We reply within one business day.
What does a Medical Device Safety Officer do?
A Medical Device Safety Officer (Beauftragte für Medizinproduktesicherheit) is the central contact within a health institution for everything to do with the safety of medical devices. The role is established by Sec. 15 of the Medical Devices Implementation Act (Medizinprodukterecht-Durchführungsgesetz, MPDG), which requires institutions that regularly use medical devices to designate such an officer. The officer is the named interface between the institution, the competent authorities, manufacturers and distributors for risk reports and safety-related information.
In day-to-day work the officer receives, assesses and forwards reports of incidents (Vorkommnisse) involving medical devices, coordinates field safety corrective actions (FSCA) and disseminates field safety notices internally so that affected devices are removed, corrected or used under amended instructions. They ensure that the institution meets its reporting obligations within the vigilance system of the MDR, Regulation (EU) 2017/745, and the MPDG, and that each report and corrective action is documented. They also support operator duties under the Medical Devices Operator Ordinance (Medizinprodukte-Betreiberverordnung, MPBetreibV), such as inspections, maintenance and the device register.
The officer cooperates with the authorities, in Germany the federal institute responsible for medical-device vigilance, and with the manufacturers whose corrective actions must be implemented. They keep records of incidents, FSCA, safety notices and the resulting internal measures so the institution can demonstrate at any time that it identified, reported and acted on device risks. The aim is a documented vigilance and safety process that protects patients and staff and satisfies the MPDG, MPBetreibV and MDR.
Core duties of the Medical Device Safety Officer
- Act as the central contact for medical-device safety under Sec. 15 MPDG for authorities, manufacturers and distributors.
- Receive, assess and forward reports of incidents (Vorkommnisse) within the vigilance system of MDR (EU) 2017/745 and the MPDG.
- Coordinate field safety corrective actions (FSCA) and ensure affected devices are corrected, withdrawn or restricted.
- Disseminate field safety notices (FSN) internally and confirm the required actions are carried out.
- Ensure reporting obligations and deadlines under the MDR vigilance regime and MPDG are met and documented.
- Support operator duties under the MPBetreibV, including inspections, maintenance and the medical device register.
- Maintain records of incidents, corrective actions and safety notices as evidence of vigilance.
- Cooperate with the competent authority and manufacturers on risk assessment and corrective measures.
- Brief clinical and technical staff on how to recognise and report device incidents.
- Review whether internal measures resolved the risk and feed lessons back into operator processes.
When is a Medical Device Safety Officer required?
Under Sec. 15 MPDG, health institutions that regularly use medical devices, such as hospitals and larger care or treatment facilities, must designate a Medical Device Safety Officer and publish a way to contact them, typically on the institution's website. The officer must have the technical expertise needed to assess device-safety information and must be independent enough in the function to carry out the reporting and coordination duties without conflict.
The role exists because the vigilance system of the MDR, Regulation (EU) 2017/745, and the MPDG depends on a reliable point of contact inside each institution to capture incidents, channel them to the authority and implement manufacturers' corrective actions. Smaller users who do not meet the institutional threshold still have to report serious incidents, but the named officer becomes mandatory once the institution falls within Sec. 15 MPDG. The designation should be documented, the officer given the resources and access to do the job, and the contact details kept current. Operator duties under the MPBetreibV apply in parallel and are often supported by the same officer or a closely linked device-management function.
- Health institution regularly using medical devices under Sec. 15 MPDG
- Obligation to publish the officer's contact details
- Vigilance reporting duty under MDR (EU) 2017/745
- Incident and FSCA handling under the MPDG
- Operator duties under the MPBetreibV
- Authority request relating to device safety
Sectors that appoint a Medical Device Safety Officer
- Hospitals and clinics
- Rehabilitation facilities
- Dialysis and outpatient surgery centres
- Care homes using medical devices
- Medical care centres (MVZ)
- Dental and specialist practices at scale
- University medical centres
- Blood and transfusion services
- Diagnostic and laboratory facilities
How CIVAC supports the Medical Device Safety Officer role
CIVAC gives the Medical Device Safety Officer one workspace to run vigilance reliably. Task templates cover recurring duties such as device inspections and maintenance under the MPBetreibV, FSCA follow-up, safety-notice distribution and reporting-deadline checks, each with a reminder so nothing slips. The documentation area stores incident reports, field safety notices, corrective-action records and the device register, mapped to Sec. 15 MPDG and MDR (EU) 2017/745. The audit trail captures who reported what, when it was forwarded and which internal measures followed, which evidences the institution's vigilance during an authority review. The training library keeps clinical and technical staff able to recognise and report incidents. EU data residency keeps patient-safety records inside the EU.
Frequently asked questions
Need this officer role for your organisation?
Appoint our experts as your external officer or license CIVAC for your in-house team. Get in touch and we walk you through the right setup.