Medical device safety

In compliance with applicable provisions of law, the Municipal Hospital of Pirmasens has appointed a Medical Devices Safety Officer.

This is mandated by amendments to German legislation pertaining to medical devices. These amendments went into effect on 1 January 2017 together with the Second Ordinance to Amend Regulations Concerning Medical Devices.

The tasks of the Medical Device Safety Officer are described in Section 6 of the Medical Devices Operator Ordinance [MPBetreibV – Medizinprodukte-Betreiberverordnung].


The tasks include:

  • Serving as a contact person for authorities, manufacturers and distributors in connection with reports on the risks of medical devices, as well as in the implementation of necessary corrective measures
  • Coordination of internal processes of the health institution to comply with the notification and cooperation obligations of users and operators
  • Coordination of implementation of corrective and recall measures in healthcare institutions on the part of those responsible, pursuant to Section 5 of the German Medical Devices Act [Medizinproduktegesetz]


In case of need, authorities, manufacturers and distributors of medical devices are free to contact the Medical Device Safety Officer of the Municipal Hospital of Pirmasens at any time.

Contact the Medical Device Safety Officer

Heidi Helfrich Heidi Helfrich

Telephone:
06331/714-3231
Fax:
06331/714-2471
beauftragterfuermedizinprodukte-
sicherheit@kh-pirmasens.de