The Agreement on the Central Authority of the Laender for Health Protection Regarding Medicinal Products and Medical Devices (ZLG) (text of agreement) states the maintenance and improvement of the level of quality and safety of medical devices as an objective of the ZLG's work based on
- directive 90/385/EEC
of the Council dated 20 June 1990 regarding active implantable medical devices,
- directive 93/42/EEC
of the Council dated 14 June 1993 regarding medical devices, and
- directive 98/79/EC
of the European Parliament and the Council dated 27 October 1998 regarding in vitro diagnostic medical devices.
These European directives were transformed into national German legislation by the Medical Devices Law (MPG) and its enacted ordinances.
The implementation of the MPG is within the responsibility of the Laender. In the area of medical devices, the ZLG performs the tasks of the 16 Laender with regard to recognition and designation. This includes particularly the recognition and monitoring of testing laboratories and certification bodies in the area of medical devices and in vitro diagnostic medical devices.
Until end of 2009 ZLG was also responsible for the accreditation in the fields described above. Due to Regulation (EC) No. 765/2008, in 2010 a central national accreditation body – Deutsche Akkreditierungsstelle GmbH (DAkkS) – (DAkkS) was established. In accordance with the Federal Act on the Accreditation Body, ZLG is now performing assessments of conformity assessments bodies for accreditation purposes in the medical devices area on behalf of DAkkS.
Expert committees (sectoral committees and horizontal working committees) formed by ZLG help in drawing up regulations regarding the requirements to be applied during testing and certification.
Furthermore, the ZLG is responsible for the recognition, designation and supervision of conformity assessment bodies in the framework of mutual recognition agreements of the EC with third countries.
The ZLG is the office for the information exchange of notified bodies.
The ZLG participates in information exchange at EU level, as well as in consultations within the framework of EC agreements with third countries (texts of agreements) and works together in confidence-building programmes as well as in Joint Committee working groups.