The recognition according to § 15 (5) of the Medical Devices Act states the compliance with medical device directions and relevant standards, especially EN ISO/IEC 17025. The Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) is the responsible agency for the recognition of laboratories.
If a notified body entrusts a laboratory with testing medical devices, a recognized laboratory has to be commissioned. Thus, test reports issued by recognized laboratories are a sound fundation for a conformity assessment by notified bodies.
The recognition is only valid for medical device related testing services. Analysis of biological indicators, chemical indicators and process challenging devices are not included in the scope of the laboratory recognition, as those products are no medical devices. Testing of those producs is included in the laboratory’s Accreditation.
Tests of medical devices included in the scope of the recognition are also accredited.