RECOGNIZED LABORATORIES according to § 15 (5) Medical Devices Act
§ 15 (5) of the Medical Devices Act which was amended in 2009 has become effective on 21 March 2010. According to this, the competent authority, here ZLG, has to determine in a recognition procedure that certain laboratories fulfil the minimal criteria set out in Annex 8 of Directive 90/385/EEC, Annex XI of Directive 93/42/EEC and Annex IX of Directive 98/79/EC.
Recognized testing laboratories for medical devices
Directives 90/385/EEC, 93/42/EEC, 98/79/EC and EN ISO/IEC 17025
Recognized medical laboratories
Directives 90/385/EEC, 93/42/EEC and EN ISO 15189
NOTIFIED BODIES/CERTIFICATION BODIES
Notified Bodies according to § 15 Medical Devices Act
In accordance with § 15 (4) of the German Medical Devices Act current information on the scope of designations as well as the identification numbers of German Notified Bodies in the area of medical devices are published on the website of ZLG as the German Designating Authority in that area. These information as issued by ZLG are authoritative and reflect the current status of designations. Information on the status and scope of designations on the website of the European Commission´s Nando (New Approach Notified and Designated Organisations) Information System may deviate. As indicated also on the website of the Nando Information System the data given there are for information only since designation and notification of Notified Bodies are within the responsibility of the Member States. Please do not hesitate to contact ZLG in case of questions.
List of identification numbers of Notified Bodies according to § 15 Medical Devices Act
List of all European Notified Bodies by identification number
CONFORMITY ASSESSMENT BODIES FOR THIRD COUNTRIES ACCORDING TO § 15a MEDICAL DEVICES ACT
Confirmity assessment bodies for third countries - Australia
Confirmity assessment bodies for third countries – New Zealand
Confirmity assessment bodies for third countries – United States of America