§ 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

Recognized medical laboratories