Zentralstelle der Länder für Gesundheitsschutz
bei Arzneimitteln und Medizinprodukten



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 17025internal Link

Recognized medical laboratories

Directives 90/385/EEC, 93/42/EEC and EN ISO 15189internal Link

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