Publisher : EUROPEAN UNION-COMMISSION LEGISLATIVE DOCUMENTS

EU/EC MEDDEV 2.4/1 PDF

GUIDELINES RELATING TO THE APPLICATION OF THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES

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EU/EC MEDDEV 2.5/10 PDF

GUIDELINE FOR AUTHORISED REPRESENTATIVES

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EU/EC MEDDEV 2.5/2 PART 1 PDF

GUIDELINES FOR REGULATORY AUDITING OF QUALITY SYSTEMS OF MEDICAL MANUFACTURERS PART 1: GENERAL REQUIREMENTS: 1998

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EU/EC MEDDEV 2.5/3 PDF

SUBCONTRACTING – QUALITY SYSTEMS RELATED

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EU/EC MEDDEV 2.5/5 PDF

TRANSLATION PROCEDURE

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EU/EC MEDDEV 2.5-7 PDF

GUIDELINES FOR CONFORMITY ASSESSMENT OF BREAST IMPLANTS ACCORDING TO DIRECTIVE 93/42/EEC RELATING TO MEDICAL DEVICES

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EU/EC MEDDEV 2.5-8 PDF

Guidelines on assessment of medical devices incorporating materials of animal origin with respect to viruses and transmissible agents

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EU/EC MEDDEV 2.5/9 PDF

IMPLICATIONS OF THE MEDICAL DEVICES DIRECTIVES (93/42/EEC) IN RELATION TO MEDICAL DEVICES CONTAINING NATURAL RUBBER LATEX: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES

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EU/EC MEDDEV 2.7/1 PDF

GUIDELINES ON MEDICAL DEVICES CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC

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EU/EC MEDDEV 2.7.1 PDF

GUIDELINES ON MEDICAL DEVICES CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES

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