MEDDEV

 MEDDEV 2.5/10
⇨ GUIDELINE FOR AUTHORISED REPRESENTATIVES

MEDDEV 2.7/1 Rev.4
⇨ CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC

MEDDEV 2.1/1
⇨ DEFINES MEDICAL DEVICES, ACCESSORIES AND MANUFACTURER

MEDDEV 2.12/2 Rev.2
⇨ POST MARKET CLINICAL FOLLOW UP FOR MEDICAL DEVICES

MEDDEV 2.12/1 Rev. 1
⇨ EMC REQUIREMENTS

MEDDEV 2.2/3 Rev. 3
⇨ USE-BY DATE

MEDDEV 2.2/4
⇨ CONFORMITY ASSESSMENT OF IVF AND ART PRODUCTS

MEDDEV 2.4/1 Rev. 9
⇨ CLASSIFICATION OF MEDICAL DEVICES

MEDDEV 2.5/6 Rev. 1
⇨ HOMOGENEITY OF PRODUCTION BATCHES

MEDDEV 2.5/9 Rev. 1
⇨ MEDICAL DEVICES CONTAINING NATURAL RUBBER LATEX

MEDDEV 2.7/2
⇨ VALIDATION/ASSESSMENT OF A CLINICAL INVESTIGATION APPLICATION UNDER DIRECTIVES 93/42/EEC & 90/385/EEC

MEDDEV 2.7/4
⇨ CLINICAL INVESTIGATION

MEDDEV 2.5/7 Rev. 1
⇨ CONFORMITY ASSESSMENT FOR BREAST IMPLANTS

MEDDEV 2.1/2.1
⇨ TREATMENT OF COMPUTERS USED TO PROGRAM IMPLANTABLE PULSE GENERATORS

MEDDEV 2.1/6
⇨ QUALIFICATION AND CLASSIFICATION OF STAND ALONE SOFTWARE

MEDDEV 2.11/1 Rev. 2
⇨ RISK MANAGEMENT IN ANIMAL TISSUE PRODUCTS – TSE

MEDDEV 2.14/4
⇨ CE MARKING OF BLOOD BASED IVD MEDICAL DEVICES FOR VCJD

MEDDEV 2.7/3
⇨ CLINICAL INVESTIGATIONS: SERIOUS ADVERSE EVENT REPORTING

MEDDEV 2.14/1 Rev. 2
⇨ IVD BORDERLINE AND CLASSIFICATION ISSUES

MEDDEV 2.1/3 Rev. 3
⇨ BORDERLINE PRODUCTS: DRUG DELIVERY PRODUCTS AND MEDICAL DEVICES

MEDDEV 2.12/1 Rev. 8
⇨ MEDICAL DEVICES VIGILANCE SYSTEM

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