Essentials of European Medical Device Regulatory Affairs

Guidelines MDD-MEDDEVs 2.1 Scope, field of application, definition (7) 2.2 Essential requirements (3) 2.4 Classification of Medical devices (1) 2.5 Conformity assessment procedures: - General rules (4) - 2.7 Clinical investigation, clinical evaluation (4) 2.10 Notified bodies (1 + 4 annexes) 2.11 Products using materials of biological origin 2.12 Post Market surveillance (2 + forms) 2.13 Transitional period (implementation of MDD) (2) 2.14 IVD (4) 2.15 Other guidance (1 on working groups)

Conformity assessment for particular groups of products (3)

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Guidance Documents

http://ec.europa.eu/growth/sectors/medical-devices/guidance_en MEDDEVS for medical device directive.

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