Essentials of European Medical Device Regulatory Affairs - October 2019

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)

http://ec.europa.eu/growth/sectors/medical‐devices/guidance_en

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Guidelines MDR-MDCG Documents UDI

Issuing entities, application (9)

EUDAMED

Timelines, legacy devices (2)

Notified Bodies Designation, certificates (2 + 10 NBOG) Clinical Investigation SSCP: Summary of safety and Clinical and Evaluation Performance (1) Other Topics: - Responsible Person - Implant Cards - Article 54(b) expert panel exemptions

https://ec.europa.eu/growth/sectors/medical‐devices/new‐regulations/guidance_en

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