The Medical Devices Introductory Course 2020

INNOVATIVE DEVICE

• Confirm your innovative MEDICAL DEVICE or IN-VITRO DIAGNSOTIC DEVICE • Be creative! Poetic licence and fertile imagination is allowed and is encouraged! Do not be restrained by current technological constraints. Technological feasibility is not a required element of this case study. • Think about the product concept, intended use and claims. • Create a brand name and basic label copy • Confirm: Classification, Conformity Assessment route(s) and key GSPRs

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Case Study Resources

Resources at your disposal:

 Your Team! Work as a team! (Please ensure everyone participates)

 Module Advisor / Presenter(s) – 1 Team Only (Sorry!) - non-specific assistance and general advice only

 Search for internet resources for each device  Product materials – if supplied

 Course materials [remember key references from presentation(s), for example...]: ● MDR 2017/745 – Article 52 for Conformity Assessment Procedures and Annex I for GSPRs ● MDD 93/42/EEC – Article 11 and Annex I for ERs

The Organisation for Professionals in Regulatory Affairs