Module 15 2022

19/05/2022

Implantable and class III devices Devices approved and on the market under MDD/AIMD: Article 61.6a ● which have been lawfully placed on the market or put into service in accordance with Directive 90/385/EEC or Directive 93/42/EEC ● Where the clinical evaluation: – is based on sufficient clinical data – is in compliance with the relevant product-specific CS for the clinical evaluation of that kind of device, where such a CS is available ● Justification for not conducting a clinical investigation is required in the CER and the Clinical Evaluation Assessment Report (CEAR)

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

45

Implantable and class III devices

Certain Listed Devices : Article 61.6b

● sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors ● the clinical evaluation is based on sufficient clinical data ● in compliance with the relevant product-specific Common Specification (CS), where such a CS is available. ● Justification for not conducting a clinical investigation is required in the CER and the Clinical Evaluation Assessment Report (CEAR)

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

46

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