Module 14 2022

22/03/2022

Content of the STED

Is it a single device, or composed of several components? e.g. A wound drainage device may have 3 components that must be taken into consideration: • the cannula, • the tubing • the collector unit. If sold as a single item, then the highest class would apply – in this example Class IIa for the cannula (as it is surgically invasive) – the tubing and collector would be Class I

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

11

Content of the STED

MDR Annex II and III Detailed Structure of STED described in IMDRF 2019 Guidance • Device Description (including development history) • Indications for use • Non-clinical Evidence • Risk Management • Essential Principles Checklist • Non-clinical studies • Clinical Evidence • Labelling and Promotional Material • Quality Management System

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

12

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