Module 14 2022

22/03/2022

Effect of MDR

• Broader scope • Some products will be reclassified • Fewer products will fall into Class I, self certified, and those upclassified devices will need NB assessment • Greater expectations for supporting performance/effectiveness • Importance of well written clinical evaluation report and design history • All products have to be reassessed for conformance with MDR requirements (no grandfathering)

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

5

Documentation

What do we need? • STED (Summary Technical Documentation) file

STED is the basis on which the Declaration of Conformity, and hence compliance with the Essential Principles, is DEMONSTRATED Where do we get the information from to complete the STED? • Manufacturer’s Technical Documentation • Documents generated under the manufacturer’s Quality Management System • IMDRF gives a nice overview of how documents in the Manufacturer’s Technical Documentation translate into a STED file

Masterclass Lecture 8

The Organisation for Professionals in Regulatory Affairs

6

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