Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Major Changes to 2019 revision

 Introduction of new terms benefit, reasonably foreseeable misuse and state of the art  Focus on benefits and risk-benefit from the use of the device  Inclusion of data and system security within the standard  Requirements for overall residual risk evaluation  Disclosure of residual risk  Requirement for a risk management report to be available before commercial release of a product

The Organisation for Professionals in Regulatory Affairs

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Risk Management within the QMS

 Embedded throughout ISO 13485:2016  Manufacturers required to show interconnected approach to risk

4.1 General Requirements

7.1 Planning and Product Realization

7.3 Design and Development

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ISO 13485:2016

7.4 Purchasing

7.5 Production and Service Provision

The Organisation for Professionals in Regulatory Affairs

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