Module 19 2021

02/06/2021

IVD Risk Management

• Risk Management is important in IVDD • Risk Management is essential in IVDR

‘Manufacturers shall establish, implement, document and maintain a risk management system’ – IVDR Art. 10, Annex I part 3

2017/746/EU

Reference to ‘risk’ ....

IVDD 98/79/EC

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Take home messages

 Well defined systematic process to determine product safety and effectiveness

 Embedded throughout QMS/ ISO 13485 / MDSAP  Critical for ongoing compliance to the IVD Regulation  Appropriate to product type and risk  Requires collective collaboration of expertise  Can be a very useful tool

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