Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

2006/42/EC Machinery Directive

 Directive – Published 17 May 2006

• IVDR Article 1.6 requires devices which are also machinery e.g. large lab analysers to meet requirements of Annex I of 2006/42/EC where those requirements are more specific than GSPR • Directive speaks to design of machine feature to ensure safe operation • Annex 1 lists all hazard considerations mechanical e.g. moving parts

and others e.g. laser operation, electrocution etc. • Should form part of risk management FMEAs

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GDPR – 2016/679 General Data Protection Regulation

 Regulation – Published 27 April 2016 • Came into full force 25 May 2018 • No existing consents or systems could be grandfathered • Principle is Data protection/ownership of personal data is a fundamental human right

The Organisation for Professionals in Regulatory Affairs

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