10-Step Guide to IVDR Preparation

From May 26, 2022, in vitro diagnostics devices will need to meet the requirements of the IVDR (In Vitro Diagnostics Regulation 2017/746). Its objective is to validate the safety and efficacy of in vitro diagnostics more thoroughly and proactively.

The main changes are:

• Product scope expansion
• Device reclassification
• More rigorous clinical evidence
• More stringent documentation
• Identification of a person responsible for regulatory compliance (PCCR)
• Greater scrutiny by Notified Bodies
• Increased PMS requirements

Download your free copy of the infographic and discover 10 specific steps to help you prepare for the IVDR.

We hope you enjoy the IVDR infographic and that it provides you with some useful insights. If you have any questions, please do not hesitate to contact us: hello@climedo.de

About Climedo Health

Climedo Health's mission is to bring the best treatment to every patient by empowering healthcare professionals with intelligent software solutions. Together with Europe’s leading hospitals, we have developed a cloud-based platform for cutting-edge clinical validation and post-market surveillance of medical devices and pharmaceutical products.

By digitally connecting all stakeholders (Medical Device manufacturers, Pharma companies, CROs, hospitals and patients), Climedo allows for increased performance, better cost-efficiencies - and ultimately - accelerated medical innovation. Learn more: www.climedo.de