The key differences between MDR and IVDR in the EU
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Comparison OF The Key Differences Between The MDR And IVDR In The EU
In the fast-paced world of medical devices, staying updated on regulatory changes is crucial for manufacturers, healthcare professionals, and patients alike. In the European Union (EU), two significant regulations have been introduced to enhance the safety and effectiveness of medical devices – the In Vitro Diagnostic Regulation (IVDR) and the Medical Device Regulation (MDR).
The need for new regulations for medical devices and in vitro medical devices (IVD) arises from the dynamic nature of the healthcare industry and advancements in technology. The regulatory landscape for these devices was recognized as outdated and insufficient to address the evolving challenges and risks associated with their use. The European Union responded to these concerns by introducing the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR).
The key objectives of the new regulations, Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), are to enhance the identification of medical devices, standardize data across the industry, and incorporate technological advancements. These regulations strive to establish a robust framework that guarantees the safety, effectiveness, and quality of medical devices.
This blog aims to provide a comprehensive overview of both regulations, highlighting their key points and key differences.
EUROPEAN-COMMISSION
I. IN VITRO DIAGNOSTIC REGULATION (IVDR):
The In Vitro Diagnostic Regulation (IVDR), Regulation (EU) 2017/746, was adopted by the European Parliament and the Council in 2017 and came into effect on 25 May 2017. It replaced the previous In Vitro Diagnostic Directive (IVDD) 98/79/EC and introduced a more stringent framework for the approval and marketing of in vitro diagnostic medical devices (IVDs). This regulation specifically pertains to in vitro diagnostic medical devices distributed within the European Union.
The implementation of In Vitro Diagnostic Regulation (IVDR) introduces a more stringent regulatory framework compared to its predecessor, the IVDD. Companies engaged in the manufacturing of in vitro diagnostic medical devices are subject to the In Vitro Diagnostic Regulation (IVDR), with the deadline for compliance set at May 2022. Compliance involves the submission of comprehensive technical documentation, which is a prerequisite for authorization and market entry.
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