GSPR Requirements for EU MDR & IVDR

 

GSPR Requirements for EU MDR and IVDR the EU Parliament published on 05 May 2017 sets forth new and important requirements for medical device and in vitro diagnostic manufacturers that distribute products in the EU. New General Safety And Performance Requirements for EU MDR & IVDR is for ensuring that devices placed on the EU market are fit for the new technological challenges. In this respect, the new texts lay down certain new General Safety And Performance Requirements for EU MDR & IVDR for all medical devices that incorporate electronic programmable systems and software that are medical devices in themselves. 

GSPR Requirements for EU MDR and IVDR

The medical sector plays a crucial role not only to the health of European Union (EU) citizens but to the European economy as well. The medical devices market in the EU contributes to one-third of the global market, at around €110 billion.Due to the COVID-19 pandemic and increased demand for medical devices, the European Parliament agreed to the EU Commission’s proposal to postpone the application of the MDR by one year. It is essential that the majority of medical producers around the world are compliant with the EU MDR/IVDR. Hundreds of thousands of products will need to be re-certified in order to continue being sold in the European market. 

Main Requirements of GSPR

The requirements of GSPR is covered in Annex I of MDR with 3 chapters.

Chapter 1 – General requirements

Chapter II – Requirements regarding design and manufacture

Chapter III – Requirements regarding the information supplied with the device

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