2017年5月5日发布的欧盟MDR和IVDR的GSPR要求欧盟议会发布的医疗设备和在欧盟分配产品的体外诊断制造商的新的和重要要求。NewGeneral Safety And Performance Requirements for EU MDR & IVDRis 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 newGeneral Safety And Performance Requirements for EU MDR & IVDRfor all medical devices that incorporate electronic programmable systems and software that are medical devices in themselves.
- AsCE mark consultantsfor medical devices we’ll help you for the process of making a defined technical file with all the product details.
- We will help you in meeting European submission standards that state the product offered is in compliance with the exact requirements of European safety.
The MDCG guidance provides a listing of all GSPR Requirements for EU MDR and IVDR在MDR附件I＆IVDR附件我与网络安全有关。MDR和IVDR要求医疗器械制造商，以考虑在设计，开发和升级跨生命周期的医疗设备时考虑最新技术。
基本rers should demonstrate state-of-the-art within their decisions (based on applicable standards, guidance, their own proprietary knowledge and publicly available scientific / technical information) while demonstrating appropriateness to proportionally address security risk.
GSPR Requirements for EU MDR and IVDR
医疗部门不仅对欧洲联盟（欧盟）公民的健康以及欧洲经济也起到了至关重要的作用。欧盟的医疗器械市场有助于全球市场的三分之一，达到1100亿欧元。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.
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General Safety and Performance Requirements for EU MDR & IVDR适用于所有医疗器械类，以及制造过程中的设计阶段。Additional steps include the development of quality and risk management systems, as well as conducting a benefit-risk analysis and clinical evaluations.基本rers are also required to supply label information, including instructions of use.The MDR/IVDR obligates the manufacturer or authorized representative in the EU to generate the technical documentation and sign the declaration of conformity.
All technical documentation must be kept for 10 to 15 years depending on the device type.基本rers must draw a post-market surveillance technical file to show how the performance data about their device is collected.Indeed, the new regulations offer better coordination mechanisms and post-market surveillance.The essential requirements (ER) are the key elements to compliance with MDD and AIMDD. The new regulation EU MDR replaces the essential requirements (ER) byGeneral Safety And Performance Requirements for EU MDR & IVDR(GSPR).
General Safety And Performance Requirements for EU MDR & IVDR（欧盟MDR）几乎类似于基本要求（MDD），还有一些额外的要求和一些扩展的要求，并在GSPR中引入了一些新主题。
Main Requirements of GSPR
GSPR的要求被3章的MDR附件一所涵盖。
Chapter 1 – General requirements
Chapter II – Requirements regarding design and manufacture
Chapter III – Requirements regarding the information supplied with the device
Fulfilling the general safety and performance requirements listed in Annex I is one of the most fundamental preconditions to placing any medical device on the European mark. “Placing on the market and putting into service”. The “requirements” are a set of product characteristics, which are considered by the European authorities as being essential to ensuring that any new device will be safe and perform as intended throughout its life.