IN VITRO DIAGNOSTIC MEDICAL DEVICE REGULATION
Medical devices have a vital role in providing better diagnosis, prevention, Screening, monitoring, and treatment of various diseases. The COVID -19 pandemic challenge has shown the necessity to have accurate diagnostics and a stringent framework for the in vitro medical devices (IVDs). IVDs are biological tests that can detect disease, condition and infections. In vitro means glass that means the tests are usually conducted in glass test tubes. The examples of IVDs include Pregnancy test device, Glucometer kits to monitor blood sugar, HIV test kit, COVID 19, and many more.
In Europe, the in vitro diagnostic medical devices (IVDs) have been regulated by EU Directive (98/79/EC) since 1993. Currently, EU has progressive roll out new 体外诊断医疗器械调节 (IVD Regulation). It entered into force in May 2017 and became applicable on 26 May 2022. The new regulation is known as欧洲体外诊断医疗器械调节 (EU IVDR) which has replaced older IVDD.
欧洲体外诊断医疗器械调节 （欧盟IVDR）：概述
The EU lawmakers did not change any requirements of the In vitro Diagnostic Regulation (IVDR) but only changed the transitional provisions to allow the Regulation’s gradual application.EU updated the rules with a purpose to improve the safety of IVDs. The duration of transition periods depends on the type of device. For example, the transition period for higher risk devices that is class D such as HIV or Hepatitis and few Class C devices such as influenza is until May 2025 and 2026, while lower risk devices belonging to Class A and B have transition periods till May 2027.
IVD监管应该从2022年5月26日起生效，但通知机构的大流行情况和短缺，无法让医疗设备制造商及时进行符合性评估程序。The notified body will play an important role for the conformity assessment for the safety and performance requirements for some medical devices such as pregnancy, SARS -CoV -2, HIV test.For the new devices which do not have a notified body certificate or a declaration of conformity under the current Directive 98/79/EC, the IVD Regulation will be applied from 26 May 2022.
Read More –IVDR技术文件
IVDRS下诊断装置的分类。
According to IVD Regulation (EU) 2017/746, medical devices are classified as classes A, B, C and D, based on the intended purpose of the devices and risks associated.
Class A:(个体风险低）它包括一般实验室使用产品，附件缓冲解决方案，洗涤解决方案和一般文化媒体等。
Class B：适用于个人的风险，它包括用于自检的设备，例如妊娠试验或胆固醇自检。
Class C:Moderate for public health and high risk for individuals It includes devices intended to be used for blood grouping, cancer markers , genetic testing etc
Class D：高公共健康风险它包括用于检测血液中可传递代理人的存在或暴露的装置的装置
Read More –IVDR分类 - CE标记188bet金搏宝滚球
DIFFERENCE BETWEEN IVDD AND IVDR
The IVDR has replaced current Directive 98/79/EC which ensures a high level of protection of public health and smooth functioning.It has increased the involvement of independent conformity assessment bodies i.e., notified bodies, where a very small number of high-risk devices are subjected to notified bodies.It has improved transparency by providing comprehensive EU database on medical devices (EUDAMED)
IVDR的质量管理系统要求
Quality Management System is one of the most significant requirements according to the new IVDR. The manufacturers shall continuously create and maintain informative QMS for their products.The Article 10 (8) states that an adequate process should be implemented so that the production meets the IVDR conformity. A manufacturer’s QMS should include the parameters as follow:
- 设计变更
- Process verification/validation
- 生产过程控制
- 法规遵守
- 风险管理
- Performance evaluation
- 上市后监测
IVDR强调文件，实施和维护质量系统。
Read More –
- Roles and responsibilities: QMS and the IVDR
- GSPR Requirements for EU MDR & IVDR
- 欧洲Authorized Representative FAQs
- 欧盟医疗器械调节
结论
体外诊断医疗器械监管（欧盟）2017/746（IVDR）已经为体外诊断医疗器械奠定了新的监管框架。 The examples include HIV tests, pregnancy tests or SARS-CoV-2 tests. There is an increase in the involvement of independent notified bodies. 制造商将不得不适应其设备的质量管理系统，以便在过渡期之前提前申请通知的身体。
On an average 80% of in vitro diagnostic medical devices will be under the control of notified bodies. According to new IVD regulation in-house devices are exempted from the IVD Regulation.新规则设定了对体外设备和规则的理由的要求，以确保它们是安全和有效的。 The additional transitional periods granted would help to and are necessary to avoid interruption in the supply of in vitro diagnostic medical devices.