标准2025新的欧洲医疗器械法规（MDR）和体外诊断医疗器械法规（IVDR）已公布在欧盟官方公告。上述法规将于5月26日正式生效，标志着在欧洲销售医疗器械的制造商过渡期开始。
1、关于医疗器械法规
2017年4月5日欧洲议会和欧盟理事会关于医疗器械的2017/745法规（EU），修订了2001/83 / EC指令，178/2002法规（EC）和1223/2009法规（EC），撤消了理事会指令90/385 / EEC和93/42 / EEC。
MDR替代了医疗器械指令（93/42/EEC）和有源植入式医疗器械指令（90/385/EEC），并有三年过渡期，之后将正式实施，不接受针对该指令的任何新申请。制造商可以利用过渡期更新其技术文件和流程，以满足新的要求。制造商一旦确定了他们的指定机构，就可以针对新法规申请证书了。
这个期待已久的法规提出了更为严格的技术文件要求; 在临床评估和上市后临床随访方面也提出更加严格的要求，并要求供应链上设施有更好的可追溯性，以此解决产品安全性和性能评估方面的潜在风险。
2、关于体外诊断医疗器械法规
2017年4月5日欧盟议会和理事会关于体外诊断医疗器械法规（EU）2017/746法规，废止了98/79 / EC指令和欧盟委员会“2010/227 / EU决定”。
IVDR取代了IVD指令（98/79 / EC），并有五年的过渡期，之后将正式实行，并且不接受任何针对该指令的新申请。制造商可以在过渡期更新其技术文件和流程，以满足更为严格的新要求。制造商一旦确定指定机构后可以针对新法规申请证书。
新的IVD法规标志着IVD监管环境发生了重大转变，在要求方面进行了重大调整，包括新的基于规则的产品分类体系，取代了目前基于列表的方式。这个方法将大大增加需要欧盟公告机构认证其产品的IVD制造商的数量。转向基于规则方法将大大增加要求指定机构认证其产品的IVD制造商的数量，因为分类规则适用于所有的IVE，而不是使用特定产品的排他列表来确定哪些需要指定机构。IVDR向性能评估和临床证据领域引入了新概念。
这些变化的本质体现在制造商过渡期的长短上，同意为制造商提供五年时间的过渡期，对其技术文件和流程进行必要的更改。
BSI全球医疗器械高级副总裁盖里.斯莱克（Gary Slack）表示：“医疗器械的监管格局正在迅速变化，这就带来了医疗器械和IVD监管的转型。我们乐于接受这两部要求更为严格的法规，高要求能促进良好平衡，促使医疗器械制造商进一步优先考虑患者安全，并及时获取创新的医疗器械技术。”
相关组织需要熟悉新的监管要求为自身带来什么变化，评估新要求会为在欧盟销售的整个产品系列产生什么影响。为了协助相关组织，BSI已制定出配套材料，支持这一监管的变革：IVD法规和医疗器械法规。
New Medical Devices Regulation and IVD Regulation text published
The final texts of the new European Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) have been published in the Official Journal of the European Union today. The Regulations will enter into force on May 26th, marking the start of the transition period for manufacturers selling medical devices into Europe.
Read the full EU Commission press release here
Medical Device Regulation
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
The MDR, replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), and has a transition period of three years, after which the Regulation will apply, and no new applications against the Directives will be accepted. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements. Manufacturers can apply for certificates to the new Regulation once their notified body is designated.
This long awaited text brings with it more scrutiny of technical documentation; it addresses concerns over the assessment of product safety and performance by placing stricter requirements on clinical evaluation and post-market clinical follow-up, and requiring better traceability of devices through the supply chain.
In Vitro Diagnostic Regulation
REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.
The IVDR, which replaces IVD Directive (98/79/EC), has a transition period of five years, after which the Regulation will apply, and no new applications against the Directives will be accepted. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new, more stringent requirements. Manufacturers can apply for certificates to the new Regulation once their notified body is designated.
The new IVD Regulation marks a significant shift in the regulatory environment for IVDs. It introduces a number of substantial changes to the requirements, including a new rule-based classification system for products, superseding the current list-based approach. The shift to a rule-based approach will considerably increase the number of IVD manufacturers who require a notified body to certify their products as classification rules are applied to all IVDs, rather than using an exclusive list of specific products to determine which require a notified body. The IVDR also introduces new concepts within the area of performance evaluation and clinical evidence.
The nature of these changes is reflected in the length of the transition period for manufacturers; the five year transition period was agreed to provide time for manufacturers to make the necessary changes to their technical documentation and processes.
Gary Slack, Senior VP, Global Medical Devices at BSI said, “The regulatory landscape for medical devices is a rapidly changing one, and with that comes the transformation of Medical Device and IVD Regulation. We welcome the increased requirements under the two Regulations, facilitating a good balance that allows medical device manufacturers to further prioritize patient safety whilst continuing to provide timely access to innovative medical device technology.”
Organizations need to familiarize themselves with the new regulatory requirements now and evaluate the impact this will have on their entire product range sold in the EU. To assist organizations, BSI has produced a suite of materials to support this regulatory change:
IVD Regulation
Medical Device Regulation