Launch Procedure for Medical devices regulation

Some key elements of the new medical devices regulation include:

• 扩展医疗设备的定义：The broadness of medical devices has been essentially extended and incorporates certain products which recently did not fall under the meaning of a medical device. For instance, eye contact lens solution, liposuction equipment and laser equipment used for hair and tattoo clearance.
• Enhanced vigilance and market surveillance：当可以在市场上使用小工具时，制造商将有义务收集有关其绩效的信息，欧盟国家将在市场监视领域更加专注。新法规将保证不可或缺的数据，通过更严格的可追溯性措施很容易找到。例如，患者将收到带有所有基本数据的植入卡，并且每个项目都必须使用唯一的设备标识符。
• Eudamed数据库：The Commission will set up a centralised EU database for the capacity of data on medical devices (EUDAMED). This will encourage the communication of both pre- and post-approval product data between economic operators, the Commission, member states and, in some cases, healthcare professionals and people in general.
• Tighter regulatory controls：pre-mar将迫使更多严格的新原则ket controls on high-risk devices, and apply an increasingly unbending way to deal with the direction of both clinical evaluation and the clinical investigation of clinical trials. The MDR will require device manufacturers to conduct clinical performance studies and provide give proof of security and execution, proportionate with the risk associated with a given device. EU cross-border clinical trials will be subject to a single coordinated assessment. Stricter requirements on the use of hazardous substances will also be introduced, and device manufacturers will be required to collect and retain post-market clinical data, as part of the ongoing assessment of potential safety risks.
• Introduction of a risk-based classification system：一个new system for risk classification, in line with international guidelines, will apply to in-vitro diagnostic medical devices, in addition to a wider medical device classifications definition for all products. While the classification system (Class III, Class IIa, Class IIb and Class I) will be retained, some rules have been tightened. This may result in a significant number of product types – previously exempt from the regulations – now being included in the scope. Manufacturers will need to demonstrate that their medical device meets the requirements in the MDR and IVDR by carrying out a conformity assessment. The assessment route depends on the type and device classification.
• 市场后监视系统（PMSS）：作为其质量管理系统的一部分，制造商还必须建立一个PMS，该PMSS应与风险类别和有关设备的类型成正比。制造商将不得不向包含相关数据的欧盟门户网站报告所有事件，伤害和死亡，因此患者可以访问与安全有关的信息。
• 再保险sponsible Person (RP)：Medical device manufacturers and authorised representatives will be required to designate at least one person with responsibility for regulatory compliance; that person(s) must hold the prerequisite academic expertise and work experience in the field of medical devices.
• Financial compensation measures must be in place：The regulations require manufacturers to have measures in place to provide sufficient financial coverage in respect of their potential liability. Such financial coverage must be proportionate to the risk class, type of device and the size of the enterprise.

Medical device manufacturers must prepare for regulatory changes

在截至2020年5月的本过渡期间，制造商可以选择遵守现有的MDD/AIMDD立法要求或新的MDR。但是，像所有在欧盟销售的医疗设备产品一样，最终必须遵守MDR，并且在全面应用MDR否定MDD合规性后，对MDD PROD产品的任何更改都建议公司定义其监管过渡的策略。

Comparing and contrasting regulatory differences between the existing MDD and the new MDR is important. As it is highly likely for most legacy devices that a review of MDR requirements will identify regulatory issues that will need to be addressed for every device. Complying with the new MDR will prove a high task for most medical device manufacturers. Guidance and implementing measures under the current Directives will be reviewed by authorities over the next few years, in light of the new regulations.

一个t this present stage, the European Commission has a published list of legally non-binding guidance documents adopted by the Medical Device Coordination Group, to support the industry’s efforts to apply relevant provisions of the MDR. These include consensus statements, informative documents and MEDDEVs for medical device manufacturers, authorised representatives, notified bodies, and competent authorities.

In addition, on October 30, 2018, the European Commission published the most recent version of the Borderline & Classification Manual. This document provides guidance on establishing the status of medical devices and IVDs, as well as their risk classifications. The current version, version 1.20, replaces version 1.19 released in April 2018. The new medical device regulations in Europe present a huge challenge to manufacturers, but could also deliver improved confidence in the consistency and effectiveness of the EU regulatory process.

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