Notified Bodies an overview:
您必须在欧洲联盟推销该设备CE之前先对其进行标记。此外，医疗设备制造商必须服从通知机构对所有人进行的一致性评估，但风险产品（I类）（NB）。
通知机构是第三方组织，已获得欧盟成员国批准，以判断制造商是否遵守相关立法。凭借如此关键的角色，选择一个通知的身体，并且您的伙伴关系的工作关系对于获得CE标记至关重要。188bet金搏宝滚球作为188bet金搏宝滚球CE标记医疗设备顾问，我们知道选择通知身体的关键，因此我们与正确的通知机构合作以获得合规性。
您可以做很多事情来确保您与通知身体的工作关系非常好，并且您的设备在其CE标记方面有望，无论您是刚刚开始选择过程还是深入审计准备。188bet金搏宝滚球
Selection of a Notified Body and their Process:
Not only medical device manufacturer has had to adapt to the new European Union In Vitro Diagnostic Regulation and the European Union Medical Device Regulation (EU MDR) (IVDR). Only 30 NBs have been recognized under EU MDR as a result of the new regulations’ need that Notified Bodies go through a new designation and notification process. And the EU IVDR has only designated seven NBs. Because there are fewer NBs, those who are designated under MDR and IVDR will only be able to handle a certain number of new conformity assessment applications.
当您向NB申请进行合规评估时，您必须将适当的代码分配给设备，并且您的NB必须证明这些代码是否准确。这些代码最初可能看起来具有挑战性，但是提前熟悉它们将帮助您选择适合您特定设备类型的正确代码和NB。
了解您的通知身体的过程
尽管容量和指定可能会限制您可以使用的通知尸体的数量，但确实不应该从拥有的选项中随机选择。
Annex VII, 4.1 of MDR states that Notified Bodies:
应有记录的流程和足够详细的程序，以进行指定的每种合格评估活动，包括从预先应用活动到决策和监视的各个步骤，并在必要时考虑到各自的特殊性设备。
至关重要的是要意识到不同的NB将具有不同的方法。这并不意味着所有NB都遵守MDR和IVDR或多或少。这仅意味着，取决于包括NB的规模，容量和定价计划在内的几个变量，它们的交流方式可能会发生变化，提供服务并与您的组织合作。
The reporting structure of NBs is a good illustration of how they might vary. Your NB will have a recommended format or layout for accepting that submission if you obtain findings or are required to submit a substantial modification notification.
在开始申请或与NB的任何合同参与之前，确定这是否真的是您业务最适合您的业务，通过了解更多有关其既定流程的信息。
Your Quality Plan to address New MDR Requirements in MDR
Two audits will be performed by your Notified Body during the conformity assessment procedure. The Stage One audit is where the NB determines whether or not to move forward with your application by determining your organization’s readiness. The Notified Body wants to know how prepared you are, therefore their purpose throughout this audit is to comprehend your quality system and quality management strategy.
他们将检查以检查您在此审核期间如何处理MDR义务。如果您是已经在市场上的产品的制造商，他们将有兴趣了解您从现在已建立的医疗设备指令（MDD）过渡到MDR的策略。
Recently, Notified Bodies have brought up non-conformances with producers in this area. Frequently, what the manufacturer has done to fulfil the new MDR standards lacks either clarity or specificity.
通知身体的作用：
显示您的通知身体，您了解您的义务
The general obligations of manufacturers are covered by Article 10 of the MDR. The NB will carefully examine how you’re handling these requirements during an audit.
They will want to ensure that you are adhering to the MDR criteria when they examine your QMS structure. For instance, are your risk management, clinical evaluation report (CER), post-market surveillance (PMS), and technical documentation all related?
NB还将研究您如何与不同的经济运营商（EOS）实施合同协议。您是如何处理EOS的MDR要求的？这需要向他们展示您的沟通，程序，供应商审核和其他与合规性有关的活动。
This is not a comprehensive list of questions or things your NB will want to see, but it should make you consider how prepared you are for these types of queries.
将您的网站和营销工作遵守法规
The requirements for MDR can be found in Article7, however manufacturers occasionally are unaware that everything on their website and in their marketing, materials is also subject to its rules.
Your NB will want to confirm that all claims you make about your product are backed up by data.
作为医疗设备监管顾问we help our client in maintaining data and making file of necessary documents needed for the certification. False statements of any kind are obviously prohibited, but so are deceptive pictures that provide the wrong idea about the product or imply a use for it other than what is explicitly intended.
NB将想知道您打算如何保证网站，社交媒体帐户和其他在线平台的内容是准确的，并且符合MDR。他们将要求检查您设置的程序以监视这些外部通信。
