医疗器械调节的当前位置
美学设备
该报告指出，15项作业赞成在医疗设备监管范围内纳入审美设备。五项任务对此冲突，特别是在理由下，这将在竞争权当前发展金融和行政负担。
吞食产品
医疗器械的想法提供了将某些物质或旨在摄取，吸入或施用直肠或阴道（“摄入产品”）的物质的某些物质或混合物中的物质中的物质中的某些物质或混合物中的调节范围。
It similarly offers that every one of these gadgets can be categorized as high-risk devices (Class III). A compromise has been made on this location is given that the numerous delegations expressed worries at the suitability of the concept, mainly with regards to the delimitation between medical devices & medical products. However, it became commonly recognized that such products could not fall outside the scope of both medical products and medical devices law.
重用一次性设备
费用为reprocessin提供政策建议g of single-use gadgets to make them appropriate for similarly use within the Union. The presidency believes that a compromise proposal that permits the Member states to restrict re-processing underneath national laws but gives that if not prohibited re-processing must observe minimum harmonized regulations may want to find aid from a wide majority.
独特的设备识别系统
委员会提案规定了制造商使用独特的设备识别（UDI）的设备，这允许可追溯性。重要主题包括系统的功能和要求的性质和范围。
特定高风险设备的检查机制
几乎所有提案都包含委员会决定的检查过程是不可能申请的。许多作业辩论，不需要在市场上放置设备前的检查机制。在另一边，一些任务希望增加市场前检验机制。
临床检查
工作组会议目前正在进一步融合关于医疗产品的临床试验的权利和程序原则的规定。
专家团队和参考实验室的作用
虽然大多数作业都接受了（IVD）在体外诊断中的这种实验室的要求
医疗设备为了比较预期测试的力量，一些代表团认为其他医疗设备的要求相同。
有些公司在这项新的医疗设备监管期间期待着。这提供了许多清晰度和答案与新挑战相关的查询。除小公司外，这通常是极端的替代挑战。To study their technical documentation, to appreciate the new policies, to invest in consultants to do the upgrade. We hear a few who need to sell their enterprise to a larger company as that is an excessive amount of their budget. Large Medical Device companies push them to all healthcare organizations.