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【奥译言】欧盟通过新法规，确保医疗器械安全性（三）

对于某些高风险器械，新法规要求公告机构在器械上市前咨询专家小组。根据这一程序，专家小组可以就公告机构对制造商的临床文件评估向其提供科学的意见。虽然公告机构不受专家组意见的约束，但必须对其不采纳意见进行论证。有关意见的所有相关文件及公告机构的最终决策将于EUDAMED公开发布。 

医疗器械行业是全球领导者和欧洲的主要雇主：拥有超过25,000家企业，雇佣超过50万人。该行业以中小企业（SME）为驱动力，新法规使其在复杂的全球环境中更具竞争力、更可靠，促进欧盟企业在全球范围内保持并进一步扩大其领导作用。原因在于以下三个要素：

? 行政程序的简化 - 在新框架下，器械和经营者仅需在欧盟层面进行一次注册。与今天的情况相比，这是一个重大变化，因为在许多情况下，制造商可能需要在其产品上市的所有成员国注册其产品。

? 增加法律的确定性 - 增长和竞争力建立在一套稳定的法律条件之上。与指令相反，法规直接适用于所有成员国：这将有助于避免患者和行业在不同国家存在不同条件的情况。新法规还包括了对新条例范围的准确和详细的说明，并列出相关经济经营者的明确义务，以及适用于某些器械或做法的特定豁免制度的表述，如内部器械或一次性器械的再加工。

? 提高整体系统的可信度和声誉 - 行业的信誉对整个欧盟医疗器械系统的信誉高度敏感。有关负责认证和批准医疗器械的公告机构“不公平对待”的各种事件和公开报告已经损害了患者和医疗保健人员对他们每天使用的器械安全性的信心，同时也证实了现今立法的薄弱。新法规对现行立法的缺陷进行了探讨，力求提高对医疗器械市场的整体信心。

这些优势将抵消企业因遵从新法规更高的安全标准和新要求而产生的额外成本。法规还提到了中小企业的特殊需求，特别是对制造商的财务保障、负责法规合规性的人员以及公告机构的收费的新要求。这将给活跃在这个行业的中小企业带来无形的帮助。 

有些器械在一次性使用完毕后必须丢弃。然而，在适当控制的条件下，某些此类器械可以安全地重复使用。医疗器械法规包含对一次性医疗器械再加工的最低要求。再加工只能在国家法律授权的情况下进行，并按照医疗器械法规的规定进行。当再加工获准进行时，进行器械再加工的单位必须承担与制造商相同的义务。不过，卫生机构和第三方应卫生机构要求进行再加工的情况适用于另外一种制度。这种制度包括按照通用规范和国家规定及经公告机构认证的协调标准进行再加工。

新医疗器械法规为含有纳米材料的器械制定了专门的分类规则。关键因素在于纳米材料是否与身体内部的膜接触。那些具有高度或中度接触可能性的器械将划分为最高风险级别，并将进行最严格的符合性评估程序。

New EU rules to ensure safety of medical devices – Part 3

Source: European Commission Press Release Database
Website: http://europa.eu/rapid/press-release_MEMO-17-848_en.htm

How will the scrutiny mechanism for assessment ofhigh-risk devices work?

For certain high risk devices, the new Regulationsrequire the Notified Bodies to consult with an expert panel before placing thedevice on the market. According to this procedure, an expert panel couldprovide a scientific opinion to the notified body on its assessment of themanufacturer's clinical file. While the notified body would not be bound by theopinion, it would have to provide a justification for not following it. Allrelevant documents regarding the opinion and the final decision of the notifiedbody would be publicly available in EUDAMED.

What will be the impact of the new rules on theindustry? Will they result in additional costs for companies and SMEs inparticular?

The medical devices sector is a global leader and amajor employer in Europe: it employs more than 500,000 people in over25,000companies. The sector is driven by small and medium-sized companies(SMEs) and the new Regulations will help the EU industry to maintain andfurther expand its leadership role on the global scale, by making it morecompetitive and more solid in a complex global environment. This will be theresult of three main factors:

• simplified administrative procedures - under the new framework, registration of     devices and operators will have to be done only once at the EU level. This     is a major change compared to today's situation where in many cases     manufacturers might be required to register their products in all Member     States where those products are placed on the market.
  
  

• increased legal certainty - growth and competitiveness build on the     existence of a stable set of legal requirements. Contrary to a Directive,     a Regulation is directly applicable in all Member States: this will help     to avoid varying conditions for patients and industry in different     countries. The new texts also include precise and detailed clarifications     of the scope of the new rules, a list of clear obligations of relevant     economic operators as well as an indication of the specific exemption     regimes which apply to certain devices or practices such as in-house     devices or reprocessing of single-use devices.
  
  

• increased credibility and reputation of the overall system - industry's reputation     is highly sensitive to the credibility of the EU medical device system as     a whole. Various incidents as well as public reports regarding an alleged     “uneven approach” among the bodies responsible for certification and     approval of medical devices have damaged the confidence of patients and     healthcare professionals in the safety of the devices they use every day,     while confirming some weaknesses in today's legislation. The new     Regulations address the shortcomings of the current legislation and aim to     increase the overall confidence in the medical device market.
  
  

These advantages should counterbalance the extra costsincurred by companies due to compliance with the higher safety standards andnew requirements contained in the new Regulations. Specific needs of SMEs havebeen addressed in the texts particularly in relation to new requirements onfinancial coverage for manufacturers, person responsible for regulatorycompliance and fees charged by Notified Bodies. This gives a potential boost toSMEs active in this sector.

What are the rules on reprocessing single-use medicaldevices?

Some devices are intended to be discarded after theyhave been used once. However, under properly controlled conditions some suchdevices can be safely reused. The regulation on medical devices containsminimum requirements on reprocessing of single-use medical devices.Reprocessing may only take place when authorised under national law and inaccordance with the provisions of the medical devices Regulation. Whenreprocessing is allowed, the entity that wants to reprocess the device mustassume the same obligations as a manufacturer. However, a different regime isapplied in the case of reprocessing by health institutions and by third partieson the request of health institutions. Such regime includes compliance ofreprocessing with common specifications or national provisions and harmonisedstandards to be certified by a notified body.

Is the regulation addressing the issue of risks of useof nanomaterials used for medical devices?

The new Regulation on medical devices lays down adedicated classification rule for devices incorporating or consisting of nanomaterials.The critical factor is the potential for nanomaterials to be in contact withmembranes inside the body. Those devices presenting a high or medium potentialfor such contact will fall under the highest risk class and thus be subject tothe most stringent conformity assessment procedures.

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内容来自： European Commission Press Release Database

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