医疗器械生产商的“QP”：法规第二份草案中的变化

20150812 ECA新闻：医疗器械生产商的“QP”：法规第二份草案中的变化  

GMP News
12/08/2015
"QP" for Medical Device Manufacturers: Changes in the second Draft of the Regulation
医疗器械生产商的“QP”：法规第二份草案中的变化
As a result of the PIP scandal the regulatory basis for medical devices is currently being revised. An article from 2012 (QP for manufacturers of medical devices - new EU requirement?) already covered one of the planned changes in the first draft for a EU regulation: The QP for medical devices. The requirements for this person were already listed in § 13 of the first regulation draft. Now there is a second draft that also comprises changes to the "QP for medical devices".
由于PIP丑闻，医疗器械的法规现在正在进行修订。2012年中的一个条款其实已经包括了所要做的EU法规第一份草案中诸多变更中的一个，即医疗器械的QP。该人员的要求已经在第一份法规草案第13章进行了规定，现在第二份草案中又包括了对“医疗器械QP”的一些变更。
Interestingly, the term "Qualified Person" has been shortened by "qualified" in the second draft of the regulation. However, the draft still comprises qualification requirements, and the scope of activities has even been expanded. According to article 13, medical device manufacturers should have at least one "person responsible for regulatory compliance activities" (so the current name) within their organisation, who is expected to have expert knowledge in the area of medical devices.
有意思的是，术语“授权人”在法规的第二份草案中已经被简化成了“授权”。但是，草案还是包括了资质的要求，而活动范围则被扩大了。根据第13条，医疗器械的生产商在其组织内应有至少一个“人员负责法规符合性活动”（目前的名称），这个人要具备医疗器械领域的专家知识。
Qualification requirements are:
University degree or equivalent degree in natural sciences, medicine, pharmacy, engineering, or other relevant (new: scientific) disciplines and at least two years professional experience in the field of "Regulatory Affairs" or quality management related to "devices" (previously: "medical devices")
资质要求为
大学学历或相当的学位，专业为自然科学、医学、药学、工学或其它相关（新：科学的）学科，具备至少2年“法规事务”方面专业经验，或与“器械”相关的质量管理经验（之前是“医疗器械”）。
Or 或者
five years professional experience in the field of "Regulatory Affairs" (new: related to devices) including (omitted is: or) quality management.
五年“法规事务”领域（新：与器械相关）专业经验，包括（省略的词：或）质量管理。
There are exceptions regarding the qualification for manufacturers of custom-made medical devices that now are not generally exempted any more from the obligation to have a "QP". Another new part defines that micro and small enterprises are not supposed to have that person in the company - but they have to have access to such a person permanently and continuously.
关于生产定制医疗器械的生产商的资质也有要求，现在都不能免除有一个“QP”的要求。另一个新的部分是定义了在公司里不需要有授权人的小微企业—但是他们还是必须可以永久地持续使用这样的一个人。
In addition to the previously mentioned responsibilities
除了上述职责外，
that the technical documentation and the conformity assessment are to be confirmed and kept up to date
技术文件和符合性评估是进行确认并保持更新
that the reporting requirement according to article 61-66 (vigilance) is satisfied
要根据61-66条（警戒）进行报告
that in clinical trials of medical devices there was a 'statement' to point 4.1 of chapter II of annex 14
医疗器械临床试验中，在附录14第II章和4.1点中给出了一个“声明”
the following part has been slightly modified (changes marked in bold)  以下部分进行了很小的修订（变更以粗体标出）
that the conformity of the medical device has been checked according to the QM system forming the basis for the manufacture before the product (so far: batch) is released
在放行前，要根据生产所依据的QA体系检查医疗器械的符合性，
Entirely new is the responsibility in the second draft of the regulation
法规第二版本草案中的职责是全新的
that the post marketing surveillance obligatiopns are met in accordance with article 8 (7)
上市后监管责任要遵守第8（7）条
Separate qualification profiles for "QPs" are called for "authorised representatives".
对“QP”的单独资质要求被称为“授权代表”。
Conclusion: The original "qualified person" person was now renamed in the second draft of the regulation. Perhaps the renaming is supposed to demonstrate a greater difference to the Pharma-QP? The range of tasks has been expanded to post-marketing vigilance activities. The specifications are still just a draft. It will be interesting to see what the actual implementation will look like in the final regulation.
结论：原来的“授权人”现在在第二版本草案中重新进行了命名。或许重新命名是为了表示其与药品QP有更大差异？任务的范围扩大到了上市后监管活动。规范还只是一个草案。看看最终实施的法规会是什么样可能会很有意思。
You can find the full text at Proposal for a Regulation of the European Parliament and of the Council on medical devices and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009
在上述网址中可以找到全文。

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