{:en}New Regulation Proposal: 542/2012 Compliance{:}{:zh}新法令提案:542,2012 承诺{:}

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On April 2nd, 2014 the European Parliament adopted a resolution introducing 347 amendments to the European Commission’s proposal for a new Regulation on medical devices. This resolution introduces the amendments that were initially voted on 22 October 2013 on first reading of the Commission’s proposal.

In accordance with the co-decision procedure, the text is now under review of the Council for 1st reading. At this stage, 2 outcomes are possible:

    • The Council may side with the Parliament’s position, in which case the legislative act will be adopted;
    • The Council may amend the text adopted by the Parliament’s, and return the proposal to Parliament for a 2nd reading.

When the new text will be adopted, medical manufacturing companies will have to make sure they are in compliance with new CE marking requirements in order to lawfully affix the CE mark.

The key amendments introduced by the European Parliament to the Commission’s proposal for a new Regulation on medical devices are:

    1. Introductions of rules concerning the reprocessing of single use devices: all medical devices are to be considered reusable and suitable for reprocessing by default. Only devices that will be defined by the Commission as being ‘unsuitable for reprocessing’ may be single use.
    2. Involvement of the Special Notified Bodies in the conformity assessment procedures of high-risk devices (e.g. class III and implantable devices) that would be designated by the European Medicines Agency (EMA).
    3. Introduction of medical devices for aesthetic purposes within the scope of the proposal for a Regulation on medical devices.
    4. The Unique Device Identification system proposed by the Commission was endorsed by the Parliament.
  •  Introduction of a prior approval by competent authorities in order to prove conformity with general safety and performance requirements by other means than clinical data. The possibility to use non-clinical testing methods to prove conformity is restricted to low-risk devices.

 

It is still unsure whether the Council will support the above-mentioned points. Obelis, in its role of European Authorized Representative, is constantly watching legislative developments so as to make sure to provide medical manufacturing companies with the best advisory services on CE marking.


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{:}{:zh}2014年4月2日,欧洲议会通过了一项决议,对欧盟委员会提出的关于医疗器械新法规的347项修正案提出了建议。这项决议介绍了于2013年10月22日最初投票的委员会建议的修正案。

根据联合决策程序,文案现在已在进行理事会的初次审阅。在这个阶段,有2个结果是可能的:

  • 该理事会可能会与议会的立场相同,在这种情况下,立法行为将通过;
  • 委理事会可以修改议会通过的文案,并将提案交还给议会,进行第二读。

 

当新的文本将被采用时,医疗制造公司必须确保他们符合新的CE标志要求,以合法地贴上CE标志。

由欧洲议会向理事会提出的新的医疗器械法令的关键修改包括:

A.介绍关于一次性使用设备再加工的规则:所有的医疗设备都被认为是可重复使用的,并默认适用于再加工。只有被委员会定义为“不适合再处理”的设备可能是单次使用。

B.参与高风险设备(如III类和植入设备)合格评定程序的特殊公告机构将由欧洲药品管理局(EMA)指定。

  1. 在此医疗器械法令的规定范围内的美容用途医疗器械使用此法令。
  2. 由理事会提出的独特的设备识别系统得到了议会的支持。
  • 引进除了临床数据以外的,经主管机关事先批准,以证明符合一般的安全和性能要求的其他方式。使用非临床试验方法,以证明符合性的可能性被限制使用于在低风险的设备。

 

现今仍不确定理事会是否会支持上述观点。obelis,作为欧盟授权代表的立场,不断观察立法的发展,以确保提供医疗制造企业关于CE标志最好的咨询服务。


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in Medical Devices Directive