29 12月 Transition of PPE Directive 89/686/EEC to PPE Regulation (EU) 2016/425

Transition of PPE Directive 89/686/EEC to PPE Regulation (EU) 2016/425

 

Until 20th April 2018

  • The PPE Directive 89/686/EEC is valid without any restrictions!
  • New EC Type Examinations and extensions of already existing EC Type Examinations can only be issued according to PPE Directive.
  • It will be mandatory for Category III products to make a contract according to Annex VII (product inspection) or VIII (production inspection) with the entity responsible for inspection.

 

Note: We advise not to produce and store too many user manuals and packaging materials, as these have to be updated according to Regulation (EU) 2016/425 (e.g. Declaration of Conformity, number of the inspecting entity)!

 

From 21st April 2018

  • Production: The Regulation (EU) 2016/425 is valid!
  • New products are certified according to the Regulation.
  • Hearing protectors are now classified as Category III and no longer as Category II.
  • The Declaration of Conformity according to Regulation has to be issued and published (user manual / internet) also for products which are still produced. It has to contain all relevant directives and regulations.
  • EC-Type Examination Certificates according to Directive 89/686/EEC will not be amended before the expiration date. They are a basis for the new Declaration of conformity according to Regulation (EU) 2016/425.
  • Products in stock, which were produced before 21st April 2018, can continue to be sold.

 

Note: The same applies to PPE imported to the EU!

  • Contracts with Notified Bodies according to Annex VII or Annex VIIImust be available.
  • If inspection controls were agreed upon according to Annex VIII, such a production control must have been carried out.
  • Traders have now the full responsibility for a product, not only the manufacturer or the importer (market surveillance).

 

From 21st April 2019

  • Products which are already put on the market and which were produced or imported before April 2018 can be sold until 2023.
  • EC-Type Examination Certificates according to Directive will still be valid until their expiration date. Certificates without an expiration date will be invalid in 2023.
  • Product inspections according to Annex VII must have been conducted.

 

 

 

中文对照翻译部分:

 

(EU)2016/425PPE规则中89/686/EEC指令的变化

 

到2015.04.20之前

指令 89/686/EEC的有效性没有任何限制

新的CE实验和现有的CE实验只能根据PPE指令来完成

第三类产品必须根据附录7或8来与检验单位订立合同

 

注意:我们不建议生产和储存过多的用户手册和包装材料,这些都必须按照(欧盟)规定来完成(如符合性声明,样品的数量)

 

从2018.04.21起

  • 产品:规定(EU)2016/425生效
  • 新产品的认证按照规定
  • 听力保护产品现在被归为第三类,不再属于第二类
  • 符合性声明根据规定,必须被发布和出版(用户手册/互联网),另外产品也仍然要生产。它必须包含所有的指令和法规。
  • CE证书根据指令89/686/EEC,不会在证书到期之前修改
  • 他们是依据按照(欧盟)2016/425规定新的符合性声明。

 

产品的库存,在2018年4月21日之前,可以据需销售。

注:这同样适用于PPE进口到欧盟

  • 与发证机构的合同根据附录7或附录8必须是有效的。
  • 如果检查组同意根据附录8,这样的生产控制必须被执行 。
  • 贸易商现在拥有一个产品的全部责任,不仅仅限于制造商或进口商(市场监管)

 

 

 

从2019.04.21起

 

  • 在2018年4月以前产品已经投放市场,并且已经被生产或者出口的能出售到2023年。
  • CE证书在其到期之前仍然有效,而没有截止日期的将在2023年到期。
  • 产品检验必须根据附录7来进行管理。
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