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最新动态
  • Looking for a suitable GMDN-Code?
    MDSS can assist you to determine an appropriate code for your products!
    more


  • MDSS, may support you with the process of applying for a Certificate of Marketability...more


  • Update to IVD Directive...more

  • Update to MEDDEV Guidelines...more

  • Update to Portuguese Registration...more

  • Update to Vigilance Guideline...more

  • Update Harmonized Standards

    EN 980 is back...more



    
展会信息
Keep up to date!

News and Views March 2017

New Medical Device Regulation (MDR) in Europe
Read more...

In-House Workshops
The "NEW CE" mark
Book now!
 to make sure you’re ready to survive and thrive



重要事件
Meet us!

8. Medical Device Networking Meeting
Hanover, April 27, 2017




联系我们
MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

Phone
(+49)-511-6262 8630
FAX
(+49) -511-6262 8633

Click here to
contact us




企业咨询: Consulting


CE商标 (CE marking service)

所有医疗产品在欧盟上市的前提都是要获得CE标志。取得CE标志的第一步是确定产品的种类,然后才能确定需要参照哪个指令 (MDD)93/42/EEC, the Active Implantable Medical Directive 90/385/EEC, In Vitro Diagnostic Medical Device Directive (IVDD) 98/79/EC)。


让MDSS帮助您确定您的产品到底该归于哪一类。有可能您的产品属于边缘产品,它们可能是医药,或者化妆品,或者是抗微生物剂。


在确定产品类别和该使用的指令后,还有下列各项是生产商在发表符合性声明之前必须进行的:
       

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