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Your Definitive Guide to CE Marking

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    • What is CE marking?
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cemarking.net
  • Start Now
  • About
  • Customers
  • Blog
  • More +
    • What is CE marking?
    • Benefits of CE marking?
    • Does your product need CE?
    • Can you do CE marking Self-Certification?
    • Which countries require the CE mark?
    • What does CE certification cost?
    • Who is responsible for CE marking?
    • Amazon Responsible Person for CE-marked products
    • CE Marking Directives and Regulations
    • Technical File
    • EU Declaration of Conformity

CE Directives

Information about the various CE marking directives

IVDR Guidance Published Until Eudamed is Fully Functional

IVDR Guidance Published Until Eudamed is Fully Functional; read more here

IVDR Guidance Published Until Eudamed is Fully Functional. Read a short summary here and find the link to the publication

German Objection Machinery Directive 2006/42/EC

German objection Machinery Directive

The Federal Republic of Germany filed an objection that specifically addresses two standards included in the Machinery Directive

(EU)2021/2226 explained: Electronic Manuals for Medical Devices

(EU)2021/2226 explained: Electronic Manuals for Medical Devices

(EU)2021/2226 explained: Electronic Manuals for Medical Devices – published on cemarking.net –

Harmonized Standards Toy Safety Directive: Important Validation Announcement

Harmonized Standards Toy Safety Directive: Important Validation Announcement

The validation date of some of the harmonized standards under the Toy Safety Directive has been exceeded. This article refers to an outline of the changes for your convenience.

Irish NSAI Expects Approval to get EU MedTech Certification

Irish NSAI expects approval to get the EU MedTech Certification to carry out certifications under new EU criteria for medical equipment.

The Irish NSAI expects approval to get the EU MedTech

Amendments Machinery Directive 2006/42/EC

Amendments Machinery Directive 2006/42/EC. An EU Update of harmonized standards under the Machinery Directive.

New amendments to the harmonised standards of Machinery Directive 2006/42/EC are published in an executive order on April 7, 2022.

Amendments EMC Directive (2014/30/EU)

Amendments EMC Directive: new amendments to harmonised standards published on April 7, 2022

Amendments EMC Directive (2014/30/EU): the European Commission has recently made

MDCG Addition to IVDR to-do List

MDCG Addition to "IVDR to-do List", official publication of this MDCG news announcement from April 1, 2022. 

MDCG Addition to “IVDR to-do List”, official publication of this

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  • How much does CE certification cost?
  • IVDR Guidance Published Until Eudamed is Fully Functional
Get Started With CE Marking

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  • Start Now
  • About
  • Customers
  • Blog
  • More +
    • What is CE marking?
    • Benefits of CE marking?
    • Does your product need CE?
    • Can you do CE marking Self-Certification?
    • Which countries require the CE mark?
    • What does CE certification cost?
    • Who is responsible for CE marking?
    • Amazon Responsible Person for CE-marked products
    • CE Marking Directives and Regulations
    • Technical File
    • EU Declaration of Conformity