Your Definitive Guide to CE Marking
For the last 20 years, there has not been a single week in which I have not been asked the following:
“How much does CE certification cost?”
It is a very understandable question. I am sure that it is on your mind as well. Before you start the process of getting the CE marking, it is good to have an overview of the costs involved. But most people do not realize how difficult it is to answer this question.
IVDR Guidance Published Until Eudamed is Fully Functional. Read a short summary here and find the link to the publication
Ecodesign of energy-using products: the UK market versus the Northern Ireland market. There are some differences in the rules for Great Britain and Northern Ireland. Read more here.
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 – published on cemarking.net –
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.
In 2021, the European Commission published its roadmap for a new standardization strategy. The aim of the new strategy is to address the challenges facing the European standardization system. During an 18-month period, different categories of stakeholders from EU and EFTA Member States were consulted as part of this roadmap. The main results are now published in this study.
New IVDR Notified Body in Slovakia: 3EC International has been approved to undertake IVDR conformity assessments.