IVDR Guidance Published Until Eudamed is Fully Functional
IVDR Guidance Published Until Eudamed is Fully Functional. Read a short summary here and find the link to the publication
CE Directives
Information about the various CE marking directives
German Objection Machinery Directive 2006/42/EC
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 – published on cemarking.net –
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
The Irish NSAI expects approval to get the EU MedTech
Amendments Machinery Directive 2006/42/EC
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 (2014/30/EU): the European Commission has recently made
