(EU)2021/2226 explained: Electronic Manuals for Medical Devices
(EU)2021/2226 explained: Electronic Manuals for Medical Devices – published on cemarking.net –
Your Definitive Guide to CE Marking
(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.
or Poland’s new medical device law will radically change the current environment for doing business in Poland’s medical device sector.
Three well-known notified body experts discuss how they are trying to make the new regulatory framework work as demand for EU notified body Medtech services rapidly outpaces capacity.
The new medical device regulation, EU MDR 745/2017, has several additional criteria in regard to previous legislation. This new regulation also has a stronger connection to EN ISO 13485:2016. What modifications have been made to the prior medical device regulation, and how must you implement these changes in your current quality management system?
The French and the Germans warn: The EU must extend MDR transition period. This comes following a meeting with European Commission representatives in Paris on March 14, 2022.
New amendments to the harmonised standards of Machinery Directive 2006/42/EC are published in an executive order on April 7, 2022.