(EU)2021/2226 explained: Electronic Manuals for Medical Devices
(EU)2021/2226 explained: Electronic Manuals for Medical Devices – published on cemarking.net –
European harmonized standards
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.
Functions and Effects of European Standards: The Final Study
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.
Polish Medical Device Law Renewed
or Poland’s new medical device law will radically change the current environment for doing business in Poland’s medical device sector.
EU Notified Body Medtech Services and How to Overcome the Urgent Shortage: a View from 3 Experts.
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.
EU MDR 2017/745 What Changed?
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?
French & German warning: EU must extend MDR transition period
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.
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.