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
or Poland’s new medical device law will radically change the current environment for doing business in Poland’s medical device sector.
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.
Amendments EMC Directive (2014/30/EU): the European Commission has recently made
