The New Machinery Regulation: At Certification Experts, we strive for the safety of people. Safe interaction with machinery is a key topic in this matter. That is why on this specific day, #bewustveilig2023 (Safety Awareness day 2023 at work), we would like to have a moment to shed light on the new regulation that will […]
We expect many developments within our field of expertise for 2023. These are the main developments of which we are certain that they will impact you. In this blogpost we will briefly explain what changes will occur, how this will impact you, and how we can help you handle them. You can expect more detailed […]
In China, the National Medical Products Administration (NMPA) – previously the China Food and Drug Administration (CFDA) is responsible for pharmaceuticals and medical device regulations. Similar to the United States, medical devices are classified into three classes (from I to III), which are based on potential risk. When placing medical device products onto the Chinese marketplace, a number of things must be taken into consideration.
Placing products on the United States marketplace can be rather complicated when it comes to safety and compliance. In relation to electronic products, some aspects are covered by regulations and mandatory standards, while other aspects – including electrical safety – are covered by what is known as ‘voluntary’ safety standards. If you are a company wishing to sell products in the United States, this overview may be useful to refer to.
The Machinery Directive (also known as Directive (EU) 2006/42/EC) exists to establish a regulatory framework for placing machinery on the Single Market of the European Union. During the ‘REFIT’ evaluation of the Directive, stakeholders confirmed that this legislation, while important, contains a necessity to improve and adapt to the needs of the market. The revision was listed in the European Commission’s 2020 Work Programme.
Robotics is a complex topic that requires the finest attention to detail in terms of ensuring compliance standards are met in any market. The European Commission has developed standards specifically relating to different types of robots, and it is important that manufacturers ensure they are meeting the correct standards for the type of robot they wish to put onto the market. We have simplified some of the information for you in this article.