CE Marking
A mandatory certification mark in the European Union indicating that a product meets health, safety and environmental protection requirements. Once obtained, the product may circulate freely in the European Economic Area, and medical devices must be assessed by a notified body.
Timeline (last 90 days)
Robot safety certification cycles can last months or even more than a year, global deployment requires repeating the certification process in different markets, and compliance costs can account for a considerable proportion of the total product development budget.
The Prima system obtained European CE certification in July and can be marketed and sold within the EU.
CE certification is the EU's mark that a product meets health, safety, and environmental requirements, and obtaining CE certification means the product can circulate freely in the European Economic Area.
The EU regulates wheelchairs under MDR (Medical Device Regulation 2017/745), requiring manufacturers to complete CE certification and establish a post-market surveillance system.
All Facts (4)
Robot safety certification cycles can last months or even more than a year, global deployment requires repeating the certification process in different markets, and compliance costs can account for a considerable proportion of the total product development budget.
50%UnverifiedCE certification is the EU's mark that a product meets health, safety, and environmental requirements, and obtaining CE certification means the product can circulate freely in the European Economic Area.
50%UnverifiedThe EU regulates wheelchairs under MDR (Medical Device Regulation 2017/745), requiring manufacturers to complete CE certification and establish a post-market surveillance system.
50%UnverifiedThe Prima system obtained European CE certification in July and can be marketed and sold within the EU.
50%