CE Marking For Medical Devices
If you product falls within the scope of the Medical Device Directive 93/42/EEC or the Medical Device Regulation (EU) 2017/745, it is legally obliged that the product bears the CE mark. By affixing the CE mark on a medical device, the manufacturer indicates that the medical device complies with the applicable legislation. It is the responsibility of the manufacturer that the medical device bears the CE mark. In order to comply with the applicable legislation the Technical Documentation shall be drawn up and, if applicable, a quality management system shall be implemented.
The experts of CE Medical can fully organize the conformity assessment procedure for your company in order to CE mark your device. Organizing the conformity assessment procedure comprises of:
- Classification of the medical device.
- Determining the correct conformity assessment procedure.
- Evaluating the available Technical Documentation.
- Guidance to draw up and complete the Technical Documentation.
- Evaluating the available quality management system.
- Guidance to implement a quality management system in accordance with the legislation.
- Correspondence with the Notified Body.
Contact one of our experts now to discuss the CE marking of your medical device.
Benefits of working with CE Medical.
- Experience in the world of certifying medical devices.
- Independent guidance through the entire certification process.
- We will communicate with Notified Bodies on your behalf.
Who is CE Medical?
As an international organization we have over 25 years of experience specializing in guiding companies in obtaining CE-marking for their Medical Device Products. The history of CE Medical goes back to the early nineties when the Certification Experts group was founded and were market leaders in the CE certification for different type of products.
In 1997 CE-Medical was founded and over the years we have developed international expertise for the certification of medical devices. Due to the ever increasing requests for our professional expertise CE-Medical has grown and it has developed itself as an separate successful entity.