What does CE Marking cost
The costs for certification of medical devices are dependent on the intended use, the applicable legislation, the applicable standards, the classification and on the fact whether a third party notification is required.
Based on relevant information on the product, the medical device certification experts at CE Medical can indicate the costs and procedures involved for the certification of your medical device.
For fast processing of your request to provide you with an accurate price indication and timeframe, we require the following documentation of the product;
- A picture of the medical device that has to be certified.
- A general description of the medical device including the intended use.
- The specifications of the medical device.
- If available, test reports of the tests that have been carried out and certificates and other relevant documents.
The expertise of CE Medical is based on a combination of practical and theoretical knowledge in medical device certification, medical device safety, design engineering, quality assurance, technical documentation and the use of accredited test facilities. Our legal department covers all aspects of product liability and the legal consequences that arise from the European legislation for medical devices.
Aspects such as practical classification, determining the most efficient certification procedure, evaluation and verification of technical documentation, the compiling of technical documentation, ensuring correct testing of products, evaluation by affiliate notified bodies and registration of medical devices at the national authorities fall within the services of CE Medical. CE Medical will conduct the services in a custom made manner for any medical device.
The experts of CE Medical use their in-house experience to conduct the conformity assessment procedures to ensure the compliance of your medical device with the European medical device legislation in an efficient and cost effective way. As a result you can legally affix the CE mark on your medical device.Leave a reply