When a company intends to bring its medical device onto the European market it will have to ensure that the appropriate procedures for assessing the conformity with the European medical device legislation have been carried out. The to be followed conformity assessment procedure depend on the intended use and the classification of the medical device itself. The following steps are to be taken to certify your medical device.
- Classification of the medical device.
- Selection of the relevant conformity procedure.
- Drawing up and assessing the Technical Documentation.
- Assessment of the quality system.
- Assessment of the components from suppliers.
- Drafting an EU Declaration of Conformity and affixing the CE marking in a correct manner.
- Registering the medical device with the competent authority.
CE Certification procedure
Medical devices products which are put into use in the European Union must be in compliance with the essential requirements and procedures which are indicated in the applicable medical CE marking Directives.READ MORE
Evaluation of Medical Device products
Evaluation of a medical device is required to determine what European legislation is applicable to the product so that the CE Certification process can be determined. Further, the medical device must be classified according to the applicable European legislation.READ MORE
Classification of Medical Device Products
Classification according to the applicable European legislation is required to determine the exact route to be followed. Our experts can classify your medical device based on the relevant information, i.e. pictures, intended use, general information, user manual and the properties of the product concerned.READ MORE
Quality Management System for Medical Devices
It is mandatory for a manufacturer of medical devices to have a quality management system. A quality management system entails that you have implemented a system which ensures that all the, in series produced, medical devices are of equal quality. CE Medical can assist your company with the implementation of such a system.READ MORE
CE Marking Costs
The certification procedure which is applied determines the costs involved. This is based on the intended use and the classification of the medical devise product. What influences the costs are the directive or directives which must be taken into account, what standards should be used for testing or evaluation. Must a third party be taken into account for evaluation.READ MORE