The following general steps are usually required to follow CE certification for intestinal hydrotherapy machines. Please note that this is only an overview and the exact process may vary depending on the type and nature of the product, and the directive to which it belongs
Confirmation of the applicable directive: Determine which European directive the bowel machine falls within the scope of the European directive. In the case of medical devices, the directives that may be involved include the Medical Device Directive or the Medical Device Regulation.
Product Classification: Determine the product classification in the European market based on its nature, use and risk level. This helps determine the applicable certification procedures.
Select a Notified Body: Choose and contact a European-accredited, professional certification body that will assess your product's compliance with the relevant standards and regulations.
Appointment of a Notified Body: Sign an agreement with the chosen Notified Body and submit the relevant documents to commission them to carry out the CE marking assessment.
Preparation of technical documents: Preparation of complete technical documents, including product specifications, design documents, test reports, quality management system documents, etc. These documents are the basis for CE marking.
Risk Assessment: Conduct a risk assessment of the product, identify and take the necessary safety measures to ensure that the product complies with European regulations.
Performance Testing: Performance testing is carried out in laboratories that comply with the relevant European standards to prove that the product meets the technical requirements of Europe.
Application for certification: Submit an application for CE marking to the notified body of your choice, providing all the necessary documents and information. Your documents will be reviewed by the Notified Body and an on-site audit may be conducted.
Approval and certification: If your product has passed the assessment, a Notified Body will issue a CE certificate certifying that your product complies with European regulatory requirements.
Update the technical documentation: For any significant changes to the product, ensure that the technical documentation is updated in a timely manner and resubmitted to the certification body if required to ensure compliance.
CE marking: Properly mark the product and product packaging to indicate that the product has been certified and complies with European regulations.