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AIMD, MDD, IVDD Directives
TUV Rheinland of North America can help you get to market faster. The following steps apply to medical devices in accordance with the AIMD (Active Implantable Medical Device Directive), MDD (Medical Device Directive), IVDD (In Vitro Diagnostic Device Directive) directives.
1. Establishing Contact
First, TUV Rheinland of North America with the Notified Body will introduce you to the range of services of the Notified Body and capabilities and then get to know you, your company and your products. Your needs and further procedures are then determined together. Early establishment of communication, in some cases even in the product development phase, will allow for better coordination of the time schedule for the market launch of your product.
2. Quotation
TUV Rheinland of North America will prepare a quotation for you that covers the requested services in the CE Marking process (QM audit, product testing, examination of the technical documentation, etc.).
3. Order
After receipt of the order, TÜV Rheinland will respond to your questions quickly and coordinate the handling of your project.
Technical Documentation
Prior to product testing or an audit, selected documents from the technical documentation will be checked for plausibility and for conformity with the requirements of the directive.
5. All AIMD, MDD Class III and IVDD List A Products
For examination of the design dossier or EC type-examination: Submit the documentation on the product design (design dossier) to TÜV Rheinland. It will be checked for completeness and plausibility, or the product and the associated documentation will be tested. A report on the test results is then issued. If the assessment is positive, you will receive the following certificates:
- MDD: Annex II.4 or Annex III
- AIMD: Annex II.4
- IVDD: Annex IV.4 or Annex V for List A
- Annex III.6 for IVDD for self-testing
6. Voluntary Pre-Audit
TÜV Rheinland will base the scope of the pre-audit on your wishes. Upon completion of the pre-audit, you will receive a report.
8. Certification Audit
Prior to the certification audit, you will receive the audit plan created with and approved by you. During the audit, your company’s operations will be examined and evaluated to ensure that the requirements of the applicable directive and the relevant standards are fulfilled. During the audit process, TÜV Rheinland will pay particular attention to assess the conformity of your products with the essential requirements and the team of auditors will always include at least one expert on your product category. All relevant production sites are included in the scope of the audit. Upon completion of the certification audit, a detailed report will be issued.
Stage 1 Audit
In the scope of the Stage 1 audit TUV Rheinland evaluates the readiness of the client for the certification audit. It includes a detailled review of the quality manual and relevant procedures, determination of any site-specific condition, identification of processes and objectives, evaluation of the current status of management review and internal audit and over all the level of the implementation of the management system.
9. Certificate/Approval
If the audit result is positive, you will receive an approval for the respective conformity assessment procedure. In follow up, surveillance audits will be performed every twelve months and a recertification audit will be conducted after five years.
10. Declaration of Conformity
You will then be permitted to issue the declaration of conformity for your medical devices, to provide them with the CE Mark including the identification number of the “Notified Body” and to place your
Modular System for Medical Device Certification
