In-Vitro Diagnostic Device Directive (IVD)

Product tests and certifications by TÜV Rheinland enables you to:

• Ensure compliance with legal and regulatory requirements
• Competitively position your products with our independent third party certification
• Reach markets faster with our comprehensive range of testing and assessment services
• Boost confidence in the quality of your IVD devices
• Benefit from years of experience, expertise and global network

As a notified body, TÜV Rheinland can assist companies acquire worldwide approval of medical devices. We offer a comprehensive range of services for assessing the conformity of In-Vitro Diagnostic Devices.

Steps to acquiring certification include:

1. Definition of the Medical Device and Intended Use
As the manufacturer, you define the intended purpose and classification of your in-vitro diagnostic device.

2. Product Design Examination
For products in Annex II, list A: 
Our experts determine whether all of the product design documentation (design dossier) complies with Directive 98/79/EC. At the same time, we define criteria for batch release. If you pass the design examination, our certification body issues an EC design examination certificate.

32. Technical Documentation Review
A technical documentation review is conducted for checking compliance with the directive.

3. Optional Preliminary Audit
We define the scope of this audit based on your needs. Based on the findings of the audit, a detailed report will be issued highlighting areas with weakness.

4. Initial Certification Audit
Phase 1 
We audit your site to determine whether you are eligible for certification or analyze all the required information about the company. This includes a review of your quality management documentation. An audit report will be issued at the end of the phase 1 audit.

Phase 2 
Based on the audit plan provided prior to the visit, our experts will determine whether your company processes comply with the relevant directives and standards. The audit team includes an expert in the appropriate product category or categories. A detailed audit report with findings will be issued at the end of the visit.

5. Certificate/Approval
If the results of the audit are positive, you receive an approval for the conformity assessment procedure. This is followed by a regular surveillance audit every 12 months and a recertification every 5 years.

6. Declaration of Conformity
Once you have successfully completed the audit, you can issue the declaration of conformity for your products and market them with the CE mark, including the ID of the notified body (0197).