If you want to market in-vitro diagnostic devices in the EU, you need to comply with Directive 98/79/EC on in-vitro diagnostic medical devices. As a notified body for in-vitro diagnostic medical devices (IVDs), we can test and certify your quality management system and products.
Benefits at a Glance
Product tests and certifications by TÜV Rheinland enable you to:
- Communicate your high standards of quality
- Boost confidence in the quality of your IVDs
- Show that you meet legal requirements
- Benefit from fast lead times and our long-standing experience
Tests and Certificates
As the manufacturer, you define the intended purpose and classification of your in-vitro diagnostic device.
1. 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.
2. Technical Documentation Review
We review your technical documentation for compliance with the directive.
3. Optional Preliminary Audit
We define the scope of this audit based on your needs. You receive a report that shows where you need to improve.
4. Initial Certification Audit
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. We provide you with a report on the results.
Prior to the audit, you receive an audit plan. During the audit, we 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. You receive a detailed audit report.
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).
Which products require a conformity assessment by a notified body?
A conformity assessment by a notified body is mandatory for all products specified in Annex II, Lists A and B of Directive 98/79/EC, as well as products designated for self-testing.
List A in Annex II: High-Risk In-Vitro Diagnostic Devices
- Reagents and reagent products, including related calibrators and control materials for determining the following blood groups: ABO system, rhesus (C, c, D, E, e), and anti-Kell.
- Reagents and reagent products, including related calibrators and control materials, for detection, confirmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B, C, and D.
List B in Annex II: Reagents and Reagent Products, including Related Calibrators and Control Materials
- For determining the blood groups anti-Duffy and anti-Kidd
- For determining irregular anti-erythrocytic antibodies
- For detection and quantification in human samples of the following congenital infections: rubella, toxoplasmosis
- For diagnosing the hereditary disease phenylketonuria
- For determining the human infections cytomegalovirus and Chlamydia
- For determining the HLA tissue groups DR, A and B
- For determining the tumoral marker PSA
- Designed specifically for evaluating the risk of trisomy 21 (including software)
- Designed as self-testing devices for measuring blood sugar
IVDs for Self-Testing
Products for self-testing by non-professionals at home (e.g. pregnancy tests or cholesterol tests).
Any questions? Would you like an individual, non-binding offer? Then write to us now. We will respond to your request as quickly as possible.
- Questionnaire for the preparation of an offer for medical products (PDF, 114 KB)
- General Terms & Conditions (PDF, 62 KB)
- Testing & Certification Regulations (PDF, 116 KB)