If you want to market in-vitro-diagnostic medical 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.
Product tests and certifications by TÜV Rheinland enable you to:
As the manufacturer, you define the intended purpose and classification of your in-vitro diagnostic medical device.
1. Voluntary pre audit.
We will base the scope of the pre audit on your wishes. You receive a report that can provide you with important information for the preparation of the certification audit.
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.
3. Technical Documentation Review
We review your technical documentation for compliance with the directive.
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 audit results are positive, the decision on granting certification and issuing the certificate will be performed by a person independent from the audit (certifier). This is followed by a regular surveillance audit every 12 months and a recertification every 5 years. Additional unannounced audits will be performed in irregular intervals.
Did you know? Neither a decision on granting certification nor any change of the certificate status (e.g. maintaining, renewing, refusing, suspending, restoring or withdrawing certification as well as expanding or reducing the scope of certification) is made by a single person! We always apply the four-eyes principle: The evaluation of the audit team/product expert is followed by a separate review and decision.
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).
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
List B in Annex II: Reagents and Reagent Products, including Related Calibrators and Control Materials
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.