In-Vitro Diagnostic Medical Devices Directive
TÜV SÜD Product Service is the largest Medical Device Notified Body, with accreditation for all medical devices and all conformity routes. With over 50 offices worldwide, we provide a professional and responsive service to assist clients in bringing their products to market in compliance with international, national and voluntary requirements.
We can perform:
- conformity assessment processes for all products pursuant to the IVD Directive (In Vitro Diagnostic Directive)
- laboratory tests (electric safety, mechanical safety, performance tests), as an extended workbench for manufacturers
- assessments of the functional safety of in vitro diagnostics by collaboration with external cooperation partners
For special questions, particularly relating to the following product examples, please contact our experts.
- HIV tests
- Hepatitis tests
- Blood grouping tests
- Pregnancy tests and more...
Benefits of using TÜV Product Service for Medical Device Service |
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