Technical file preparation for IVD companies
As part of the CE Marking approval process, IVD manufacturers must compile a technical file showing compliance with Directive 98/79. Your IVD technical file must include information such as your device’s design, intended use, risk assessment and route to conformity with Directive 98/79 requirements. Once completed, it must be made available to European Competent Authorities upon request.
Microbiome can help you register your IVDs in Europe
We have helped multiple companies successfully compile European technical files and can ensure your IVD assays are compliant with EU regulations.
As part of our European IVD registration services, Microbiome can:
- Determine necessary elements such as specific testing required for your device
- Identify which standards will apply to your IVD assay
- Review your existing documentation to determine if any Essential
- Requirements of 98/79/EC have already been met
- Identify and address any gaps in your current Technical File documentation
Once you have successfully gone through the IVD CE Marking certification process, Microbiome can also assist you in developing vigilance and post-market surveillance procedures.
We can also produce IVD assays for European and other markets.
Please contact us to learn more about our CE consulting services in support of European IVD CE Marking.
T 020 - 444 83 07