De Boelelaan 1108
1081HZ Amsterdam
The Netherlands
info@microbiome.nl
ISO certified
Nederlands English

About us

Microbiome is leading in the field of innovative molecular microbiological diagnostics. read more >

Contact

If you have any questions or comments regarding Microbiome products or this Web site, please contact us.

CE/IVD registration

CE Marking is required for most in vitro diagnostic (IVD) devices sold in Europe. CE Marking indicates that an IVD device complies with the European In Vitro Diagnostics Directive (98/79/EC), and that the device may be legally commercialized and distributed in the EU.
If you are looking to obtain CE Marking for an IVD, Microbiome can assist you with several aspects of the process.

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.

E info@microbiome.nl
T 020 - 444 83 07
 

 


Latest news

An Ebola vaccine gave 100% protection in a trial — and that's a great sign for the next outbreak

LONDON, Dec 23 (Reuters) - A vaccine developed by Merck is the first shown to be highly effective in preventing human infection with Ebola, according to... read more >

Best Budget Sun Cream - Altruist Sunscreen

 This is a blogpost from www.reallyree.com. ''Having lived in Australia for ten years in my thirties, I knew many, many people in their 30s and 40s... read more >

Partners of Microbiome

We develop integrated solutions together with leading manufacturers from the diagnostics and pharmaceutical industries, helping them to leverage our leading sample & assay technologies as part of their own offerings... read more >