Technical File Review

To sell in the European Union, manufacturers must have and keep up to date the technical documentation for their medical devices. This applies to all manufacturers of medical devices and IVD medical devices, whether based in the EU or not.

The technical documentation has to include all elements relevant for the device set out in the Medical Devices and IVD Medical Devices Regulations (MDR and IVDR) to demonstrate conformity with the applicable Regulations.

A compliant technical file is a key aspect when aiming to obtain the CE marking for the European markets.

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Compliance Success Stories

Why Obelis?

Our deep and long-standing experience with Swiss, EU and UK compliance frameworks makes us the best choice to support your products’ path towards compliance in these territories.

Our team regulatory experts will guide you through medical devices’ technical documentation, notification, labelling, among others.

About us
Founded in 1988, we are among Europe’s largest centres for advisory and representative services.
We are certified by ISO 9001:2015 and ISO 13485:2016.
We have helped over 3,000 manufacturers from over 60 countries address their regulatory challenges.
We are members of professional associations and more than 10 European Commission working groups.
Obelis International Offices (OIO) comprise independent partners providing solutions in other global markets.
Our team consists of lawyers, chemists, pharmacists, and other experts. Our close-knit culture has been certified by the Great Place to Work Survey 2022-23.