Trainings for Manufacturers

EU Regulatory frameworks for medical devices and in-vitro diagnostics are continuously evolving.

We have learned that a comprehensive understanding of the CE marking requirements plays a key role in providing a successful and sustainable product-to-market process.

Explore Our Information Platform is the regulatory information platform on medical devices and in vitro diagnostics medical devices. The platform is an indispensable tool for manufacturers to stay up to date about the latest regulatory updates and have all necessary documents on MDR and IVDR at one place. is also the place where you will find answers to your questions and doubts about the compliance process in the European Union and United Kingdom.


Experience Our In-House Trainings

Understand the general framework of the EU MDR and learn about classification rules, conformity assessment routes and technical file requirements. Address the essential requirements for in-vitro diagnostic devices and guarantee CE-marking of your devices under the EU IVDR. Please find below some examples of our training sessions:

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Our team of lawyers, chemists, pharmacists, and other experts represents the largest centre in Europe for CE Marking and EC REP services. Founded in 1988, Obelis is certified by ISO 9001:2015 and ISO 13485:2016, and partakes in various EU associations and EU commission working groups.
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