was created in March 2017 as a public utility project to meet the information needs of the medical devices sector on the new regulatory framework.

Since the beginning, was owned and managed by Ajda Mihelcic. In autumn 2018, ownership has been transferred to Obelis Group with the goal to transform the platform into a reference point for both industry and other stakeholders when it comes to the European MDR and IVDR legislation. gathers reference documents, implementation tools including checklists, guidelines, analysis documents, as well as regulatory updates, all in a single place.

Obelis Group remains committed to raise knowledge and spread information about the European MDR and IVDR – while keeping the Platform quality-driven, neutral or balanced in terms of opinions provided. Greater comprehension of the new law will help economic operators to develop efficiently innovative medical technologies and furthermore increase product safety to the benefit of patients and users.

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