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June 26, 2020 | Distributor duties, distributor qualifications and quality agreements

Distributors have responsibilities toward making a device available on the market. This article discusses the obligations lying with the distributor and ways for a manufacturer to ensure that a distributor is qualified to meet these requirements.

June 19, 2020 | Importer Duties

The question of whether imported medical devices are required to transit through the importer is a recurrent one. This article aims to clarify this comprehensively, as well as to provide an outlook on the need for quality agreements between the manufacturer and the importer.

June 12, 2020 | Placing on the market, making available, and putting into service

when it comes to determine what activity is done by whom in a distribution chain, one can struggle to get a clear picture of the delimitation of the duties between market operators.


May 4, 2018 | Technical Documentation and Medical Device Regulation

A Guide for Manufacturers to Ensure Technical Documentation Complies with EU Medical Device Regulation 2017/745.