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TECHNICAL LETTERS

July 31, 2020 | EC-REP: Responsibilities, mandate and joint liability

This article discusses the responsibilities of an EC-REP and further focusses on the setup of the mandate binding the manufacturer and the EC-REP. It will also elaborate on the EC-REP’s joint liability with the manufacturer for defective devices provided for by the MDR and IVDR.

July 21, 2020 | ISO 20417: Information to be supplied by legal manufacturer

Information supplied by the legal manufacturer is a key aspect to ensure the safe and effective usage of the medical device by its intended user and contributes for minimizing the possibility of user errors.

July 10, 2020 | PRRC function and liability

This article aims to discuss PRRC qualification requirements and PRRC function, as well as to clarify the legal liability of PRRCs.

July 6, 2020 | Article 16 and distributor / importer certification

The objective of this Tech Letter is to clarify this article 16 and notably what a distributor or importer is or is not allowed to do in terms of relabeling and repackaging, as well as when certification is required.

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.

WHITE PAPER

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.