EU MDR advice

The EU MDR Medical Device Regulation was published in 2017 as a comprehensive revision of previous directives and has been in force since May 25, 2017. It thus replaces the Medical Devices Directive 93/42/EEC and the Directive on Active Implantable Medical Devices 90/385/EEC. Basic requirements, classification and conformity assessment procedures of in vitro diagnostics are regulated in the IVD guideline 2017-746 from April 2017. Here, too, harmonized standards are used to demonstrate compliance with the basic requirements. From May 26, 2021, when the extended transition period ends, the requirements of the EU MDR must be met by medical device companies. EU MDR compliance is required. With the Medical Device Regulation, the aim of the EU was to have a robust, reliable, transparent and sustainable regulatory framework available for all medical device manufacturers, which serves product safety and patient safety and at the same time promotes innovations. Orienting yourself here, implementing the relevant innovations in a targeted manner or implementing them for the first time sometimes poses a major challenge for players in the medical devices industry.

Compliance mit der EU Medical Device Regulation

While certification under the old and new law was still valid during the transition period, manufacturers of medical devices - with just a few exceptions and additional transitional provisions - now have to present an EU certificate in accordance with the EU MDR before they can be placed on the market.

It is known from practice that not all players in the supply chain are yet familiar with the new requirements. Furthermore, with a view to implementation, there are still urgent questions that still need to be answered by the EU Commission. How should the affected companies proceed here? The new EU MDR brings far-reaching changes - the widest possible and comprehensive preparation is required to ensure that the requirements for EU MDR compliance are met. This applies to all economic actors involved throughout the entire life cycle of the medical device: manufacturers, authorized representatives / representatives, importers, distributors, providers of systems / procedure packs in accordance with Article 22 (1, 3).

It is important to specifically identify and allocate the applicable innovations and to integrate them leanly and efficiently into the existing QM system.

medcycle comprehensively supports companies in the medical device industry and their suppliers so that they can continue to place effective and safe medical devices on the market in accordance with the requirements and mdr-compliant. Here customers can use the reliable knowledge of regulations and a structured approach in the projects and open up advantages.