Medical Device Regulation newly implemented

Medac GmbH is a German pharmaceutical company with over 1,200 employees that focuses on therapeutics for the diagnosis and treatment of oncological, urological and autoimmune diseases. The company is represented in 15 countries worldwide.

Compliance with and implementation of the requirements of the Medical Devices Ordinance

Medac GmbH was faced with the challenge of the new Medical Devices Regulation (MDR). What at first glance appeared to be a long period of implementation turned out to be an ambitious goal on closer inspection. The new regulation deeply intervened in the complex development processes and also applied to products that had already been launched on the market in accordance with earlier regulations. In addition to the time-consuming conversion processes, delays resulting from the necessary tests and approvals also had to be taken into account. The interaction with various country organizations brought additional complexity.

„This project showed how important good stakeholder management is in projects right from the start. Only the kickoff event with key representatives from the specialist departments showed the scope that was required by the change in the law in the organization and also created the necessary understanding for the urgency among parts of the management. The requirements analysis carried out revealed a mountain of measures, the feasibility of which was evaluated by the interdisciplinary team in terms of costs and benefits. The biggest challenge was not to lose parts of the team again due to the sheer number of requirements and their tasks in day-to-day business.“

Dr. S. Schubert - Project Management


Contribution HoPM:

During the initial discussion of the regulation, an initial, very rough analysis of the requirements was carried out. The subsequent kickoff meeting on the subject of EU MDR with all the departments involved met with a great response and created a common awareness of the scope within the departments and management. Under the direction of the project manager, the cross-functional team evaluated all requirements and derived appropriate measures for implementation. This also resulted in strategic questions regarding the product range and the organizational structure. For example, the project team considered whether the continuation of an affected product line was still economically viable. The constant restructuring of the company and the bridging to parallel running development projects posed an additional challenge.

Through targeted communication, all information relevant to the project could be provided and conflicts avoided at an early stage. In addition, the necessary tools for planning were compiled from the available system and supplemented by our own methods for stakeholder and requirements analysis.


Dr. Sophia Schubert

Project Management


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