Outsourcing of MDR manufacturer status - handing over the "MDR rucksack"

In a recent article for DeviceMed, Dr. Oliver Stöckel sheds light on the obstacles that small and medium-sized enterprises (SMEs) face when it comes to MDR certification of their medical devices. The challenges associated with costs and regulatory hurdles are often overwhelming. But there is a promising way out: strategic outsourcing of production processes, including manufacturer status.

The requirements of the Medical Device Regulation (MDR) pose enormous challenges for companies, especially SMEs. The certification of medical devices in accordance with the MDR not only requires a considerable amount of time and money, but is also characterized by bottlenecks at notified bodies and service providers. In response, many companies are looking for alternatives in order to shed the "MDR rucksack" and consolidate their market position at the same time.

One promising solution is the strategic outsourcing of production processes, including legal manufacturer status. This measure not only allows companies to avoid regulatory hurdles, but also to benefit from efficiency gains and cost savings. But what aspects should be considered?

Read the complete article at devicemed.de (in German)