May 26, 2021: This date will be remembered fondly by some medical technology manufacturers and less fondly by others. The new European Medical Device Regulation (MDR) has been in force since this date, having been adopted by the European Parliament and the Council in May 2017. The MDR replaces the previously applicable Medical Device Directive (MDD) and regulates the necessary steps that a manufacturer must follow before a medical device can be placed on the market, as well as the obligations after it has been placed on the market.
6 good reasons for outsourcing in times of MDR
MDR as a major challenge for medical technology manufacturers
The introduction of the MDR is a major and immediate challenge for most medical technology manufacturers. As if the implementation of the stricter regulations were not difficult enough, they come at a time when manufacturers are struggling to defend their competitive edge in a highly competitive market and are being forced into ever shorter innovation cycles. At the same time, margins are under pressure as customers and buying groups squeeze prices and additional requirements such as the MDR drive up costs. The question therefore inevitably arises
question of how long-term business success and profitability can be ensured under these circumstances.
In our white paper you will find more information on the exact changes brought about by the MDR, as well as compelling reasons for outsourcing that may not be immediately obvious.