Jan van Lochem, CEO: "With the Christmas holidays quickly approaching, we are reflecting on 2018, a year in which many companies began to implement the EU MDR.
We are currently halfway through the transition period for the MDR. While some companies have begun the implementation, others are at the early stages of analyzing the impact of the new regulations on their product portfolio. Although the MDR is a European regulation, it is evident that it will also greatly impact the registration of devices outside the EU.
Notified Bodies are also preparing for their MDR designation. While Notified Bodies are not yet assigned, the first designations are expected early in the new year.
The most significant impact on device manufacturers will be the need for more clinical data during the entire life cycle of the product and emphasizing the role PMCF plays in this aspect. PMCF may prove an efficient tool when used with a practical approach to gather additional clinical data. Combining this process with the appropriate regulatory strategy and gathering sufficient technical data to build equivalence cases, will be a critical factor for successful results. Qserve has developed an integrated approach to implement the consequences of the new requirements, which will define the industry standard for years to come.
On behalf of the Qserve Group team,
we would like to wish you a Merry Christmas and a Healthy 2019!
We look forward to collaborating with you and your team for a successful 2019!
The board of directors: