SGS proderm workshop paves the way to recertification
On 26 May 2021, the Medical Device Regulation (EU) 2017/745 came into force simultaneously in all EU member states. This has resulted in significant changes with regard to the market authorization of medical devices. However, medical devices already on the market are also affected, as the MDR only grants a transition period until May 2024 (Art. 120).
Due to the heavy demands on the Notified Bodies and the corresponding waiting periods, as well as the times for the necessary regulatory approval procedures, it seems sensible to tackle the re-certification or new certification immediately and to carry out the necessary studies to prove performance and compatibility. At the same time, we see a high need for advice on the part of manufacturers, especially in the dressings market, with regard to the re-certification or new certification of their products and a certain uncertainty with regard to the measures to be taken: The necessary scope of conformity assessment, the question of the applicable directives, the uncertainty regarding the Notified Bodies and their capacity - all these are aspects that have to be clarified on the way to recertification. The situation is further complicated by the fact that there are many different testing options for dressing materials, which means that special care must be taken in determining the optimal study design.
Workshop 'Recertification of wound dressings'
Prompt action is required if manufacturers wish to continue their marketing authorization after the deadline. In order to support you quickly and in the best possible way on your way to recertification, we have created the 'Recertification of wound dressings' workshop. This format is designed to clarify your individual issues and develop a strategy to achieve recertification on time.
The workshop contents at a glance
The following points represent only a selection of possible topics that we will work on with you during the workshop. The content and scope of our workshops are always tailored to the individual needs of our clients - following a free initial consultation.
- Data evaluation
- Risk class
- Conformity assessment
- Regulatory infrastructure and notified bodies
- Trial strategy
- Milestones and timetable