The European Association of Medical devices Notified Bodies (Team-NB) and its members fully support the objectives of the MD and IVD Regulations (MDR and IVDR) which aim to “establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation”.
Team-NB welcomes today’s surveys and publications on the implementation of the Medical Devices regulations to improve the regulatory context to reach a better healthcare system ensuring a high level of patients’ safety as well as confidence and promotion of innovation in the medical device industry when backed by solid safety and effectiveness data.
At the October general assembly meeting, the members aligned on a strategy including both high level objectives for the future of the sector with the aim to meet the highest level of public health and also operational aspects to respond to the concerns regarding the difficulties encountered with the implementation of the MD and IVD Regulations (MDR and IVDR).
Team-NB High level position on the regulatory framework for the medical devices sector