Our view
Medical Devices are most important for our health care system. The idea of the new legislations was to improve the directive in all aspects especially in regard of safety. A target probably supported by everyone. But what happened?
Politics did politics only not evaluation reality before the laws were passed. Chaos is the result and industries have warned from the beginning and worked on solutions to support and help transforming the Directives into the new Regulations.
To date there is no strategy for the problems and the endangering of the functioning of the health care systems recognizable. None of the recommendations provided by MDCG is comprehensive nor they are in many cases clear and really a help. EU is endangering the strong position of EU’s MD industries.
Steinbeis MBT therefore tries to support all activities to review the existing CERs and PERs in regard of the existing GAPs and – even more important – how to close the GAPs. In addition we are offering accompanying training.
From Directives to one Regulation:
MDR 745/2017
Key of the technical documentation is the CER and the Clinical Evaluation (CE) and with the upstream literature review. The CE is key and the required data should be carefully analyzed to ensure their acceptance by the responsible Notified Body.
IVDR 746/2017
Key of the technical documentation is the PER and the Performance Evaluation (PE) combined with the upstream literature review. The PE is key and the required data should be carefully analyzed to ensure their acceptance by the responsible Notified Body.
Offer
Steinbeis MBT offers seminars based on your requirements and experiences to ensure that your staff is completely inline with the management’s expectations and at the same time we support your work with our expertise.