Although preliminary MDR and IVDR requirements are well known by notified bodies for a long time, many challenges within these notified bodies can be identified. An important challenge is the internal capacity to serve their clients after the publication of the MDR and IVDR. A lack of clinical expertise and a proper understanding of the medical claim in the assessment teams of the notified bodies is still a recognized issue. Further, the administration of some significant registrars and or notified bodies is today still an Achilles. A new style of supervision by competent authorities and accreditation institutions will creating a new style of bureaucracy, will decrease the flexibility among notified bodies and or registrars further. These developments will influence expected service level by their clients: manufacturers of medical devices and critical (supply chain) partners.
The impact of the MDR demands more clinical data. This means more investments for SME companies. We’ve developed and invested in a special service program for small companies to organize and to perform clinical evaluations, to validate their devices on i.e. safety, performance, usability. We do have independent medical professionals, i.e. cardiologist, under contract to be able to support you in the communication between you and your notified body and or national competent authority.
The consequence of the MDR and IVDR implies more resources and investments by the economic operators. At this moment the real cost picture of the CE marking process after the adoption of the MDR or IVDR does know multiple factors. MRM is able to support you in this process to identify creative solutions.
The Brexit will bring a lot of uncertainties for many economic operators active in the medtech niche who’re depending on UK based notified bodies and Authorized Representative service providers. MRM does have the infrastructure to support these economic operators on such way to the continuity is guaranteed.