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Regulatory


Previous page: The new MDR regulation, introduced in 2017, exists to improve regulatory processes and ensure the safety of products from manufacturers to end-users.


immediately after its entry into force in May 2017. However, the implementation of the new infrastructure that undergirds MDR (the new EUDAMED database, and the new registration and reporting procedures, for example) is ongoing, limiting what individual companies can do. In addition, designation of the notified bodies under the new regulation has taken some time, and many more may yet be required.


The MDR application, auditing and designation process takes a great deal of effort from notified bodies, which translates into various unexpected costs and price increases. Moreover, to meet the new regulations, notified bodies are required to


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restructure their organisation and increase resources to provide relevant services, further increasing production costs, and necessitating the hiring and training of new staff, all of which takes time. Overall, MDR demands higher regulatory oversight, which means additional and regular assessment, resulting in higher total certification costs within a period of five years. Specifically, there are more rigorous clinical testing requirements to support clinical evidence for Class III and implantable medical devices. Manufacturers will need to conduct extra clinical investigations if they do not have sufficient clinical data to demonstrate both safety and performance of a dedicated device according to MDR’s exacting standards. For Class IIa and Class IIb medical devices, meanwhile, manufacturers will need to re-prepare their clinical evaluation by considering the new wording of the regulation on when an equivalence approach can be taken and under which circumstances it is possible to justify not conducting a clinical investigation. There is also a stronger emphasis on post-market surveillance, requiring more rigorous oversight from notified bodies to reduce risks from unsafe devices.


For all of that, the companies that began thinking about MDR early are those who have found the transition smoothest. They have been able to accommodate hold-ups, train personnel, consult with experts and, when in doubt as to how to meet a particular requirement, get clarification from notified bodies and competent authorities. In fact, the EU’s regulators have been supportive and mindful in handling the transition. For them, working closely with the industry is key to making MDR functional. By doing so, they can better ensure the safety and efficacy of approved products. They have also paid close attention to economic impacts and the Covid-19 pandemic, altering regulatory requirements for key products and devices as necessary. That said, areas for improvement include the preparation and publication of guidance documents, as well as the readiness of infrastructure such as EUDAMED to support the regulation.


22 Medical Device Developments / www.nsmedicaldevices.com


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