In this article, NDA’s Tina Amini explains what companies need to look out for in the growing area of device regulation.
Recent scientific advances and improvements in enabling technologies have opened new avenues for convergence among medicines, diagnostics, and devices. The medical technology industry continues to be one of the most diverse and innovative sectors.
Major shifts in the health care environment including regulatory requirements make it increasingly difficult for medical technology companies to sustain traditional growth and profitability.
WHY CAN WE SAY THAT THE REGULATORY CHALLENGES IN THE MEDICAL DEVICE FIELD ARE GROWING?
With the introduction of the new Medical Device Regulation (MDR), and the pending In Vitro Diagnostics Regulation (IVDR), the regulatory landscape in the EU has undergone tremendous change. The new situation gives rise to uncertainties and unknowns and it will take time before it settles and becomes predictable again.
WHY WAS THE NEW REGULATION INTRODUCED?
“The new regulation aims to boost patient safety and effectiveness of all the medical devices that are commercialised but also to increase transparency to make the process clearer to everyone involved.”
“Shortcomings in the Directive in divergent interpretations also resulted in different output from the Notified Bodies. The new regulation attempts to address this as well.”
HOW DOES THE NEW REGULATION CHANGE THE EUROPEAN DEVICE MARKET?
“The situation is currently uncertain. The delay in the database EUDAMED, an insufficient number of designated Notified Bodies, and lack of sufficient Guidance documents are all causing challenges. There is a lot of guess work awaiting official decisions and guidance. It is however certain that the new regulations will bring substantial change to how medical devices are brought to and maintained in the market.”
“The regulation also impacts the Notified Bodies as they have to be re-designated under new regulations. The time and cost associated with this has actually resulted in some Notified Bodies not applying for designation under the new regulations.”
“Up until now only eleven Notified Bodies have been designated under MDR, and three under IVDR and not all with full scope, compared to about 80 Notified Bodies that were operating under the MDD in the early 2010s. Today there are not enough Notified Bodies to pick up all the work. For companies this means longer timelines as you queue to have your product reviewed. We’re already seeing the manufacturers struggling to find a Notified Body to take them on.”
Article originally published in the April 2020 issue of Pharmafocus
HOW WE CAN HELP?
NDA’s Medical Device Division has extensive experience with both medicines and medical devices. We can support you with your interactions with Notified Body and assess your product from a scientific, technical, and regulatory perspective to be adequately prepared to meet the requirements. We also have the expertise to help manufacturers to implement the requirement of the MDR and IVDR regulations.
To learn more about how we can support your company, click here to see our full range of services.