Medical device industry has been a booming industry with new technologies being introduced from time to time and has been dynamic in terms of Regulatory landscape. The year 2020 has seen a major disruption due to the COVID-19 Pandemic and demanded the Health Agencies to gear up for addressing the pressing situation, thus impacting the Agency’s plan of action.
In the face of COVID-19 emergency, the European Medicines Agency (EMA) established faster scientific advice, rolling reviews and accelerated assessments to expedite the development and approval of medicinal products. EMA’s foresight is to support the development and marketing authorization of safe, effective and high-quality therapeutics and vaccines at the earliest. As claimed, EMA adapts rapid procedures to significantly cut-short the Regulatory timelines for the review of new medicines and vaccines against COVID-19.
The regulations of the medical device industry in Europe may have remained relatively unchanged since the 1990s but recent upheavals such as the breast implant crisis and hip replacements resulted in immediate Regulatory reforms. With the EU’s new Medical Devices Regulations (MDR) formally published in May 2017, medical device companies now have three years to comply with the upcoming changes before the new rules put into force from 2020.
With over 5,00,000 types of Medical Devices (MDs) and in-vitro diagnostics (IVDs) existing, the European MD and IVD market stands as a major economic player. On the other side, recent scandals pertaining to certain classes of medical devices exposed the frailties of medical device regulations in the region. With the growing concerns about the weaknesses in the current system, the European Union (EU) was in plans to implement tougher rules governing the safety and monitoring of medical devices.
