Under the EU Medical Device Regulation (MDR), manufacturers are required to plan, conduct, and document a clinical evaluation in accordance with Article 61, part A of Annex XI. This evaluation must be based on clinical data providing sufficient clinical evidence to demonstrate: Despite being among the highest risk, certain implantable and Class III devices may...
As a sponsor wisely noted, “Clinical trials have nothing without participants.” Yet, in a 2023 study, 48% of sites cited patient recruitment and enrollment as a top challenge. The downstream impacts of recruitment challenges are profound for sponsors, sites, and most importantly, for patients in need of life-changing therapies. Ironically, on examination, the causes for...
Medical devices are ubiquitous — from thermometers, bandages, and dental floss to blood glucose meters, hearing aids, and complex implantable devices such as pacemakers. The latest cutting-edge examples even extend to apps on tablets and PCs that physicians use to help monitor and treat patients. Before a medical device can be put on the market,...
CE marking is mandatory for marketing medical devices and in vitro diagnostics (IVDs) in the European single market, comprising all European Union (EU) member states and European Economic Area (EEA) countries. With the introduction of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), there has been a significant overhaul of the...
CE marking is a cornerstone to the functioning of the European single market, which allows free movement of goods among not only the member states of the European Union (EU), but also the countries of the European Economic Area (EEA). For medical devices and in vitro diagnostics (IVDs), CE marking is mandatory for marketing, and...
On September 29, 2023, the U.S. Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. The FDA is proposing a change to its regulations to...
The EU has been working to strengthen its regulations for better patient protection and more effective implementation of the rules for in vitro diagnostic medical devices. As a result, in May 2017, a five-year in vitro diagnostic regulation (IVDR) transition plan went into effect. While some of the dates have been extended1 to allow for...
At its core, the success of any clinical trial rests on clean, conclusive data. This creates challenges. Throughout a trial, the data must be properly aggregated, scrubbed, analyzed, acted on—and all those steps must be recorded, to assure regulatory authorities of their accuracy. As the industry continues to evolve, new solutions to these challenges have...
The In Vitro Diagnostic Regulation (IVDR) has fundamentally changed how in vitro diagnostics (IVD) are regulated in the EU. As a result, scrutiny for review and documentation has increased substantially, including a dramatic increase in required reviews by notified bodies (NB). For IVD companies, the challenge of adapting to a significant set of regulatory updates...
The EU has been working to strengthen its regulations for better patient protection and more effective implementation of the rules for in vitro diagnostic medical devices. As a result, in May 2017, a five-year in vitro diagnostic regulation (IVDR) transition plan went into effect. While some of the dates have been extended1 to allow for...