Growing numbers of medical devices are using artificial intelligence and its associated technology—machine learning—to diagnose patients more precisely and treat them more effectively. Although many devices have already been cleared by the FDA, many regulatory...
On May 26 the new Medical Device Regulation (MDR) will replace the previous Medical Device Directive (MDD).
The new European medical device database, known as Eudamed, was originally scheduled to launch in May 2020, but the pandemic caused its implementation to be delayed two years, until May 26, 2022. However, that does not mean that compliance considerations are on hold. ...
The Medical Device Single Audit Program (MDSAP) has been a blessing for many medical device manufacturers because it has allowed third-party auditors to conduct a single audit of a medical device company to satisfy the regulatory requirements of the five countries...
In less than 430 days, the In Vitro Diagnostic Regulation will fully replace the EU’s current Directive on in vitro diagnostic medical devices (IVDD 98/79/EC). Are you prepared for the transition? What is In Vitro Diagnostic Regulation (IVDR)? The IVDR is the new...
While telehealth technology and its use are not new, trends show some increased interest in the use of telehealth services by both healthcare professionals (HCP) and patients. Due to the COVID-19 pandemic, changes in the way that healthcare is delivered are being...
It should come as no surprise that the far-reaching effects of the COVID-19 pandemic include how notified bodies are conducting audits of medical device manufacturers. The European Commission’s Medical Device Coordination Group (MDCG) recently released a document...
In the Trump Administration’s final days, the Department of Health and Human Services (HHS) has changed the US Food and Drug Administration’s (FDA) regulatory oversight policies. The Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule would force...
On May 19, 2020, President Trump issued Executive Order No. 13924. This order instructed HHS and FDA to “review any regulatory standards that they have temporarily rescinded, suspended, modified, or waived during the public health emergency,” in order to “determine...
The 2020 conference, or “convergence,” of European regulatory professionals that was originally to be held in October in Brussels instead took place virtually due to the pandemic. Even though it was conducted entirely online, the convergence covered a lot of...