News and Resources
MDR Transition: What does it mean for your company?
Talk about the fundamental changes coming to European medical device regulation has been buzzing through the industry for the past several years. Medical device firms across the globe have been preparing themselves for changes to their regulatory compliance strategies...
Eudamed Update: Implementation is Paused, MDR Compliance is Not
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. ...
How the Pandemic Affects MDSAP Audits
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 Vitro Diagnostic Regulation Update
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...
Risk Management Series – Article 7 Part A: Determining Risk Acceptability
In our last two articles, Part 5: Assigning Harms and Severity and Part 6: Estimating Probability of Occurrence, we discussed approaches to develop values for these two elements of risk and the challenge of completing these...
Telemedicine: How the pandemic has changed healthcare services
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...
Notified Body Audits during the Pandemic: New MDCG Guidance
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...
Securing Updated and Necessary Statutory Evaluations Timely Rule
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...
Regulatory Relief to Support Economic Recovery
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...
RAPS Euro Convergence 2020 Summary
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...
