Sep 1, 2021 | News, Regulatory
The European Commission announced that 70% of adults in the European Union (EU) are fully vaccinated against COVID-19, meeting the target that was initially set in January 2021, at the start of the vaccine rollout. This milestone marks a success for the EU’s...
Jul 14, 2021 | News, Regulatory
The Medical Device Coordination Group (MDCG), part of the European Commission, has provided a guidance document navigating the use of codes under the In Vitro Diagnostic Regulation (IVDR). The codes are used to describe the qualifications of both the notified body...
Apr 2, 2021 | News, Regulatory
The European Commission released a roadmap for its planned revision of pharmaceutical legislation for next year. With the adoption of the new strategy, which is “intended to make the European pharmaceutical system patient-centered, future-proof and...
Jan 13, 2021 | News, Regulatory
The European Commission (EC) announced this week that it will now be accepting remote audits during the pandemic for some European medical device and in vitro companies. The cleared pathway comes in time for upcoming deadlines in May 2021 and 2022 for the EU’s MDR...
Jul 17, 2020 | News, Regulatory
The European Commission (EC) has granted approval for Novartis’ Enzair Breezhaler, a medicine for uncontrolled asthma. The drug therapy is utilized as a maintenance treatment for adults with asthma. “Novartis is working to reimagine medicine for people with...
