Our regulatory subject matter experts are always helping a range of stakeholders solve compelling regulatory challenges associated with supply chain d...
Understanding Section 10.4.1 of the EU MDR
After a three-year transition period, the European Union (EU) Medical Device Regulation (MDR) 2017/745 is set to take full effect on May 26, 2020, rep...
Final SCHEER Committee Phthalate Benefit-Risk Assessment Guidelines Published
After a lengthy public consultation period, the European Commission’s long-awaited Scientific Committee on Health, Environmental and Emerging Risks (S...
Ask the Experts: August 16 Edition
Our regulatory subject matter experts are always helping a range of stakeholders solve compelling regulatory challenges associated with supply chain d...
Ask the Experts: August 2 Edition
Our regulatory subject matter experts are always helping a range of stakeholders solve compelling regulatory challenges associated with supply chain d...
EU MDR Replaces Medical Devices Directive, Prompting More Stringent Requirements for Medical Device Companies
The European Union (EU) Medical Device Regulation (MDR) EU 2017/745 replaced the Medical Devices Directive (MDD) on May 25, 2017, with the aim of impr...
New EU MDR Reporting Requirements Coming in 2020
Keeping up with the evolving compliance landscape can be challenging. From a growing list of labeling requirements to additional reporting criteria, c...
Notified Bodies Under the EU Medical Device Regulation: Avoiding Certification Delays
Thousands of medical device companies have until May 2020 to certify their products under the new European Union (EU) Medical Device Regulation (MDR 2...
Ask the Experts: March 29 Edition
Our regulatory subject matter experts are always helping a range of stakeholders solve compelling regulatory challenges associated with supply chain d...
Recertifying a Product Under the European Union Medical Device Regulation
In September 2012, the European Union Medical Device Regulation (EU MDR) 2017/745 was first proposed to address weaknesses in the existing Medical Dev...