Almost after a year-long delay EUDAMED is finally here and has launched its first of its six modules in December 2020. Recently, the EU Commission posted a guidance document explaining how to manage the registration of legacy devices in the...
Quality and performance standards are revised every three to five years, or sometimes sooner, depending on the industry need. European regulations accept European specific versions of ISO standards when assessing conformance of the product and the organization’s quality management system. The...
The Medical Device Single Audit Program covers the compliance requirements of the USA, Brazil, Japan, Canada, and Australia. Although this program does not cover the requirements of the EU, which is the EU MDR and IVDR, a guidance document released...
The EU MDR and the IVDR layout the performance and safety requirements for medical devices and In-vitro diagnostics respectively in the EU. According to Article 8 of the EU MDR and the IVDR, manufacturers that comply with the harmonized standards...
Hundreds of medical devices have been placed on the US market under an Emergency Use Authorization (EUA) to aid in the fight against COVID-19. Much like other medical devices that follow a more routine regulatory pathway, devices under an EUA...
The EU commission released a guidance document this week that explains the commission’s policies for transitioning of CE certificates for combination products and for devices manufactured using animal tissues under the medical device regulations. Under the Medical Device Directives and the...
In light of the COVID-19 pandemic, the EU commission adopted the Regulation (EU) 2020/561 that deferred the application of the EU Medical Device Regulations, which were set to go into effect in May 2020 by a year. This also means...
In our last blog on COVID-19’s impact on the EU MDR, the commission had not yet laid out any intentions of moving the EU MDR deadline, which was slated for next month. With close to 2 million confirmed cases globally,...
The European Medical Device Coordination Group published a joint implementation plan ahead of the May 2020 deadline for the full implementation of the EU MDR. The plan addresses the concern that the implementation of the MDR has proven to be...
With the number of confirmed COVID-19 cases now exceeding 200,000 globally, the WHO and many other international government agencies are either recommending or enforcing a “shelter in place” order to slow the spread of the disease.1 This is an unprecedented time...