EU

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...

Design of Experiments, or DOE as it is commonly known in the industry, is defined as a “branch of applied statistics that deals with planning, conducting, analyzing, and interpreting controlled tests to evaluate the factors that control the value of...

The Brexit has not only impacted Britain and the EU, it has made changes to the Northern Ireland region as well. As the UK will start implementing the UKCA mark, the Northern Ireland region will start using the UKNI mark...

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 COVID-19 pandemic halting life as many know it globally, the May 26th EU MDR deadline still looms over the medical device industry. Many industry groups and notified bodies have called upon the Commission to postpone the deadline until...