Report: EU IVDR State of the Industry 2021
May 23, 2022
MedTech Summit and NSF conducted a huge survey of medical device and IVD professionals to discover the industry’s readiness for the IVDR.
In June 2021, NSF partnered with Informa to launch a huge industry survey on how prepared organizations were just under a year until the IVDR date of application.
The survey asked questions around the impacts of the global COVID-19 pandemic, the industry’s readiness to meet the IVDR requirements, whether notified bodies have the capacity and time to handle all conformity assessments heading their way, changes to PMS and clinical requirements, and confidence in the resources manufacturers have to maintain compliance once their CE marks are approved.
Key insights from the survey:
- Only 15% of organizations are fully prepared to hit the IVDR deadline of May 26, 2022
- 55% want more guidance from the European Commission and/or the MDCG
- 38% are planning to transfer their IVD product portfolio to IVDR
- 21% currently have an IVDR-certified product
- 95% say the COVID-19 pandemic has impacted their IVDR implementation
How NSF Can Help You
Get in touch to find out how we can help you and your business thrive.
What’s New with NSF
Brooklands New Media’s Publication On NSF’s Global Animal Wellness Standards (GAWS) Not Endorsed by NSF
November 25, 2024NSF is aware that a firm called Brooklands New Media plans to publish a book to mark the 5th anniversary of NSF Global Animal Wellness Standards (GAWS).
Read the Story
NSF Opens Advanced Water Testing Laboratory in Germany
October 17, 2024European manufacturers gain a competitive edge with local NSF/ANSI/CAN 60 and 61 certification testing.
Read the Story
World Food Day: A Global Call to Action for Food Security and Sustainability
October 16, 2024NSF marks World Food Day – a global call to action to raise awareness about the pressing issues of hunger, food security and the importance of sustainable food systems. Established by the Food and Agriculture Organisation (FAO) of the United Nations, this day reminds us of the need to ensure that everyone, everywhere, has access to enough nutritious food.
Read the Story
NSF Welcomes Mel Cash as Chief Commercial Officer
October 14, 2024Global public health and safety organisation announces new Commercial lead to drive growth and innovation.
Read the Story