Introduction and Demographics

Key Insights

15% of organizations are fully prepared to hit the IVDR deadline on 26 May 2022.
55% want more guidance from European Commission and/or MDCG.
38% are planning to transfer all of their portfolio of products to IVDR.
21% currently have an IVDR certified product.
95% say the COVID-19 pandemic has impacted their IVDR implementation.

EU IVDR State of the Industry 2021

After a challenging four years of preparation for the EU IVDR, there is less than a year left on the clock. However, after facing the global COVID-19 pandemic in 2020, is industry ready to meet the IVDR requirements? Are there enough Notified Bodies with CE Marking and do they have the capacity and time to handle all IVDR certificates heading their way? Are PMS and Clinical teams ready to adapt to the longer-term commitments required? Are organizations confident in the resources they have to maintain compliance once their CE marks are approved?

MedTech Summit in association with NSF conducted a huge survey of medical device and IVD professionals across Europe and the world to discover the industry's answers to these questions. This final report based on 108 responses reveals unique insights into how prepared organizations are for IVDR implementation, the biggest challenges and how industry insiders are tackling them.

In this section we look at the demographics of the respondents. Use the Contents menu in the top left to jump to another section or download this report as a PDF.

Respondent organization: Almost half of respondents work for an IVD company

Size of organization: 40% of respondents work for large companies with more than 500 employees

Eljar Amini-Nejad, Client Solutions Senior Consultant EMEA at NSF introduces the report:

“The IVD industry recognises the huge hurdles of complying with the In Vitro Diagnostic Medical Device Regulation (IVDR) (EU) 2017/746 by May 26, 2022. Some IVD manufacturers have had a slow start to the transition to the EU IVDR with many manufacturers interacting with the regulation and Notified Bodies for the first time.

With the added pressure of the global COVID-19 pandemic, more stringent responsibility on manufacturers, as well as an increased demand on designated Notified Bodies, the industry will be asking themselves some tough questions about their readiness for the EU IVDR.

The findings in this survey provides us with some much-needed answers on state of the IVD industry in 2021, with less than a year until the Date of Application.

With no signs from the European Commission of delaying the deadline - as withthe EU MDR, the industry needs to move fast before patients suffer the consequences.

IVD manufacturers should get their space in the queue for Notified Body conformity assessments and complete their technical files with help from consultants if needed ASAP before it’s too late.”

NSF can accompany you on the journey and support you with training, consulting, preparation of technical files, technical file remediation, performance evaluation reports and strategic questions.

Find out more at www.nsf.org/IVDR