Following on from the Medical Device Regulation Survey carried out in 2019 , Innovate UK have commissioned ISO Lifesciences to carry out a follow on survey that seeks to understand the regulatory situation of UK diagnostics companies.
“Innovate UK have commissioned a survey to understand the how the EU IVD Regulation (IVDR) will impact on diagnostics companies.
This is an opportunity for you to provide feedback to Innovate UK to enable them to develop support mechanisms for the industry (if needed) associated with implementation of the IVDR.
The IVDR came into force on 25th May 2017 with a five year transition period meaning it will be fully implemented on 26th May 2022.
We want to try and ensure that we get the views of as many companies as possible and would greatly appreciate it if you could fill out this confidential ‘IVDR Readiness’ survey.
The deadline for completion of the survey is 6th Nov 2020. No company specific information will be divulged and the findings will be shared with the participants.
Survey link: https://www.surveymonkey.co.uk/r/2XPPR3D
Who should fill in the survey?
- Participants : Manufacturers (Commercially available products); Pre-Market Innovators
- Responses: 1 response per company
- Respondent: Individual responsible for coordinating IVDR compliance (e.g. CEO, regulatory affairs manager)
Time taken to complete
Innovate UK is part of UK Research and Innovation (UKRI), a non-departmental public body funded by a grant-in-aid from the UK government.
We drive productivity and economic growth by supporting businesses to develop and realise the potential of new ideas, including those from the UK’s world-class research base.
Specifically, we provide funding for health life science companies through our SMART, Biomedical Catalyst and Digital Health Technology Catalyst funding programmes. “