MedTech Europe is launching the 2022 IVD survey to assess the European IVD market, the transition to the IVD Regulation and infrastructure. BIVDA strongly encourages all IVD manufacturers, from small and medium to large IVD enterprises operating on the European market to participate in the survey.
Our aim is to provide our regulatory authorities with a realistic picture of the state of the IVD Regulation’s implementation so that they can take appropriate and informed measures when deciding upon if/what measures to give the IVD Regulation system. Your feedback is therefore of utmost importance.
Your data will be collected, anonymised and aggregated into a country-specific or European report. We will publish our findings and share the report with authorities and third parties as stated in the disclaimer of the survey.
How to participate? Go to link X [LINK AVAILABLE ON FRIDAY] and respond to as many questions as possible. To gain a whole picture, we are asking a long list of questions, please reserve sufficient time and patience to complete the questionnaire.
- Kindly provide only ONE answer per company. Check internally with your colleagues.
- Do NOT send us your answers via documents (WORD, PDF, etc.). We attach a PDF file of questions for information and in case you need to use it internally. The only way to participate in the survey is through the link, see above.
- Carefully read the introduction and each question.
- Complete the survey by latest Friday 21 October 2022.
- If you have enquiries or if you wish to receive a copy of the information you provided, please contact Iana Slobodeaniuc at regulatory@medtecheurope.org.
The similar survey run last year covered 90% of the European IVD market (results IVD survey 2022) and was successfully cited by European Commission when proposing the amendment to the IVDR transition periods (source). We hope to reach as many manufacturers in 2022 and we encourage you to respond with an accurate picture of your devices, applications and certifications.
