Check your EU Readiness in 2 Minutes 🚀
Planning to bring your medical device or in vitro diagnostic to Europe?
Answer a few short questions and receive a high-level, indicative overview of your current regulatory readiness and an experience-based estimate of potential CE‑marking timelines.
Important: This tool provides a non-binding, informational assessment only and does not constitute a conformity assessment under Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR).
Why Use Our EU Readiness Assessment?
Gain an initial understanding of your preparedness for European market access and identify areas that may require further development before engaging in a formal conformity assessment.
Indicative Timeline Overview
Receive non-binding, experience-based timeline ranges reflecting typical industry scenarios. These timelines may vary depending on device classification, documentation quality, clinical/performance evidence, and Notified Body availability.
Identification of Potential Gaps
Highlight possible gaps in key regulatory elements such as:
- Quality Management System (QMS)
- Technical Documentation (Annex II & III)
- Clinical Evaluation (MDR) or Performance Evaluation (IVDR)
Regulatory Support
Option to discuss your results with regulatory professionals experienced in MDR and IVDR requirements.
Indicative CE‑Marking Timelines
The following ranges reflect typical industry observations and are provided for general orientation only. Actual timelines vary significantly depending on individual circumstances and regulatory pathways.
~12–18 months (indicative)
- • QMS aligned with MDR/IVDR requirements (e.g. ISO 13485)
- • Technical documentation largely complete
- • Clinical (MDR) or performance (IVDR) data largely available
~18–24 months (indicative)
- • QMS implemented or nearing completion
- • Technical documentation in development
- • Clinical investigation or performance study planned
~24–36+ months (indicative)
- • QMS not yet established
- • Technical documentation not yet developed
- • Clinical (MDR) or performance (IVDR) studies likely required
Ready to Explore Your EU Readiness?
Complete our 2-minute short assessment to receive your personalized, indicative overview and better understand the steps involved in preparing for MDR or IVDR conformity assessment.