EU IVDR Consulting and IVD Technical Documentation
We plan your in vitro diagnostic device pathway under EU IVDR 2017/746, from intended purpose and risk classification to performance evidence and submission preparation. Based in Izmir, MedENvolve provides documentation support in Turkish and English, taking account of your existing data, quality system and product development stage.
Scope of services
- Regulatory strategy: Clarification of intended purpose, target population, specimen type, user and use setting; assessment of Annex VIII classification and the conformity assessment pathway.
- Technical documentation: Organisation of device description, design and manufacturing information, GSPR mapping, risk management, label and IFU consistency, and verification and validation evidence within the Annex II and III structure.
- Performance evaluation: Preparation or review of the PEP and PER; critical assessment of scientific validity, analytical and clinical performance evidence; alignment of literature and the state of the art with device claims.
- Post-market activities: Development of PMS and PMPF plans, data sources, evaluation methods and a report update approach.
- Submission readiness: Where applicable, assessment of notified body scope, submission file review, and evidence-based support for assessment responses and CAPA.
Our IVD project experience
Our experience with NGS-based IVD kits includes IVDR technical documentation, GSPR, risk analysis, performance evaluation and validation protocols. We also have experience in quality systems and regulatory documentation for IVF, IUI and ICSI products and sperm-counting devices. The applicable MDR or IVDR framework is assessed separately for each product according to its intended purpose.
Information to share at the start
Share your product name, intended purpose, technology, specimen type, existing classification rationale, performance reports, current IFU and target markets. The initial review defines the scope and priority evidence gaps.
