Your MDR certificate depends on clinical data you may not have yet.
We run PMCF studies and registries at Turkish sites, so the data is ready before your notified body review starts.
The problem
Legacy device transition ends on 31 December 2027 for Class III and implantable Class IIb devices, and on 31 December 2028 for the rest. 1
Notified body reviews take 13–18 months, so the evidence must exist well before the deadline. 2
Many PMCF plans rely on a single-country registry that enrols too slowly.
Why Turkey
Volume.
High surgical and interventional volumes in a small number of large city hospitals.
What we do
- PMCF study design: endpoints, sample size, gap analysis against your CER
- Study set-up, TİTCK and ethics submissions
- Registries and retrospective chart reviews for real-world performance
- EDC, monitoring, biostatistics and the clinical study report
- Inputs ready for your PMCF evaluation report and SSCP update
How it works
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2 weeks
Gap check
We review your PMCF plan and CER and propose a study or registry.
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Start-up
Submissions, sites, contracts.
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Enrolment and follow-up
Per protocol, with interim data for your notified body.
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Report
CSR and data tables in the format your notified body expects.
Proof
- Founded 1997
- 1,226 projects delivered
- ICH-GCP
- ISO 9001
- ISO/IEC 27001
Send us your PMCF plan. We will tell you what is missing and how long it takes to fill.
Reply within one business day.
Book your PMCF planning call
Sources
- 1. Regulation (EU) 2023/607 of 15 March 2023 (legacy device transition deadlines). https://eur-lex.europa.eu/eli/reg/2023/607/oj
- 2. QbD Group, "EU MDR bottleneck ahead: why 2026 will be a critical year", 2025 — notified body certification reviews average 13–18 months. https://qbdgroup.com/en/blog/eu-mdr-bottleneck-2026-medical-device-manufacturers