CBAM Data Readiness
Turn scattered plant data into an emissions file your EU importer can use, and know whether actual values are worth the effort.
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EU market access for exporters
Decide which devices to certify in time, which to redesign and which to withdraw before legacy certificates run out.
Why now
Legacy medical devices can stay on the EU market under Regulation (EU) 2023/607 only until 31 December 2027 or 31 December 2028, and only if strict 2024 conditions were met. Four EUDAMED modules have been mandatory since 28 May 2026.
Owners, regulatory, clinical and commercial managers at Turkish medical device manufacturers selling into the EU.
A portfolio triage of the devices you sell into the EU.
We are not a notified body and do not prepare clinical evaluations. Conformity assessment comes from notified bodies, and regulatory submissions from qualified specialists.
Whitepaper
Short notes when a date or rule like this one changes.
A useful first conversation
Tell us the question, the buyer or rule behind it, and what you already have. We’ll come back by email with whether and how we can help.