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Article 11
MDR 2017/745 · IVDR 2017/746
EU + TR
Two markets, one mandate
In-house
PRRC under Article 15
TR-MF-000057496
Registered in EUDAMED
TR-AR-000057550
Authorised representative SRN
Request a proposal
Under the EU–Türkiye Customs Union and Association Council Decision No 1/2006, medical devices and in vitro diagnostics lawfully placed on the Turkish market circulate freely within the EU. In its April 2022 notice to stakeholders, the European Commission confirmed that economic operators established in Türkiye may act as authorised representatives under the EU medical device framework.
For you, this means one mandate, one contract and one point of contact for both markets — instead of appointing a separate representative in Türkiye alongside your EU one.
Our process
How it works
01
Inquiry
02
Review
03
Mandate
04
Registration
05
Ongoing representation
Regulatory responsibility
Article 15(6) requires an authorised representative to have permanent and continuous access to a person responsible for regulatory compliance. Ours is in-house, not outsourced. Both partners are physics graduates of Middle East Technical University working in medical device manufacturing and regulatory affairs.
Request a proposal
To prepare a quote we need device names, intended purpose, risk class if known, and current certification status.