European UnionTürkiye
MDR Transition Support
Best for: Manufacturers selling in the EU who need to complete MDR certification.
You receive
- Transition plan
- GSPR checklist
- Technical file structure
- Pre-submission review
European Union (MDR)
MDR deadlines are fixed. Notified body time is not.
Extended MDR transition periods end on December 31, 2027 and December 31, 2028. Technical documentation, ISO 14971 risk management, internal audits and notified body preparation.
Regulatory framework
The EU Medical Device Regulation (EU) 2017/745 has applied since May 26, 2021. Devices still on the market under MDD certificates rely on the extended transition introduced by Regulation (EU) 2023/607, which ends on December 31, 2027 for Class III and Class IIb implantable devices and on December 31, 2028 for other devices, provided its conditions are met. Notified body review takes time, so the realistic deadline for a complete file is much earlier than the legal one.
Dates and requirements are summarized from the official sources linked on this page. Always check the current official text.
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DetailsPackages for this market
See all packages All markets
Remote Internal Audit
Best for: Manufacturers under ISO 13485, FDA QMSR or EU MDR who need an independent auditor.
You receive
- FDA-presentable audit report
- Nonconformity log
- CAPA recommendations
All markets
Annual Audit Program
Best for: Manufacturers who want continuous compliance without a full-time auditor.
You receive
- Audit program
- Audit reports
- Quarterly status summary for management review
FAQ
We are outside the EU. What else do we need?
Non-EU manufacturers need an EU Authorized Representative. We do not provide that service, but we coordinate with the representative you choose.
Can you help us choose a notified body?
We can explain the selection criteria (designation scope covering your device codes, capacity, lead times, communication) and review your file before submission. The choice and contract are yours.
Do you cover risk management and biocompatibility?
Yes. ISO 14971 risk management files and ISO 10993-1 biological evaluation planning are part of our MDR technical documentation work. Testing itself is done by accredited laboratories.
Let’s map your route to market in 30 minutes
Tell us about your device, target markets and timeline. You’ll leave the call knowing which requirements apply, where your gaps likely are and what to do first.