EU MDR & CE Marking
The EU Medical Device Regulation (EU) 2017/745 raised expectations for technical documentation, clinical evidence and post-market surveillance. With extended MDD transition periods ending on December 31, 2027 and December 31, 2028, and notified body capacity still tight, preparation time is the scarce resource. We get your file ready for the questions your notified body will ask.
Transition planning
Checking the conditions of Regulation (EU) 2023/607 for your certificates and building a realistic plan to the deadline.
Technical documentation
Structuring the file per MDR Annexes II and III, with a GSPR checklist mapping each requirement to standards and evidence.
Risk management (ISO 14971)
Risk management plan, hazard analysis, risk control, benefit-risk analysis and risk management report, maintained through the lifecycle.
Biological evaluation planning
ISO 10993-1 biological evaluation planning and chemical characterization strategy, coordinated with your test laboratory.
PMS and PMCF
Post-market surveillance plan, PMCF literature review and the link back to risk management.
Notified body preparation
Pre-submission file review, application package and support with deficiency responses.
We do not act as EU Authorized Representative. Non-EU manufacturers need one; we can coordinate with your chosen representative.
FAQ
Is our MDD certificate still valid?
Regulation (EU) 2023/607 extended the validity of MDD certificates that meet its conditions to December 31, 2027 for Class III and Class IIb implantable devices, and to December 31, 2028 for other devices. The conditions include an MDR-compliant QMS and a timely application and written agreement with a notified body.
Can we classify our device ourselves?
Classification is the manufacturer’s responsibility, but the rationale must be documented and accepted by the notified body. Our free MDR classification tool gives a first assessment.
Other services
Remote Internal Audits
Independent ISO 13485, QMSR and MDR internal audits with reports written to withstand an FDA or notified body read.
QMSR Gap Analysis
Check your ISO 13485 system against the FDA QMSR and related US requirements, with a prioritized action plan.
ISO 13485 Quality Management System
One QMS built to serve EU MDR, FDA QMSR, Türkiye and Gulf requirements: set-up, upgrade and training.
Supplier Audits in Türkiye & Europe
On-site supplier audits for US and EU manufacturers sourcing components or services from Türkiye and Europe.
Validation
Sterilization validation, test method validation, cleanroom and process validation reviews.
CAPA & Quality Processes
CAPA, nonconformance, complaints, document control, batch record review and product release.
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.