Ukraine RAA — Guiding You to CE Marking Success
At Ukraine RAA, we provide comprehensive consulting services to support manufacturers of medical devices and in vitro diagnostics (IVD) in achieving CE Marking under EU Regulation 2017/745 (MDR) and 2017/746 (IVDR).
Whether you are a start-up or an established manufacturer outside the EU, we help you navigate every stage of the regulatory process — from initial documentation assessment to final certification by a Notified Body.
Our Core Services
- Gap Analysis & Strategy Development
We perform a detailed Gap Analysis of your technical documentation, quality system, and labeling to identify missing elements required for MDR/IVDR compliance.
You receive a clear action plan with priorities, timelines, and cost estimation for CE certification.
- Technical Documentation (Annex II & III)
Preparation, structure, and review of:
- Device description & intended purpose
- Design and manufacturing information
- Risk management and usability engineering files
- Product verification & validation data
- Clinical evaluation (CER) / performance evaluation (PER)
- Post-Market Surveillance (PMS) & PMCF documentation
We ensure your files meet Notified Body expectations.
- Clinical & Performance Evaluation
Support in compiling or updating Clinical Evaluation Reports (CER) or Performance Evaluation Reports (PER).
Includes literature search strategy, data appraisal, equivalence assessment, and summary of safety & clinical performance (SSCP).
- Testing & Validation Support
Coordination of required laboratory testing (biocompatibility, sterilization, packaging validation, shelf life).
We work with EU-accredited labs and can help plan the test matrix to optimize time and cost.
- EU Authorised Representative (EC REP)
For non-EU manufacturers, we assist in appointing a trusted Authorised Representative and establishing formal agreements in line with MDR Article 11.
If needed, we can recommend reliable EU-based partners.
- Notified Body Liaison
We assist in the selection and communication with Notified Bodies, preparation for audits, and submission packages.
You receive direct guidance on QMS, device classification, and conformity assessment routes.
Additional Services
- Preparation for ISO 13485 certification
- Development of labelling and IFU compliant with MDR
- Registration in EUDAMED
- PMS, vigilance & trend reporting setup
- PRRC (Person Responsible for Regulatory Compliance) function (outsourced)
Why Choose Ukraine RAA
- Experience with Class IIb and III devices, including sterile and implantable products
- Practical insight into Notified Body expectations
- Flexible collaboration model — per project or full regulatory package
- Transparent pricing and personal communication
Get in Touch
Let’s discuss your project and determine the most efficient path to CE certification.
Contact us at s.kharchenko@yahoo.com or complete the online form.
We help you bring your medical device to the European market — safely, efficiently, and in full compliance.