EU MDR Consulting: Achieving Seamless Compliance for the European Market
Master the complexities of Medical Device Regulation (EU) 2017/745. From Biological Evaluation Plans (BEP) to successful Notified Body audits, EBI is your strategic partner in CE marking.
Navigating the MDR Challenge
The transition to MDR (EU) 2017/745 has significantly raised the bar for clinical and biological evidence. For many manufacturers, the increased requirements for technical documentation and post-market surveillance are a major bottleneck.
At EBI, we specialize in bridging the gap between raw laboratory data and the rigorous expectations of Notified Bodies. We don’t just provide a report; we provide a comprehensive Biological Evaluation narrative that demonstrates your device’s safety and compliance.
Our EU MDR Consulting Services
Under MDR, a simple test report is no longer enough. You need a continuous evaluation process.
- Biological Evaluation Plan (BEP): We develop a proactive strategy (ISO 10993-1) to identify necessary testing, leveraging existing data to reduce time and costs.
- Biological Evaluation Report (BER): Our experts synthesize all testing data, clinical evidence, and literature into a high-quality report ready for Notified Body review.
- Expert Opinions: Professional toxicological and biological assessments that stand up to the toughest regulatory scrutiny.
Are your legacy devices truly compliant with the new MDR standards?
- We perform a detailed audit of your existing technical files.
- Identification of „gaps” in biocompatibility data.
- Strategic roadmap to achieve compliance with minimal disruption to your supply chain.
3. Chemical Characterization & Toxicology (ISO 10993-18)
MDR places a heavy emphasis on material characterization to minimize animal testing.
- Analytical Chemistry (E&L): In-house state-of-the-art labs for extractables and leachables studies.
- Toxicological Risk Assessment (TRA): Expert evaluation of chemical risks by certified toxicologists to satisfy Annex I General Safety and Performance Requirements (GSPR).
4. Post-Submission Support (Notified Body Interaction)
Our job isn’t done when we deliver the report.
- Audit Support: We provide free consulting and technical support if your Notified Body has questions or requires additional justification.
- Zero-Rejection Goal: Our approach is designed to meet the specific expectations of major Notified Bodies (TÜV SÜD, BSI, DEKRA, etc.).
The EBI Advantage for European Manufacturers
- 100% In-House Labs: Unlike many consulting firms that outsource testing, we perform all in-vivo and in-vitro studies in our own labs. This ensures total data consistency and faster timelines.
- Regulatory Experts: Our team speaks the language of Quality Assurance (QA) and Regulatory Affairs (RA) specialists.
- 99% On-Time Delivery: We understand that every day your product is not on the market is a lost opportunity. We eliminate the backlogs common in larger European laboratories.
- Local Support, Global Standards: Based in Europe, we offer fast responses (within 48 hours) and easy communication via video calls.
How We Work
Discovery & Insight
We begin with an in-depth consultation to understand your needs, challenges, and objectives. This helps us define the right strategy and scientific approach for your project.
Design & Development
Our experts translate your vision into actionable plans — combining innovative research, data, and technology to build precise and reliable solutions.
Delivery & Support
We implement the solution with full transparency and ongoing communication. After delivery, we stay involved — supporting you with optimization, updates, and future improvements.
Frequently Asked Questions (EU MDR)
Do I need to redo all biocompatibility tests for MDR if I already have MDD certification?
Not necessarily. Through a professional Gap Analysis, we can determine if your existing data (ISO 10993) is sufficient or if supplemental testing/rationales are required to meet current MDR standards.
What is the role of ISO 10993-1 in MDR compliance?
ISO 10993-1 is the harmonized standard for biological evaluation. MDR requires a systematic „Plan-Test-Evaluate” approach, making the BEP and BER documents mandatory parts of your Technical Documentation.
How does EBI support interactions with Notified Bodies?
If a reviewer from a Notified Body asks for clarification on our biological evaluation, our experts participate in calls and provide written justifications at no extra cost to ensure your submission moves forward.
Do I need to redo all biocompatibility tests for MDR if I already have MDD certification?
Not necessarily. Through a professional Gap Analysis, we can determine if your existing data (ISO 10993) is sufficient or if supplemental testing/rationales are required to meet current MDR standards.
What is the role of ISO 10993-1 in MDR compliance?
ISO 10993-1 is the harmonized standard for biological evaluation. MDR requires a systematic „Plan-Test-Evaluate” approach, making the BEP and BER documents mandatory parts of your Technical Documentation.
How does EBI support interactions with Notified Bodies?
If a reviewer from a Notified Body asks for clarification on our biological evaluation, our experts participate in calls and provide written justifications at no extra cost to ensure your submission moves forward.
Contact with us
We’re open to collaboration and research partnerships. Fill out the form — our team will respond as soon as possible.
Location:
Europejski Instytut Biomedyczny sp. z o.o.
ul. Bartycka 63A lok. 6, 00-716 Warszawa
Mail:
contact@ebi.bio
Phone:
+48 22 780 06 32
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