Pre-Submission Support: How a Testing Lab Can Help You Prepare for Regulatory Feedback

Pre-submission is a critical phase in medical device development, especially under EU MDR. It’s the point where all your documentation — risk assessments, justifications, test reports — must stand up to Notified Body scrutiny. Many manufacturers underestimate the complexity of this stage. Partnering with a testing lab that goes beyond benchwork and into strategic regulatory support can make a significant difference. This is equally true for FDA submissions, where early engagement can streamline the review process and reduce deficiencies.

1. Where Manufacturers Struggle Before Submission

Preparing for regulatory submission involves a high degree of precision. Common pitfalls include:

• Unclear or unjustified test plans: Regulators expect to see a rationale for every test selected or omitted. Vague or poorly structured Biological Evaluation Plans (BEPs) can lead to delays.
• Data gaps: Incomplete chemical characterization, missing toxicological data, or absent justifications are among the top reasons for rejection.
• Inconsistent documentation: Discrepancies in exposure assumptions, mismatched test conditions, and lack of traceability can trigger major concerns.
• Insufficient alignment with ISO 10993-1 and MDR Annex I: A weak understanding of how biological risks relate to essential safety requirements can lead to deficiencies — a concern equally relevant to FDA’s expectations for biocompatibility.

2. How Testing Labs Provide Strategic Support

Top-tier labs offer more than just test execution. Their support extends into regulatory and scientific consulting:

• Preparation of Biological Evaluation Plans (BEPs) and Reports (BERs): Labs can ensure your documents are well-structured, evidence-based, and aligned with current expectations. They help eliminate inconsistencies and strengthen justifications. According to ISO 10993-1 BEP must be prepared by knowledgeable and experienced professionals – testing labs have them in place. 
• Toxicological gap analysis: Identification of missing data, evaluation of material disclosures, and comparison against toxicological databases are essential steps in preparing a robust Biological Evaluation Report.
• Toxicological risk assessment development and review: Certified toxicologists prepare or review your risk assessments to ensure they are scientifically sound and regulator-ready.
• Methodology consulting: Support with selecting test methods, defining acceptance criteria, and justifying study design to align with ISO standards and regulatory norms. This ensures defensible data that meets both EU and U.S. requirements.

3. Assistance with Regulatory Interactions

A knowledgeable lab partner can support you in addressing regulatory questions and deficiencies:

• Pre-submission meeting preparation: Assistance with compiling documentation, developing talking points, and anticipating reviewer concerns ensures a more productive interaction with Notified Bodies or FDA reviewers.
• Response to Notified Body feedback: Labs can help prepare supplementary data or scientific justifications to address identified gaps effectively and efficiently.
• BER optimization: Ensuring your Biological Evaluation Report presents a clear, consistent, and defensible narrative, minimizing ambiguity and supporting a smoother regulatory pathway.

4. Choosing the Right Lab for Pre-Submission Services

Not all labs offer equal regulatory support. When selecting a partner, look for:

• Experience supporting EU MDR submissions across device classes: A lab with a broad track record understands nuances specific to different device categories.
• Direct interactions with Notified Bodies and familiarity with reviewer expectations: Labs that regularly engage with regulators can anticipate feedback and proactively address concerns.
• In-house certified toxicologists and regulatory specialists: Their expertise ensures that your risk assessments and justifications meet the highest scientific and regulatory standards.
• Proven processes for quality control and documentation consistency: Strong internal QA/QC systems improve the reliability of documentation and reduce the risk of discrepancies that lead to rejections.

5. Risks of Inadequate Submission Preparation

Failing to adequately prepare for regulatory submission carries serious consequences. Submissions with incomplete data, poor justification, or inconsistent reporting often result in questions, rejections, or lengthy deficiency letters. This can significantly delay market approval and increase costs due to additional testing or revisions. Worse, it can undermine regulator confidence in your overall quality system.

From a business perspective, these delays can impact product launch timelines, investor confidence, and competitive positioning. From a regulatory standpoint, deficiencies may lead to partial approvals, additional post-market commitments, or even outright rejection.

Final Thoughts

Getting biocompatibility right is more than just passing tests — it’s about building a defensible, science-based narrative regulators can trust. Partnering with a lab that offers pre-submission support allows manufacturers to anticipate and address reviewer concerns, reduce deficiencies, and accelerate time to market. Early collaboration with experienced experts ensures your submission tells the full story — clearly, scientifically, and credibly.

About the Author: Dr. Damian Matak

Dr. Damian Matak – an expert in medical device biocompatibility testing, serving as the CEO of ISO 17025-accredited and GLP-certified laboratories, including EBI – European Biomedical Institute and NABI – North American Biomedical Institute. As a member of the Polish Society of Toxicology and the I Local Ethical Committee, Dr. Matak contributes significantly to advancing safety standards in the biomedical field.