Why Your Equivalence Contract Might Not Give You What You Need

Written by HATEM RABEH, MD, MSc Ing

Your Clinical Evaluation Expert And Partner

in
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This scenario plays out more often than it should. The contract looked solid. Legal approved it. The manufacturer agreed to share data. But when you sit down to write the clinical evaluation report, you discover gaps that make the equivalence demonstration incomplete.

The problem is not always bad faith. It is usually misalignment between what regulatory professionals need and what contracts actually secure.

The Regulatory Foundation: What Equivalence Demands

Under MDR Article 61 and Annex XIV, demonstrating equivalence requires access to specific technical, biological, and clinical data from the equivalent device. You need enough information to demonstrate that your device and the equivalent device have the same technical characteristics, biological properties, and clinical performance.

MDCG 2020-5 clarifies this further. Equivalence is not a surface-level comparison. It requires detailed analysis across multiple domains. You must show that any differences do not affect clinical safety or performance.

Here is where contracts often fail: they focus on data transfer, not on regulatory sufficiency.

What Goes Wrong: The Gap Between Legal and Regulatory Language

Contracts are negotiated by legal teams. They use terms like “confidential information,” “proprietary data,” and “reasonable access.” These terms protect business interests, but they do not map directly to regulatory obligations.

When the contract says you will receive clinical data, what does that include? Does it include the full clinical evaluation report? The underlying literature search? Access to raw study data? The clinical risk management file?

Often, the contract does not specify.

Manufacturers interpret “clinical data” narrowly. They provide summaries. They share published articles. They give you a redacted clinical evaluation report with key sections removed for confidentiality.

You receive something. But not enough to write a compliant equivalence demonstration.

The Technical Data Problem

Equivalence starts with technical comparison. You need design specifications, materials, manufacturing processes, and performance testing results. Contracts often cover clinical data but ignore technical data.

Without full technical documentation, you cannot establish that the devices share the same technical characteristics. The equivalence claim collapses before you even reach clinical performance.

Even when technical data is mentioned, the contract may limit access to “non-proprietary technical information.” But proprietary details are often what determine equivalence. If the manufacturer holds back key design elements, you cannot complete the analysis.

The Biological Property Problem

Biological evaluation is another critical layer. Equivalence requires demonstrating that both devices have the same biological properties, including biocompatibility.

Contracts rarely address biocompatibility files. You may receive a declaration of conformity or a summary statement. But you need the actual test reports, risk assessments, and material characterizations.

If the manufacturer conducted a biological risk assessment under ISO 10993-1, you need to see that file. You need to compare it to your own. Without it, the equivalence demonstration remains incomplete.

The Clinical Data Detail Problem

Let’s assume the contract does grant access to clinical data. What arrives?

Often, you receive a clinical evaluation report. It is marked confidential. Sections are redacted. The literature search is summarized, not provided in full. Clinical studies are referenced, but the study protocols and raw data are withheld.

This creates a dilemma. You can cite the equivalent device’s clinical evaluation report. But you cannot independently verify its conclusions. You cannot assess the quality of the underlying evidence. You cannot demonstrate that the equivalent device’s clinical data actually supports your device.

Notified Bodies will ask: “How do you know this data is reliable? How do you know the literature search was complete? How do you know the clinical studies were properly conducted?”

If you cannot answer these questions, the equivalence claim weakens.

The Update and Maintenance Problem

Equivalence is not static. If the equivalent device is modified, if new clinical data emerges, if post-market surveillance identifies risks, your equivalence claim may be affected.

Contracts often address the initial data transfer but ignore ongoing updates. The manufacturer has no contractual obligation to inform you of changes. You may continue relying on equivalence long after it is no longer valid.

This is a regulatory time bomb. When a Notified Body audits your PMS or PMCF, they will ask: “How do you monitor the equivalent device? How do you know it has not changed?”

If your contract does not secure ongoing access to updates, you cannot answer.

What Should Be in the Contract

The solution is to align contract language with regulatory requirements before the agreement is signed. This requires collaboration between regulatory, clinical, and legal teams.

Here is what the contract should explicitly cover:

Specific Documentation

List the exact documents you need. Do not rely on vague terms like “clinical data.” Specify: clinical evaluation report, literature search protocol and results, clinical study protocols and reports, biocompatibility files, technical design files, risk management files, and post-market surveillance data.

If the document exists, it should be in the contract.

Level of Detail

Specify that data will be provided in full, not as summaries. Redactions must be limited and justified. If certain information cannot be shared due to legitimate confidentiality concerns, the contract should outline alternative mechanisms for verification.

Ongoing Access

Include provisions for updates. The manufacturer must notify you of design changes, new clinical data, or safety signals. Access to revised clinical evaluation reports and updated PMS data should be secured.

Audit and Verification Rights

You should have the right to verify the data’s accuracy and completeness. This might include the ability to audit the manufacturer’s files or request clarifications from their regulatory team.

Notified Bodies expect manufacturers relying on equivalence to have robust mechanisms for ensuring the data is trustworthy. Contracts should support this.

The Timing Problem

One more issue: contracts are often negotiated late in the process. By the time regulatory teams realize what data they need, the legal framework is already set.

This creates pressure to accept incomplete terms. The alternative is renegotiation, which delays the project and strains the business relationship.

The solution is early involvement. Regulatory and clinical teams should define data needs before negotiations begin. Legal teams should understand the regulatory context. The contract should be built around compliance, not retrofitted to it.

What Happens When the Contract Fails

If you realize too late that the contract does not secure the right data, your options narrow.

You can try to renegotiate. But the manufacturer has already fulfilled their obligation. They have little incentive to provide more.

You can abandon the equivalence route. This means conducting your own clinical investigation, which is time-consuming and expensive.

Or you can proceed with incomplete data and hope the Notified Body accepts it. This rarely ends well. Notified Bodies are trained to identify gaps in equivalence demonstrations. When they find them, the submission stalls.

The cost of a poorly written contract is measured in months of delay, additional studies, and regulatory risk.

A Final Reflection

Contracts are business tools. Regulations are compliance frameworks. When the two do not align, compliance suffers.

Accessing clinical data for equivalence is not just a legal transaction. It is a regulatory requirement that must be met with precision and foresight. The contract is the mechanism that makes this possible, but only if it is written with regulatory needs in mind.

The next time you negotiate access to equivalence data, ask yourself: does this contract give me what the regulation requires, or just what the legal team thinks is reasonable?

The answer determines whether your equivalence claim will hold up when it matters most.

Peace,
Hatem
Clinical Evaluation Expert for Medical Devices
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