Reusable instruments: when clinical evidence seems obvious but isn’t

Written by HATEM RABEH, MD, MSc Ing

Your Clinical Evaluation Expert And Partner

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The pattern is always similar. The manufacturer submits a clinical evaluation report that relies heavily on device description, material composition, and sterilization protocols. Clinical data is either absent or reduced to a literature search with no clear appraisal. The Notified Body flags it immediately.

Why does this keep happening?

Because reusable surgical instruments sit in a regulatory grey zone. They are medical devices under MDR Article 2(1). They require clinical evaluation under MDR Article 61. But their perceived simplicity creates a blind spot. Manufacturers confuse ‘low risk’ with ‘no clinical evidence needed’. That confusion is expensive.

The regulatory expectation is not what you think

Under MDR Annex XIV Section 1, clinical evaluation is mandatory for all devices. There is no exemption for reusable instruments. There is no simplified pathway simply because the device has been used for decades. The regulation does not care about your perception of simplicity.

What the regulation requires is clinical data demonstrating safety and performance for the intended use, in the target population, under the conditions of use specified by the manufacturer.

For reusable instruments, that means you need to demonstrate:

• That the device performs its intended surgical function safely across the claimed number of reuse cycles
• That reprocessing does not compromise safety or performance
• That the device continues to meet essential requirements after repeated use, cleaning, and sterilization

This is not theoretical. These are the areas where Notified Bodies systematically look for evidence.

If you claim 500 reuse cycles, you need data showing that the device still meets essential requirements at cycle 500. If your instructions for use describe specific cleaning and sterilization procedures, you need data showing those procedures are compatible with device integrity.

Most clinical evaluation reports miss this completely.

Why equivalence rarely works for reusable instruments

Many manufacturers attempt to use equivalence under MDR Article 61(5) and MDCG 2020-5. They select a predicate device, claim technical and biological equivalence, and submit a comparative analysis.

This approach fails more often than it succeeds.

Here is why. Equivalence requires demonstration that the devices are equivalent in clinical, technical, and biological characteristics. For reusable instruments, technical characteristics include material composition, design, manufacturing process, and critically, reprocessing compatibility.

If your device uses a different steel alloy, a different surface finish, or a different joint mechanism, technical equivalence becomes difficult to demonstrate. If the predicate device was validated for 300 cycles and yours claims 500, equivalence breaks down.

Even if technical equivalence holds, you still need clinical data on the predicate device. Under MDCG 2020-5, that means sufficient clinical data to demonstrate safety and performance of the predicate. For devices that have been on the market for years, that data often does not exist in an analyzable form.

I have seen manufacturers submit equivalence claims based solely on functional similarity. Both devices are forceps. Both grasp tissue. Therefore, they are equivalent. This reasoning does not survive scrutiny.

The question is not what the device does. The question is whether the clinical data on the predicate device is sufficient and transferable to demonstrate that your device, with your specific design, materials, and claimed reuse cycles, is safe and performs as intended.

That is a much harder threshold to meet.

What clinical data actually looks like for reusable instruments

If equivalence is not viable, you need to generate your own clinical evidence. For reusable instruments, that evidence typically comes from three sources: pre-clinical testing, clinical experience data, and post-market surveillance.

Pre-clinical testing includes simulated use testing, mechanical testing over claimed reuse cycles, and reprocessing validation. This is not clinical data in itself, but it supports the clinical evaluation by demonstrating that the device maintains its technical characteristics under repeated use.

You need to show that after the claimed number of cycles, the device still meets functional specifications. If it is a cutting instrument, it still cuts. If it is a grasping instrument, it still holds tissue with the specified force. If it has articulating joints, those joints still function within tolerance.

This data is essential but insufficient. It demonstrates technical performance, not clinical safety and performance.

Clinical experience data includes retrospective analysis of device use in clinical practice. This can come from clinical studies, literature data, or structured collection of clinical outcomes from routine use.

For reusable instruments, the challenge is that most clinical literature does not isolate the contribution of the specific instrument. A paper on laparoscopic cholecystectomy outcomes does not tell you whether the specific forceps used contributed to safety or performance.

To make clinical literature useful, you need to appraise it specifically for adverse events or performance issues related to instrument failure, breakage, or malfunction. You need to analyze whether those events are attributable to design, materials, or reprocessing.

That requires critical appraisal, not just literature collection.

Post-market surveillance data is the third pillar. Under MDR Article 61(11), clinical evaluation must be updated throughout the lifecycle with data from post-market surveillance and PMCF.

For reusable instruments, that means systematic collection of field data on device performance, wear, breakage, cleaning efficacy, and any adverse events related to reprocessing or reuse.

This is where most manufacturers underinvest. They collect complaint data reactively. They do not structure PMCF to answer specific questions about device performance over lifecycle.

The PMCF trap for reusable instruments

PMCF planning for reusable instruments is often generic. The plan states that the manufacturer will monitor complaints, analyze trends, and review literature annually. That is not sufficient.

A PMCF plan must address specific gaps in clinical evidence. For reusable instruments, the gaps typically include:

• Real-world performance across the claimed number of reuse cycles
• Effectiveness of reprocessing procedures in maintaining safety and performance
• Detection of wear, corrosion, or material degradation in routine use
• Adverse events linked to instrument failure or malfunction

Your PMCF plan must describe how you will systematically collect data on these endpoints. That means defining data sources, collection methods, analysis frequency, and decision thresholds.

For example, if you claim 500 reuse cycles, your PMCF should include a method to track actual use cycles in clinical settings and correlate them with performance or failure events. If you do not have that data, you do not have confirmation that your claim holds in real-world use.

I have reviewed PMCF plans that state the manufacturer will ‘monitor device performance’. That statement means nothing. What specific performance parameter will you monitor? How will you measure it? What data will you collect? From which sources? At what frequency?

If those questions are not answered in the PMCF plan, the plan will not pass review.

How to structure the clinical evaluation report

A clinical evaluation report for a reusable surgical instrument should follow the structure in MDCG 2020-6, but with specific attention to lifecycle and reprocessing evidence.

Section 1 should define the scope, including the claimed number of reuse cycles and the reprocessing procedures specified in the instructions for use. These are clinical claims that require evidence.

Section 4 should include a detailed analysis of technical characteristics relevant to reprocessing. This includes material biocompatibility after repeated sterilization, mechanical integrity after simulated use cycles, and resistance to corrosion or degradation.

Section 5 should appraise clinical data specifically for instrument-related outcomes. If you rely on literature, show how the literature supports safety and performance of your device under repeated use conditions. If you rely on clinical experience, demonstrate that the experience is relevant to your device and your claimed lifecycle.

Section 6 should summarize residual risks and link them to PMCF. If you cannot fully demonstrate lifecycle performance before market entry, you must explain how PMCF will close that gap.

The report should not hide behind the device’s simplicity. It should confront the specific challenges of demonstrating safety and performance for a device that will be reprocessed and reused hundreds of times.

Final perspective

The assumption that reusable surgical instruments require minimal clinical evaluation is outdated. MDR does not recognize device simplicity as a justification for reduced evidence.

What matters is whether you can demonstrate, with objective evidence, that your device is safe and performs as intended across its claimed lifecycle. For reusable instruments, that lifecycle includes hundreds of reuse and reprocessing cycles.

If your clinical evaluation report does not address that lifecycle explicitly, it will not meet the standard expected by competent reviewers. And that standard is not negotiable.

Peace,
Hatem
Clinical Evaluation Expert for Medical Devices
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