Class I PMCF: Why exemption does not mean absence

Written by HATEM RABEH, MD, MSc Ing

Your Clinical Evaluation Expert And Partner

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The confusion is understandable. MDR Article 61 states that class I devices may be exempted from the requirement to conduct clinical investigations under certain conditions. Manufacturers read this and assume it extends to post-market clinical follow-up. It does not.

What they miss is that clinical evaluation is a continuous process. The MDR does not distinguish between device classes when it comes to the obligation to generate, collect, and analyze clinical data throughout the device lifecycle. PMCF is not a class IIa and above requirement. It is a clinical evaluation requirement that applies to all devices placed on the market.

Where the Exemption Actually Applies

Article 61 deals with pre-market clinical investigations. For certain class I devices, particularly those with established equivalence to devices already on the market and with sufficient clinical evidence, the requirement to perform a new clinical investigation may be waived. The device can enter the market based on existing clinical data, literature, and equivalence demonstration.

This exemption is limited in scope. It addresses what you must do before the device is marketed. It says nothing about what happens after.

Once the device is on the market, the clinical evaluation continues. The manufacturer must monitor real-world performance, confirm safety and performance claims, identify emerging risks, and update the clinical evaluation report accordingly. This is PMCF. And no exemption from pre-market clinical investigation removes this obligation.

What PMCG 2020-7 Says About This

MDCG 2020-7 provides detailed guidance on post-market clinical follow-up. The document does not carve out class I devices. Instead, it explains that PMCF is part of the clinical evaluation process, which applies to all medical devices regardless of classification.

The guidance makes clear that PMCF is not optional. It is a structured method for proactively collecting and evaluating clinical data from devices already placed on the market. The scope and depth of PMCF activities must be proportionate to the risk class and the specific characteristics of the device, but proportionality does not mean absence.

For a class I device, PMCF may be less intensive than for a class III implantable. But it must exist. It must be planned. And it must generate usable evidence.

What Proportionate PMCF Looks Like for Class I

Proportionality is the key concept. A class I non-sterile, non-measuring device with decades of safe use and low inherent risk does not need the same PMCF infrastructure as a class IIb active therapeutic device. But it still needs something.

A proportionate PMCF plan for such a device might include:

Systematic collection of complaint data with root cause analysis and trending. Regular review of device returns and field performance. Literature surveillance to identify new safety signals or performance concerns. Periodic clinical evaluation report updates that integrate this data and confirm ongoing acceptability of the benefit-risk profile.

This is not burdensome. It is structured vigilance. It demonstrates that the manufacturer is not assuming safety based on past performance but actively verifying it.