MEDDEV 2.7/1 rev 4 - Clinical Performance & Clinical Safety Claims

[FoGia]

Hi there,

I've pondering the MEDDEV 2.7/1 rev 4 on clinical evaluation for quite some time now but the concepts of clinical performance & clinical safety claims still elude me.
The guideline points to the definitions of clinical performance (from ISO 14155) and clinical safety (from MEDDEV 2.7/2) without providing clear examples as to when a claim can be considered a performance or safety claim. It's especially confusing since the two concepts are used together throughout the guideline. I can't find on the web, on the site of IMDRF or other references to these concepts. What am I missing?

An example: are biocompatibility/sterilizability/compatibility performance or safety claims? Following the definitions I'd say those are performance claims (the device performs as intended). They're however not part of the intended use and I'm tempted to classify them as clinical safety claims since they're not serving the primary performance intended by the manufacturer.

But from the defintion standpoint, clinical safety claims aren't "freedom from unacceptable risks" just another way to describe the indications for use?

Could you help me articulate these notions?

Thanks

 

[shimonv]

Hi Fogia,
Here is how I understand it although clinical affairs is not my strong suit:

Clinical Performance: Behavior of a medical device or response of the subject(s) to that medical device in relation to its intended use, when correctly applied to appropriate subject(s).

Clinical Safety: Freedom from unacceptable clinical risks, when using the device according to the manufacturer’s Instructions for Use.

In practical terms, I would say that clinical safety is evidence for risk mitigation, i.e. that you are not 'achieving' unintended, unacceptable results. For example, biocompatibility, sterilization and electrical safety.
Clinical performance is evidence that the device is archiving its intended use. For example, bench testing and clinical outcome results.

Hope it helps.

-Shimon

 

[FoGia]

Thanks for your reply Shimon!

This makes sense although for some claims this is a thin rope to walk on.
Regulators must be aware of this since they keep on rewording the definitions:
Clinical performance:

Meddev 2.7/1 rev 3:
The ability of a medical device to achieve its intended purpose as
claimed by the manufacturer.

Meddev 2.7/1 rev 4:
Behavior of a medical device or response of the subject(s) to that medical device in relation to its intended use, when correctly applied to appropriate subject(s).

MDR:
'clinical performance' means the ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients, when used as intended by the manufacturer;

It seems that the definitions evolve toward a more medical perspective, there needs to be a link with clinical benefits. Does that imply that performance claims must be linked to clinical benefits(this can be challenging to demonstrate for devices that have clear indications for use but represent only a part of the treatment. The MEDDEV 2.7/1 rev 4 stressess that out as well and goes on even further on page 47 about Conformity assessment with requirement on performance:

Clinical performance incudes any claims about clinical properties and safety of the device that the manufacturer intends to use.

From that I understand that clinical safety claims are part of the clinical performance claims.

I'll probably stick to your interpretation althoug I must admit some degree of confusion wtill remains.

 

[shimonv]

I'll probably stick to your interpretation although I must admit some degree of confusion will remains.

What can I say... sometimes we overwork ourselves in trying to separate different yet overlapping terms.

It always comes down to safety and effectiveness. Safety is the evidence that you are not achieving undesired results and effectiveness is the evidence that are achieving the desired results. And yes, sometimes they overlap. And yes, performance is the bigger deal because in the end you need to show that the benefit is greater than to risk, and there is always a risk.

Cheers,
Shimon