Clinical benefit for accessories/applied parts

Stephan

Registered
Hello to all,

a discussion came up in our company about the necessity for definition of a clinical benefit for accessories which are part of a therapy-system. These accessories for electromedical devices and are applied parts according to IEC 60601-1 (e.g. ECG Electrodes, or other sensor electrodes, or simple cables). These accessories can only reach their intended purpose, when working integrated in the therapy system, they are "stupid" parts themselves. According to MDR these accessories can be classified from Class I up to Class IIb. It is quite hard to define a clinical benefit without looking at the whole system and even our NB told us, that we do not need necessarily a clinical benefit. But in our opinion we will need a clinical benefit, otherwise we cannot argument with risk/benefit ration in terms of Riskmanagement according to ISO 14971. In addition it is nearly impossible to get any useful literature for PMS assessment or the clinical evaluation report, as most papers concentrate on the electrical medical device itself and not on the applied parts in particular. You will never receive data on a positive, measurable, patient relevant clinical outcome, as required in MDR, for a possible clinical benefit.

I hope my description of the problem is understandable.
Is there any experience you could share for defining clinical benefits for accessories? Thank you for taking some minutes to think about it ;)

Thank you
 

Vetty007

Involved In Discussions
The answer is actually quite simple, the clinical benefit is that the treatment system only achieves its full functionality with this accessories. I don't know if this is really an accessory in terms of MDR, according to which it supports the functionallity of a device. But in my optinion its not an accessory, if its fundamentally needed for the device to work (as this is far beyond a supportiv function) and thus needs to be supplied with the device initially, in order for it to be functional at all, and in this respect it would be included in the technical file of the device. Even if the accessory is supplied separately, then this is only to ensure continued functionality by replacing components that are subject to wear (risk management - risk mitigation by recommending regulary changes of these components to guarantee full functionallity).
I have similar cases, in which this is done this way, despite the accessories could have been used in different other uses and one could be surprised as the accessory is a very simple equipment, but labelled as IIa device, which mostly is seen as not classified or only as class I, but not that high class, but which is due by including it in the file of the "main" device.
 

Aliken

Involved In Discussions
Hi Stephan,

The MDR term "clinical benefit" refers to the product (medical device) only and not to one or more of its accessories separately.
You may use the word "benefit" in a lay fashion, but this is not to be confused with the "clinical benefit" that MDR is referring to.
See MDR definitions of accessory and clinical benefit below:

Article 2(2)‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);

Article 2(53) ‘clinical benefit’ means the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health;
 

Stephan

Registered
Thank you Aliken and Vetty007 for your replies.

Hi Stephan,

The MDR term "clinical benefit" refers to the product (medical device) only and not to one or more of its accessories separately.
You may use the word "benefit" in a lay fashion, but this is not to be confused with the "clinical benefit" that MDR is referring to.
See MDR definitions of accessory and clinical benefit below:

Article 2(2)‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);

Article 2(53) ‘clinical benefit’ means the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health;

Article 2(53) refers to "devices" and if one refers to Article 1(4), I do not think that accessories are excluded from the definition of "clinical benefit".

Article 1 (4) For the purposes of this Regulation, medical devices, accessories for medical devices, and products listed in Annex XVI to which this Regulation applies pursuant to paragraph 2 shall hereinafter be referred to as ‘devices’.
 

Aliken

Involved In Discussions
I understand your logic. However, if we follow it to its full potential, we will end up having GSPR, PMS, PMCF, Risk, etc., for each accessory of the product, which was not, in my opinion, the legislator's intention. Each accessory contributes to the final product's overall "clinical benefit," benefit-risk ratio, etc.. of the product, and we can describe such contributions in TD. Still, I would reserve the term "clinical benefit" for the final product only. I think that your approach may apply to a greater extent to the products contained in the "Procedure pack" (MDR 2(10) or "System" (MDR 2(11)). Similarly, for devices incorporating a medicinal product (Rule 14), you need to justify (clinical benefit, etc) the addition of medicinal substance(s).
 
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