CLINICAL EVALUATION - VACCUM PLANTS

Oneves

Starting to get Involved
#1
Dear all,
If you needed to argue that a vacuum production plant (source) does not have to be the subject of clinical evaluation, what would you say to the auditor?
 
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Raisin picker

Quite Involved in Discussions
#2
What the h... is a vacuum production plant? With my limited command of the english language, I'm not sure wheter it is a plant that produces vacuum cleaners or a device that creates a vacuum (or a bush that survives in vacuum).
What regulation (country)? What's the purpose of the plant? How is it related to someone that can ask for a clinical evaluation?

In other words, could you please provide some more context?
 

Oneves

Starting to get Involved
#3
Central Medical Vacuum Supply System (or plant) is used to provide a reliable and continuous suction in various departments of a hospital.
This is classified as class IIb medical device.
According to MDD/MDR a clinical evaluation is needed. Since this is vacuum (space entirely devoid of matter), there is no medicine and it is an equipment that is not in contact with the patient, what will the clinical evaluator look at?
 

Zero_yield

No cost too great...for Quality
#4
I'll play devil's advocate for a minute:

1. How do you know your vacuum system is reliable and provides continuous suction (meets its purpose, appropriate performance)?
2. The device has clinical application. Why wouldn't it have a clinical evaluation of its safety?

There's probably good answers to all of these, and these good answers need to be compiled into a documented justification.

I AM NOT AN EXPERT IN THE FOLLOWING. Anyone who understands better, feel free to correct me. I have some EU MDR training and experience, but this particular niche I'm just dipping my toes into.

From what I understand, you always need a clinical evaluation, attached to your Technical File documentation. Clinical evaluation doesn't just mean using a device on a bunch of people and seeing if it works and doesn't cause side effects (a clinical investigation) - it also involves explaining why your product will be able to do its job safely and effectively compared with similar devices on the market. Your company may piggy-back off of other's research for similar devices, but I'm not seeing anything that says you can skip the evaluation. You may want to check your technical file to see if you have such a justification.

3. A clinical evaluation shall follow a defined and methodologically sound procedure based on the following:

(a)
a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where the following conditions are satisfied:

it is demonstrated that the device subject to clinical evaluation for the intended purpose is equivalent to the device to which the data relate, in accordance with Section 3 of Annex XIV, and

the data adequately demonstrate compliance with the relevant general safety and performance requirements;

(b)
a critical evaluation of the results of all available clinical investigations, taking duly into consideration whether the investigations were performed under Articles 62 to 80, any acts adopted pursuant to Article 81, and Annex XV; and

(c)
a consideration of currently available alternative treatment options for that purpose, if any.
Taken from here: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=uriserv:OJ.L_.2017.117.01.0001.01.ENG
 

Raisin picker

Quite Involved in Discussions
#5
As zero_yield says: Under MDR, every device does have to have a clinical evaluation (and a CER). But look at
  • Article 61 (1): define the amount of data needed,
  • Article 61 (10): CER without clinical data and
  • MDCG 2020-6: well-established technology.
You can get away with a small scale CER, as long as your justification is good. Should work with that type of device.
 
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