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Going for CE on MD Class 1 ISO 20957-1&2

#1
The company I work for manufacturers Pilates equipment for home, studio and rehabilitation clinics. The equipment has no electronics, sterilization or measurement features its purely mechanical rollers and pulleys which I believe falls under Med. Dev. Class 1. Being Class 1 I understand that it does not need to be certified by a third party test lab but it does need to be compliant to ISO 20957-1 & 2 - is that correct? I have paid for the ISO 20957-1 & 2 standards so that I can at least see what the product has to comply with - which takes quite a bit to understand it. I know I need to create a Technical Construction File but what else do I need to do to be in compliance and put CE on the products? I also saw some regulation changes for next year MDR 2020 - does that affect Class 1 as well?
 

Ronen E

Problem Solver
Staff member
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#2
The company I work for manufacturers Pilates equipment for home, studio and rehabilitation clinics. The equipment has no electronics, sterilization or measurement features its purely mechanical rollers and pulleys which I believe falls under Med. Dev. Class 1.
Whether such a specific product is officially considered a Medical Device, and what class it is, depend on its Intended Use, which is normally concluded from it's associated documentation including labels, manuals/IFU, marketing materials, website contents etc. It's not necessarily a question of whether it involves electronics, sterilization or measurement features. To correctly classify you'd need to go through the classification rules in the MDR (or the MDD, but it's likely late for that).
TBeing Class 1 I understand that it does not need to be certified by a third party test lab but it does need to be compliant to ISO 20957-1 & 2 - is that correct?
If indeed it's a class 1 device then based on your description what you DON'T require is the Notified Body certification (EC certificate). Whether a given device needs a 3rd party test lab certification is a separate matter, not directly related to its class. Based on your description I guess you don't need the latter either, though you might benefit from it (depends on the specifics). Compliance with any ISO standard is not mandatory in this context, though again you might benefit from it (especially if the device IS subject to NB scrutiny). Either way, currently no harmonized standards list is available under the MDR so it's impossible to say which such standards (ISO or otherwise) might benefit you. Voluntary compliance with a current ISO standard might nevertheless be a good way to show meeting some relevant regulatory (MDR) requirements (though for non-SMR class 1 devices there won't be anyone to show it to, LOL).
I know I need to create a Technical Construction File but what else do I need to do to be in compliance and put CE on the products? I also saw some regulation changes for next year MDR 2020 - does that affect Class 1 as well?
Yes, it does. "To be in compliance and put CE on the products" (assuming that it is in fact a Medical Device) you'll have to go through the MDR and make sure you are compliant with all the applicable requirements. You'll also need to make sure that you are compliant with any and all other EU directives/regulations that apply to your device and include CE marking provisions (the candidate list is 20-something strong - need to review to know which ones apply).
 
#3
Thanks for your response Ronen, I appreciate the feedback. I have researched other Pilates manufacturers and there are a number out there that also have CE Med Dev Class 1 - I don't like assuming things but it's interesting that others have the same classification. I'm still taking your advice and going to research the MDR.
I also reviewed the harmonised standards and couldn't find a definitive standard but did find a report from a Pilates equipment manufacturer stating compliance to the EN 20957-1 standard for Stationary Training Equipment. I am going to pursue the same standard as it's the closest I can find and the test criteria is about as close as it gets to what components make up Pilates equipment.
I reviewed the MDR Annex VIII Classifications Rules and saw in Chapter 1.1 that 'continuous use for less than 60 minutes' would apply, Chapter 2.4 ‘Active therapeutic device’ means any active device used, whether alone or in combination with other devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or disability' would also possibly apply as the equipment is used for post surgery or non-impact muscle therapy.
So, currently (pre May 2020 regs), given MDD Class 1 with reference to EN 20957-1&2, I should be able to create the TCF, test against standard EN 20957, create a DoC, establish an EU representative, register with a Competent Authority and place the CE label. Seems too straight forward somehow? :)
 
#4
So I spent some time looking at the new MDR 2017/745 regulations and there's quite the step up from the older MDD. From what I understand for a MDD Class 1 (not 1s, 1m or 1r), the steps below should get me through the process.

Check and confirm that the product is a medical device.
Confirm that the product is a class 1 medical device.
Ensure that the general safety and performance requirements have been met (in my case EN 20957-1 & 2).
Perform clinical evaluation.
Prepare technical documentation.
Prepare instructions and labeling.
Check compliance with general obligations for manufacturers (Machinery Directive).
Draw-up the EU Declaration of Conformity (in country languages where sold).
Place the CE marking on the device and packaging.
Register devices and manufacturer in EUDAMED.
Collect and evaluate post-market data.
Create a vigilance system for documenting Field Safety Corrective Actions until EUDAMED is operational.
Create non-conforming products procedures ( we currently have a QMS in place with CAPA).

Chirp in anyone if I have missed anything.
Cheers, Nigel
 
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