CE Mark for Class 1 medical device

[Nigel-S]

I posted this on one of the medical forums but thought it may also be appropriate here too - moderators, please feel free to remove if its not deemed appropriate.

The company I work for designs and manufactures Pilates equipment for the home, studio and rehabilitation clinics. We are pursuing CE compliance but under Medical Device Class 1 (low risk). As such I have been trying to understand the roadmap to getting CE applied on the products.

I spent some time looking at the new MDR 2017/745 regulations and there's quite the step up from the older MDD 93/42/EEC. From what I understand for a Medical Device Class 1 (not 1s, 1m or 1r), the steps below should get me through the process.

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

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

 

[yodon]

Apologies, I recall seeing your other post but was a bit baffled about Pilates equipment being classified as a medical device. Are you sure about that?

What is class 1s, 1m, and 1r? You are correct that the MDR is a step up from the MDD!

In general, your list is ok. Your QMS should be compliant with 13485 (harmonized standard) - not sure why you singled out CAPA. If you're not in the EU, you may need an Authorized Rep. There's also the concept of a Person Responsible for Regulatory Compliance (PRRC). There are more postmarket activities than just collecting data and documenting FSCAs. As part of labeling and getting into EUDAMED, you need a UDI. Plenty of other details to consider but without knowing more about the operation, may not be helpful to try to discuss.

Would definitely take that first step and confirm the equipment would be classified as a medical device. If you don't have to, the path is much easier.

 

[Nigel-S]

Hi Yodon, thanks for your response. Your question re whether or not it is classed as a medical device is spot on. We do have equipment that is specifically designed for the rehab professionals and are advertised as such and purchased for that but does that make it a medical device - I guess the jury is still out there. There is a lot of evidence and written papers to support the benefits from Pilates for post surgery/injuries. There are competitors that already have CE MD Class 1 but that's under the current MDD which I hate to say it, is rather loosey goosey.

Class 1 will also have 1sterile, 1measurement and 1reusable going forward.
We do have a QMS but I don't believe that we have to be checked for its compliance to 13485 but we are checking to make sure that we do regardless.
We currently have a 3PL distributor located in the UK as we manufacture in North America. However with the Brexit dilemma, we are also looking for a 3PL inside the EU who will also act as our Authorised Rep.
I did read about the PRRC too which is why I want to complete the third party testing to 20957-1 & 2 so whoever is deemed the PRRC can see that due diligence was done. I have been in the compliance field for 7+ years but dealing with the LVD not medical devices.
We do have the 2D barcode on the product but I am investigating what data is inside the barcode and also having it human readable underneath.

I will do some more research on the medical device and see if I can post some information. It's a fine line and I know that its unlawful to put the CE if it's not really a medical device. I wish there were more categories to choose from.....
Cheers,
Nigel

 

[dgrainger]

What claims are you intending to make about the equipment? MHRA borderlines guidance states for "Products for sports or leisure":

In general, products for sport or leisure purposes are not considered to be medical devices. However, in some cases, products aimed at sports people may be considered to be medical devices. This is usually the case where specific claims are made for the treatment of pain or injury and the product acts in a physical manner. Examples of products considered to be medical devices are:​

• heat / cold pads for pain relief
• bandages for sprains and similar
• support bandages
• gym equipment placed on the market specifically to measure, for example, heart rate or breathing rate. (Gym equipment that contains within it an element that measures heart rate is not a medical device because its primary purpose is as a piece of fitness equipment, not principally to measure a physiological function. Blood pressure monitors, even if intended to be used in a gym, however, would be considered to be medical devices).

If you want to claim that the equipment is for treatment of post surgery/injuries (or something else) then it will qualify a medical device.

 

[Nigel-S]

What claims are you intending to make about the equipment? MHRA borderlines guidance states for "Products for sports or leisure":

In general, products for sport or leisure purposes are not considered to be medical devices. However, in some cases, products aimed at sports people may be considered to be medical devices. This is usually the case where specific claims are made for the treatment of pain or injury and the product acts in a physical manner. Examples of products considered to be medical devices are:​

• heat / cold pads for pain relief
• bandages for sprains and similar
• support bandages
• gym equipment placed on the market specifically to measure, for example, heart rate or breathing rate. (Gym equipment that contains within it an element that measures heart rate is not a medical device because its primary purpose is as a piece of fitness equipment, not principally to measure a physiological function. Blood pressure monitors, even if intended to be used in a gym, however, would be considered to be medical devices).

If you want to claim that the equipment is for treatment of post surgery/injuries (or something else) then it will qualify a medical device.

Thanks for the information from the MHRA, I just read through their guidelines.
I took off the table our home and studio versions of Reformers.
However, we do have our 'Pilates Rehab Reformer' which has been designed specifically for the medical field and part of our advertising is "With a higher carriage height, these Reformers offer easy access for injured and mobility-challenged clients. Perfect for rehabilitation and physio clinics, medical facilities or those requiring enhanced accessibility for their clients."
So if I read the "Intended Use" correctly and given the design for the Rehab Reformer was aimed specifically at the medical profession, our Rehab Reformer would count as a Medical Device.

 

[Watchcat]

Yes, when you sell it for rehab, it's a medical device. What makes a medical device a medical device is a medical purpose. If equipment is intended (aka "sold" or "advertised") for use by healthy people to stay trim, slim, in shape, etc, it is not a medical device. However if it is intended for use in patients, to help them recover from injury, stroke, etc, then in most jurisdictions (and under the MDR), it is a medical device. It is the regulatory difference between a chair with wheels and a wheelchair, although the two may be physically identical. So you are solid on that.

As for what you need, since it is a Class I, non-sterile, non-measuring, non-reusable device, I don't think (it's your device, you must confirm this for yourself) that you need a notified body. In that case, it is regulated in mostly theory. It will get no attention from regulators as long as it has no serious problems, especially safety problems. However, should that happen, you definitely want to have your MDR ducks in a row. The regulators will already be unhappy with you over the problems, and will be easily made much more unhappy if they find non-conformance. (Sort of like getting pulled over for speeding, and then things go very bad when it turns out your license has expired. Or you don't even have one.)

Even then, their expectations would be somewhat modest. The reporting requirements are key. If you weren't reporting, they will think you were hiding something. Also important is anything else that involves safety, because if you weren't on top of that, then it's your fault that the device had safety problems. I would also make an extra effort to stay on top of how your device is performing, because, if safety problems develop, you don't want the regulators to be the first to know. Similarly, if it has safety problems and your customers sue you, and then the regulators hear about it and show up and decide you haven't been conforming, not good for you.

Otherwise, make a good faith effort to conform and don't lie awake nights. It seems that you actually want to conform, which puts you ahead of some other self-certified medical device manufacturers.

For you, ISO 13485 certification would seem to be more of a competitive decision than a regulatory decision. If your competition has it (and it means anything to your customers), you probably want to have it too. If they don't, then only if you think it might give you a competitive edge. The regulators might be more comfortable with ISO 13485 certified, if they ever showed up to look, because otherwise they would have to assess your "homegrown" QMS for themselves, if they even know how. Again more of a risk-based business decision than a regulatory matter. It is not required.

 

[Nigel-S]

Hi Watchcat, thanks for your input and sorry for the late response - a knee replacement got in the way.
I have been doing some internet trolling and have found a number of controlled trials have a positive outcome for patients using Pilates equipment. I will use those references in the clinical evaluation as to the validity of a medical device.
We have been making and selling the equipment for over 25 years with zero customer complaints over safety which is a great track record and also gives me that peace of mind that by doing the safety test IEC 20957-1&2 as well, will provide proof of due diligence in respect to the Directive.
We also have a QMS in place but that isn't part of the MD Class 1 requirement but is a nice to have.
Now I need to investigate how to build the Technical Construction File and understand its contents.
Cheers, Nigel

 

[Watchcat]

A couple of irrelevant comments:

Internet surfing. Trolling implies a negative intent.

Life got in the way, maybe in the form of a knee replacement, but easier to say life, and, at that level, everyone can relate.

Did you ever confirm whether you need a notified body? I'm fuzzy on how many Class I devices still need them. It could be all of them, or it could just be that those who didn't under the MDD and do under the MDR are screaming so loudly, it just sounds like all of them.

Sounds like you are on the right track. Best of luck to you! And your knee...

 

[Nigel-S]

A Class 1 device does not need a NB. A Class 1s, 1m, 1r does need a NB involved.

 

[Watchcat]

Thanks. I think Class I SaMDs need one too. (Talk about screaming.) But I was guessing hardware Class I devices, other than the ones you have listed, did not. And yes, just too lazy to look it up. Don't really need to know, just curious, and really who wants to dig through the MDR out of mere curiosity?