Clinical Evaluation MDR
- Thread starter lennsy
- Start date
Theoretically your deadline is in 2024. The additional year (until May 2025) is for (further) Making Available on the Market - further sales/transfers after the first one in the EU. But you actually can't wait until May 2024 - if you intend to get certified under the MDR you have to already have a "good quality" application submitted to your NB a year before the deadline (meaning in May 2023 latest). "Good quality" means that the application was already checked at least once by the NB and it was confirmed that (a) it includes all the elements it should, and (b) all these elements seem to be complete and contain the information that the NB needs for reviewing the TD etc.
If I was you, I'd start preparing my application tomorrow morning (if you haven't already), in full accordance with the MDR. I think that it's better to start fresh than to try to draw conclusions about the clinical evaluation from your existing MDD certification. You can probably use some of the clinical data and maybe some parts of existing documentation - there are no rules against that. Review the MDR clinical evaluation requirements carefully and prepare your CEP and CER accordingly, using what you can from what you already have. During this process you will find out if that's enough or you need to collect more data and maybe also initiate a clinical investigation.
If your existing clinical evaluation was aligned with MEDDEV 2.7/1 rev 4 your are in a good place, because this still represents the state of the art to a large extent. There is relevant additional guidance from MDCG, but there's still no MDCG replacement for MEDDEV 2.7/1.
Thank you Ronen for those information, under MDD this IIb implantable device has not enough clinical data so we afraid that it could not pass the certification, so in order to reduce costs we would remove this product off the market temporarily (after 2024)
So my question is, if we adopt this solution, could we use previous data if we wanted to remarket this device, or we will be in the obligation to do new clinical investigations since the device will be no more a legacy device.
Thank you in advance
Mangafanga
Starting to get Involved
It's not mandatory to demonstrate equivalency. You can probably show a Similar Benchmark based on Intended Use and clinical characteristics, using publicly available data.
Let me know if you need any support with this, we can connect.
Let me know if you need any support with this, we can connect.
I think that a temporary suspension from the market (and re-introduction under the MDR when you are ready) should have no effect, as long as the re-introduced device is identical (i.e. no design/process changes). If you introduce minor changes, you might be able to get away with demonstrating equivalence (see MDCG guidance). Other than that, when you prepare your MDR submission (e.g. CEP and CER) just use everything you already have. If that won't be enough, you might end up having to initiate a clinical investigation. There's no "general answer", it depends on what you have (or will have when you do it).
Hello,
Can one assume that for a Class I device that is identical to other existing devices in the market except the material, can one choose to perform a clinical evaluation based only on literature review? (A PMCF study is planned after it is CE marked). We could not choose the equivalence route since biological equivalence cannot be claimed (clinical and technical can be claimed though). Thank you so much in advance for your input!
Can one assume that for a Class I device that is identical to other existing devices in the market except the material, can one choose to perform a clinical evaluation based only on literature review? (A PMCF study is planned after it is CE marked). We could not choose the equivalence route since biological equivalence cannot be claimed (clinical and technical can be claimed though). Thank you so much in advance for your input!
Raisin picker
Quite Involved in Discussions
No. Formally, you need clinical data. And according to Article 2 (48), clinical data comes from the device under evaluation or an equivalent device.
You are sure you cannot claim equivalence for your device? According to Annex XIV (3) "The characteristics listed in the first paragraph shall be similar to the extent that there would be no clinically significant difference in the safety and clinical performance of the device."
You will have a good reason for your choice of material. Explain that in detail in the CER/equivalence discussion.
With a different material, I guess you cannot claim WET according to MDCG 2020-6.
Having said that, I regularly see devices that are equivalent/identical to all other devices on the market (CER), but much better (marketing). Be aware of Article 2 (12): "‘intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation;"
You are sure you cannot claim equivalence for your device? According to Annex XIV (3) "The characteristics listed in the first paragraph shall be similar to the extent that there would be no clinically significant difference in the safety and clinical performance of the device."
You will have a good reason for your choice of material. Explain that in detail in the CER/equivalence discussion.
With a different material, I guess you cannot claim WET according to MDCG 2020-6.
Having said that, I regularly see devices that are equivalent/identical to all other devices on the market (CER), but much better (marketing). Be aware of Article 2 (12): "‘intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation;"
Thank you so much for your reply.
According to MDR Annex XIV Part A
Biological: the device uses the same materials or substances in contact with the same human tissues or body fluids for a similar kind and duration of contact and similar release characteristics of substances, including degradation products and leachables.
It requires the same material, and even if I try to claim equivalency using ISO 10993, the material supplier states that our material is not equivalent to the clinical equivalent device.
Could I state that as long as both materials are biocompatible, then we can claim equivalency? Doesn't seem right but perhaps anyone has experience with this?
Raisin picker
Quite Involved in Discussions
Since we do neither know the type of device nor the materials in question, we cannot answer that question. I have seen the claim on both materials being biocompatible, maybe it works. Maybe not. But since it is a class I device, hence low risk, this could be possible.
In my opinion, a good justification goes a long way.
In my opinion, a good justification goes a long way.
