MDR Class Ir deadline (Reusable surgical instruments)

zeypzeyn

Starting to get Involved
#1
Hello to everyone

I am sure it was discussed before for hundred times but, i didn't know how to choose the keywords for this particular subject.

We have reusable surgical instruments such as forceps and scissors. Our products are self-declared as class I and is not subject to a NB. With MDR they are classified as Ir. The question is; when do we need to prepare a technical file and submit to the notified body. Normally, the date is May 2020 but it is postponed to 2024. Until 2024, will our products remain as self declared class I medical devices instead of class Ir.

I hope someone will answer
Thanks so much in advance.
 
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Raisin picker

Involved In Discussions
#2
Devices class Ir where you declared conformity prior to 2021-05-26 can be marketed until 2024.
But, you should start to prepare the technical files now. And submit to a NB sometime in 2022.

Art 120 (3):
By way of derogation from Article 5 of this Regulation, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2021 it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.
 

zeypzeyn

Starting to get Involved
#3
Thank you very much for your response.

To summerize what i understand from the article; our reusable products (which are going to be class IR according to MDR) can be sold as class I until 2024, only if they are certified before 2021 May according to MDD.(even it is self-decleration with no NB involvement). But we should start getting ready for 2024 deadline and submit to NB around 2022. Right?
 

Raisin picker

Involved In Discussions
#4
Right. You can declare conformity now to be safe until 2024, but be aware that you cannot introduce any changes that would trigger a new revision of the DoC after May 2021. And yes, start as soon as possible, especially if you don't have any experience with your NB (e.g. because you only have class I so far). I don't know how extensive the documentation for Ir needs to be, but I know that the regulations will be applied much more strictly than under MDD.
 

Raisin picker

Involved In Discussions
#6
2022 is just a recommendation on the safe side. But:
  • you don't know how easy you find a NB if you don't have one already
  • you don't know when your NB will find time to assess your documents
  • you don't know how long it will take you to address all nonconformities, you might even need to perform additional tests that take a few months
  • you do know that when you plan submission for mid 2022, you will be ready to submit by early 2023 ;-)
  • noone has any experience with submission for class Ir so far
  • (you need to have PMS/PMCF ready by May 2021 anyway)
You know, the main reason to create the MDR was that the NBs and competent authorities interpreted the MDD as gold standard that noone needs to fulfil completely, they have been very lenient. My personal experience is mainly in clinical evaluation. Most of the CERs I've seen so far have been somewhere in the lowest grey areas, but still have been accepted. It did not improve much with revision 4 of the MEDDEV 2.7/1. If you compare the MEDDEV 2.7/1 (forget about the MDD regarding CER), the MDR and the MDCG 2020-13, you see where it goes. I know a lot of devices certified under MDD that will have big problems when they submit for MDR.
I don't know the company zeypzeyn works for. But there are companies out there that currently have only class I devices, hence not much experience with NBs. They will struggle, especially if they don't have a competent RA expert (and those don't grow on trees).
 

zeypzeyn

Starting to get Involved
#7
Raisin picker you are more than right about how unexperienced we are with NBs as class I-only manufacturers.

Our biggest problem as you have mentioned is CER. Because our products are not novel devices. They have been used in surgeries for ages. So, we can not find a clinical research about a metzenbaum scissors! Any suggestion is appriciated about this simple devices.
 

Watchcat

Trusted Information Resource
#8
2022 is just a recommendation on the safe side.
Seems like good advice. I gave up following the EU after the EC caved on the deadline, so I was wondering if some sort of timeline had been announced. Based on the EC's initial failed effort, I would prioritize finding an NB above all else. Doesn't matter how complete your tech files are if you have no NB to review them.

Most of the CERs I've seen so far have been somewhere in the lowest grey areas, but still have been accepted. It did not improve much with revision 4 of the MEDDEV 2.7/1.
Yeah, that's been my experience, and I've never heard anything different from anyone who ever picked up a CER that hadn't been prepared by someone with a background in both RA and clinical or scientific writing. There was a measurable effort within industry to get more appropriate people to write them when they went to Rev 4, but there were also many, many companies that did not make this effort.[/QUOTE]

You know, the main reason to create the MDR was that the NBs and competent authorities interpreted the MDD as gold standard that noone needs to fulfil completely, they have been very lenient.
I don't know the main reason for the MDR.

- At first I thought it was because the NBs were not holding companies to the standard the EC had expected when it released the MDD, which I think left a lot of room for interpretation/wiggling/waffling. I thought of it as the EC saying to the NBs, "Read our lips, this is how you do it."

- Later I thought it might also have been an effort to give the NBs a solid foundation on which to stand. They are profit-making enterprises. They are unlikely to hold a customer's feet to the fire unless a requirement is very, very clear, because that will just cost them business, when there will be other NBs interpreting the same requirement more to a manufacturer's liking. So, still the EC saying "Read our lips," but to the companies as much or more as to the NBs.

- Finally, watching how it played out on the first try, I wondered if it wasn't mostly an effort by some of the NBs to eliminate competition, meaning they were really the power behind it, not the EC. That would be a very viable hypothesis in the US, only it would be the bigger device companies trying to eliminate competition by getting FDA to raise the bar. I don't know much about EU politics, though.

In any case, whatever the motive, I and others hoped it would wash out a good number of the companies and devices that should never have been on the market in the first place. Could be they will apply the MDR more strictly than the MDD, but the EC caving on the deadline did not strike me as a promising sign.
 

Raisin picker

Involved In Discussions
#9
Could be they will apply the MDR more strictly than the MDD, but the EC caving on the deadline did not strike me as a promising sign.
I still hope that. The change of deadline is, of course, not because of COVID-19, but because of the low number of NB available. To date, there are 15 NB accredited for MDR of about 45 who have applied, and of about 60 that did or still do MDD. I do believe that in May 2021, not all NB who applied for MDR will be accredited. Similar picture for IVDs.
About your other ideas, I'm not long enough in the market to understand those mechanices and politics. But, some of the lead persons on the NB side just left their jobs and switched to consultation, so that does not further your third idea.
 

zeypzeyn

Starting to get Involved
#10
Raisin picker and Watchcat do you have any advice on manufacturers who struggle with CER. Because our products are not novel devices. They have been used in surgeries for a long time. So, we can not find a clinical research about them.
 
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