Class I Reusable Surgical Instruments - CE Mark with the Notified Body number

Chrisx · Jun 21, 2016

The latest draft of the MDR has the aspects of reuse of reusable surgical instruments subject to conformity assessment by the notified bodies. I think this means that the devices would have to bear the CE with the notified body number. Do we think this will apply to product already placed on the market? If not, I have a lot of laser marking to do, ugh. For sure it will be a discussion point with our notified body, but its too early for them to have reached a decision.

ChrisX

Ronen E · Jun 21, 2016

Chrisx said:
The latest draft of the MDR has the aspects of reuse of reusable surgical instruments subject to conformity assessment by the notified bodies. I think this means that the devices would have to bear the CE with the notified body number. Do we think this will apply to product already placed on the market? If not, I have a lot of laser marking to do, ugh. For sure it will be a discussion point with our notified body, but its too early for them to have reached a decision.

ChrisX

Considering the general EU approach to grandfathering, I think that after any applicable transition periods, everything in the MDR will apply to product models already on the market, unless a specific exemption is spelled out.

If you were referring to device units already on the market, I think that they will continue to be able to be used without a change, however for being resold (= "made available on the market") they will have to be compliant.

Chrisx · Jun 22, 2016

Yes, I think this will be the interpretation as well. For the orthopedic industry, remarking all reusable instruments with the notified body number is a big task. I think many won't do it willingly.

RobertvanBoxtel · Jun 22, 2016

I do not see that following Annex VIII for reusables will result in a CE mark with NB number. Can you show your reasoning?

And: the CE mark is only a small issue, because:

Annex V:
4.10 Devices that are reusable shall bear a UDI Carrier on the device itself. The UDI Carrier of reusable devices that require cleaning, disinfection, sterilisation or refurbishing between patient uses shall be permanent and readable after each process performed to make the device ready for the next use for the intended lifetime of the device. The requirement of this
section shall not apply to any device that meets any of the following criteria:
(a) Any type of direct marking would interfere with the safety or performance of the device;
(b) The device cannot be directly marked because it is not technologically feasible.

This might be more challenging....

Chrisx · Jun 22, 2016

I'm not sure if the new MDR requires the number. Article 18 states:

"Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 42. "

I think under the current MDD 93/42/EEC, class I sterile and class I measuring required the notified body number, but I might be wrong.

You are correct that the direct marking of the UDI poses another issue. I'm hoping they will not require it for consigned inventory, just like FDA has indicated in a newsletter to AdvaMed.

pkost · Jun 23, 2016

Chrisx said:
I'm not sure if the new MDR requires the number. Article 18 states:

"Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in Article 42. "

I think under the current MDD 93/42/EEC, class I sterile and class I measuring required the notified body number, but I might be wrong.

You are correct that the direct marking of the UDI poses another issue. I'm hoping they will not require it for consigned inventory, just like FDA has indicated in a newsletter to AdvaMed.

It is article 42(5) (Conformity assessment procedures) that requires this and has appeared as a result of th trilogue discussions:

Manufacturers of devices classified as class I, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 17 after drawing up the technical documentation set out in Annex II. If the devices are placed on the market in sterile condition, are reusable surgical instruments or have a measuring function, the manufacturer shall apply the procedures set out in Annex VIII, Chapter I (Quality Management System) and Chapter III (Administrative provisions), or in Part A of Annex X. However, the involvement of the notified body shall be limited:
(a) in the case of devices placed on the market in sterile condition, to the aspects concerned with establishing, securing and maintaining sterile conditions,
(b) in the case of devices with a measuring function, to the aspects concerned with the conformity of the devices with the metrological requirements;
(c) in the case of reusable surgical instruments, to the aspects related to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use.

RobertvanBoxtel · Jun 23, 2016

Yes, I follow your line of thought and saw that in Article 42. But, it does not say that for the reusable situation (c), the NB number shall be added to the CE mark. Maybe the final text will be more conclusive on that.

nozzle · Sep 11, 2018

Hi,
If I'm reading the final text of the MDR correctly then reusable class 1 surgical instruments will have the cleaning, disinfection etc.. processes come under the scrutiny of the notified body and will need to apply the notified body number, in accordance with Article 52, 7c.

Have I understood this correctly?
TIA

Marcelo · Sep 11, 2018

nozzle said:
Hi,
If I'm reading the final text of the MDR correctly then reusable class 1 surgical instruments will have the cleaning, disinfection etc.. processes come under the scrutiny of the notified body and will need to apply the notified body number, in accordance with Article 52, 7c.

Have I understood this correctly?
TIA

Yes. Anytime a NB is involved in the conformity assessment procedure (classes IIa, IIb, III and the sterilization/measurement/reusable surgical instruments of class I), their number needs to be part of the label.

RobertvanBoxtel · Sep 11, 2018

That is correct. To be able to undergo the "Scrutiny" of the Notified Body, the described options for the conformity assessment procedure will have to be followed.

Class I Reusable Surgical Instruments - CE Mark with the Notified Body number

Chrisx

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Ronen E

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Chrisx

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RobertvanBoxtel

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Chrisx

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