First CE-mark class III implantable device under MDD

#1
Hi community!I'd like to share my troubles of the last week and see if you could help me understand whether I am missing sth.

We got this client, they got a class III implantable device that will be launched in the next weeks under MDD.

Here comes my first problem: they are trying to get a CE mark based on equivalence with three of their own, already-marketed devices. Once they do so, they want to automatically start their transition to MDR.

My questions are:
1. is it possible to get a new CE mark under MDD for a class III implantable device right now?
2. their already-marketed devices do not have any clinical data. Don't ask me how they got their CE mark. I don't know. Do you think it is possible to claim equivalence and get a CE mark if the equivalent device has no clinical data of its own?
3. the manufacturer claims they will will conduct a 5-year prospective PMCF study to obtain data on the long-term safety of their device for MDR. Is it possible to get a class III implantable device on the market without clinical data acquired before the CE-marking?

I think I am either missing sth here with respect to regulations or this client risks of not getting this product in the market.
thank you all for your thoughts!
Aaron
 
Elsmar Forum Sponsor

dgrainger

Trusted Information Resource
#2
I don't think it is possible without clinical data:

"ANNEX X 1.1a In the case of implantable devices and devices in Class III clinical investigations shall be performed unless it is duly justified to rely on existing clinical data."​
 
#3
I don't think it is possible without clinical data:

"ANNEX X 1.1a In the case of implantable devices and devices in Class III clinical investigations shall be performed unless it is duly justified to rely on existing clinical data."​
Hi, thks for your reply but I am not sure where your quote comes from; I cannot find it in either MDD or MDR. Can you pls confirm?
Plus, this manufacturer is aiming to CE-mark under MDR according to Chpt VI, Art. 61, point 4, i.e.

In the case of implantable devices and class III devices, clinical investigations shall be performed, except if:
—the device has been designed by modifications of a device already marketed by the same manufacturer,


So my question is:
how is this compatible with the general understanding that there are no grandfathering provisions for MDR and
will it be enough to use this rationale when the already marketed device got their CE mark with clinical data coming from literature?

Thks community.! All thoughts highly appreciated!
 

dgrainger

Trusted Information Resource
#4
Hi, it's from MDD, Annex X - clinical evaluation.

Your extract from MDR Article 61 has to be taken in full:

"4. In the case of implantable devices and class III devices, clinical investigations shall be performed, except if:
— the device has been designed by modifications of a device already marketed by the same manufacturer,
— the modified device has been demonstrated by the manufacturer to be equivalent to the marketed device, in accordance with Section 3 of Annex XIV and this demonstration has been endorsed by the notified body, and
— the clinical evaluation of the marketed device is sufficient to demonstrate conformity of the modified device with the relevant safety and performance requirements.
In this case, the notified body shall check that the PMCF plan is appropriate and includes post market studies to demonstrate the safety and performance of the device.
In addition, clinical investigations need not be performed in the cases referred to in paragraph 6"

Any demonstration will need to be endorsed by the NB.
 
#5
Hi Aaron,

1. is it possible to get a new CE mark under MDD for a class III implantable device right now?
It is possible, but it is probably quite difficult to get a Notified Body willing to do so at the moment.

2. their already-marketed devices do not have any clinical data. Don't ask me how they got their CE mark. I don't know. Do you think it is possible to claim equivalence and get a CE mark if the equivalent device has no clinical data of its own?
It shouldn't happen, but I've seen cases in which class III devices have no clinical data at all. Again, this seems to be largely dependent on the Notified Body performing the assessment. Since their other devices have a CE mark, I see how they can possibly hinge their safety and performance claims on post-market data at this stage. They can then justify and demonstrate equivalence to those previous devices. They are probably proving equivalence to certain characteristics of their previous devices. It's really messy and kind of 'frankensteining' the process, but personally have seen this work, especially if the devices are quite similar. This should only really work for relatively simple devices. The technical documentation should provide sufficient justification as to why clinical data was not provided, based on risk management, safety features, pre-clinical testing.

3. the manufacturer claims they will will conduct a 5-year prospective PMCF study to obtain data on the long-term safety of their device for MDR. Is it possible to get a class III implantable device on the market without clinical data acquired before the CE-marking?
This should not be possible under MDR. Technically, if they obtain a CE mark under the MDD they will have time to collect useful clinical data from the market, especially if they are going to conduct prospective high-quality PMCF studies. This could potentially be successfully used as clinical data for an MDR certification. But this will always depend on the Notified Body concerned.

Hope this helps!
Ken
 
#6
Hi, it's from MDD, Annex X - clinical evaluation.

Your extract from MDR Article 61 has to be taken in full:

"4. In the case of implantable devices and class III devices, clinical investigations shall be performed, except if:
— the device has been designed by modifications of a device already marketed by the same manufacturer,
— the modified device has been demonstrated by the manufacturer to be equivalent to the marketed device, in accordance with Section 3 of Annex XIV and this demonstration has been endorsed by the notified body, and
— the clinical evaluation of the marketed device is sufficient to demonstrate conformity of the modified device with the relevant safety and performance requirements.
In this case, the notified body shall check that the PMCF plan is appropriate and includes post market studies to demonstrate the safety and performance of the device.
In addition, clinical investigations need not be performed in the cases referred to in paragraph 6"

Any demonstration will need to be endorsed by the NB.
OK thks, now I get it. So you are saying all three bullets must be met at the same time? I did not realize that; I Was reading this all wrong.
 
#7
Hi Aaron,

1. is it possible to get a new CE mark under MDD for a class III implantable device right now?
It is possible, but it is probably quite difficult to get a Notified Body willing to do so at the moment.

2. their already-marketed devices do not have any clinical data. Don't ask me how they got their CE mark. I don't know. Do you think it is possible to claim equivalence and get a CE mark if the equivalent device has no clinical data of its own?
It shouldn't happen, but I've seen cases in which class III devices have no clinical data at all. Again, this seems to be largely dependent on the Notified Body performing the assessment. Since their other devices have a CE mark, I see how they can possibly hinge their safety and performance claims on post-market data at this stage. They can then justify and demonstrate equivalence to those previous devices. They are probably proving equivalence to certain characteristics of their previous devices. It's really messy and kind of 'frankensteining' the process, but personally have seen this work, especially if the devices are quite similar. This should only really work for relatively simple devices. The technical documentation should provide sufficient justification as to why clinical data was not provided, based on risk management, safety features, pre-clinical testing.

3. the manufacturer claims they will will conduct a 5-year prospective PMCF study to obtain data on the long-term safety of their device for MDR. Is it possible to get a class III implantable device on the market without clinical data acquired before the CE-marking?
This should not be possible under MDR. Technically, if they obtain a CE mark under the MDD they will have time to collect useful clinical data from the market, especially if they are going to conduct prospective high-quality PMCF studies. This could potentially be successfully used as clinical data for an MDR certification. But this will always depend on the Notified Body concerned.

Hope this helps!
Ken
Ken very generous of you to provide such a detailed answer. I really appreciate it!!
It is the Notified Body's reaction that worries me most and triggers all my questions. Because even if they manage they get into the market by acquiring a CE-Mark under MDD now, I am not sure how we'd help them make the transition to MDR right afterwards.
Since this is a class III implantable, there will be a clinical evaluation consultation. And the no-grandfathering provision will have them revising the MDD contents.
Plus, I am not sure how much (and of what quality) prospective data they can collect since they will have less than 6 months to collect them: they estimate to get MDD certification in December and they have to switch to MDR by May. Which is why I see an actual risk of not making it. Would you advice them to claim equivalence for MDR too?
Thks once again Ken!
 
#8
Hi Aaron,
My pleasure!
If they successfully obtain their CE mark under the MDD, they will have until the end of the validity period on their CE certificate to place the device on the market, albeit under the MDD. There are a few terms and conditions laid out for this in Article 120(3) of the MDR.

Relevant clinical data collected throughout the post-market phase should definitely be used in future applications, as it still the same device.

Best wishes,
Ken
 
Thread starter Similar threads Forum Replies Date
W CE Mark for Class III Medical Device - MDR or MDD applies? CE Marking (Conformité Européene) / CB Scheme 10
V Class III Device CE Mark with ISO 9001 Registration? EU Medical Device Regulations 4
R Class III Medical Device with CE Mark - UK Registration Process EU Medical Device Regulations 6
C Design requirements - CE Mark / Class III device / Annex II.3 + Annex II.4 EU Medical Device Regulations 4
J Class III Medical Device with CE Mark Approval - India Registration Process ISO 13485:2016 - Medical Device Quality Management Systems 10
R IVDR CE Mark for Class A products - Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
S Until when can we CE-mark and sell MDD class 1 devices? CE Marking (Conformité Européene) / CB Scheme 17
N CE Mark for Class 1 medical device CE Marking (Conformité Européene) / CB Scheme 11
E EU Class 1s CE Mark Regulatory Pathway EU Medical Device Regulations 9
L Class IIa Medical Device, CE Mark & 510k - Labeling Content CE Marking (Conformité Européene) / CB Scheme 4
D US Made class I CE Mark product for export only to EU Other US Medical Device Regulations 4
M ISO 13485 Required for CE Mark on Class I product CE Marking (Conformité Européene) / CB Scheme 1
C Class I Reusable Surgical Instruments - CE Mark with the Notified Body number EU Medical Device Regulations 14
A ROHS and CE Mark - Requirements for a Class IIa Medical Device EU Medical Device Regulations 6
E Medical Device Class 2a CE Mark Clinical Evaluation Report CE Marking (Conformité Européene) / CB Scheme 3
K Class Ins CE Mark Labeling Requirements (particularly Lot or Batch symbol and number) EU Medical Device Regulations 7
A Design Company - CE Mark for a Medical Device Class 2A , Annex VI & Annex VII EU Medical Device Regulations 12
G Selling a CE mark Class I Medical Device in Sweden - Any other requirements? EU Medical Device Regulations 13
J Question about CE mark for Dental Gel which is probably Medical Device Class 2a EU Medical Device Regulations 2
D CE Mark Labeling Requirements for a Class II Medical Device EU Medical Device Regulations 3
A Launching a CE Mark Class I (non-measuring and non-sterilzed) Medical Device EU Medical Device Regulations 1
K Multi site Clinical Investigation For CE Mark Application - Class IIa Device (UK) CE Marking (Conformité Européene) / CB Scheme 3
E How to get FDA Approval for Class II Medical Device - We have CE Mark, 13485, 9001 US Food and Drug Administration (FDA) 12
L Where to CE Mark a Class I medical device the size of a small tablet EU Medical Device Regulations 1
N Class 2a Medical Device (Nebulizer) - What is best route to getting CE mark? ISO 13485:2016 - Medical Device Quality Management Systems 5
M CE Mark Size Requirement - Class I Medical Device EU Medical Device Regulations 8
O CE Mark requirements for Class IIA MDs - European medical devices importers EU Medical Device Regulations 6
Sidney Vianna Dubai to Have Its Own World Class Quality Mark Customer and Company Specific Requirements 3
L CE Mark - FDA - Class I traction systems - What is involved and how long does it take EU Medical Device Regulations 5
F List of countries that 'prefer' a CE Mark CE Marking (Conformité Européene) / CB Scheme 1
C Surgical mask stability testing (CE mark) EU Medical Device Regulations 1
M MDR EU Distributor for our CE Mark product in the for Netherlands EU Medical Device Regulations 6
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
Ed Panek CE Mark Requirements on Kits (off the shelf product requirements met) CE Marking (Conformité Européene) / CB Scheme 2
G UVC sterilizer CE Mark CE Marking (Conformité Européene) / CB Scheme 4
C Does a CE mark infer meeting all applicable standards? CE Marking (Conformité Européene) / CB Scheme 4
M CE Mark and 510(k) -Global registration requirements for every country Other Medical Device Regulations World-Wide 3
A CE Mark and PMCF study EU Medical Device Regulations 3
T CE mark start date for a device EU Medical Device Regulations 7
P API monogram mark requirements Oil and Gas Industry Standards and Regulations 1
S CE Mark - Classification Confusion EU Medical Device Regulations 12
Y CE Mark - Placing the CE mark on medical device labels EU Medical Device Regulations 2
B Need For BIS Standard Mark? Imported OEM's Power supply,Li-Ion Battery Other Medical Device Regulations World-Wide 0
D Vietnam requirement of CE mark for medical devices CE Marking (Conformité Européene) / CB Scheme 4
A CE mark - Measuring Instruments Directive confusion! CE Marking (Conformité Européene) / CB Scheme 0
S CE mark on a medical device - Textile product CE Marking (Conformité Européene) / CB Scheme 2
V CE Mark under MDD or IVDR - IVD company doing Virtual Manufacturing Other Medical Device Regulations World-Wide 3
S REF and CE mark symbols on multi-component device EU Medical Device Regulations 3
D Who are the accredited Certified Bodies for CE Mark for Medical Devices? CE Marking (Conformité Européene) / CB Scheme 7
Ed Panek GTIN (Global Trade Item Number) for non CE Mark Other Medical Device Related Standards 4

Similar threads

Top Bottom