Article 61 - MDR Clinical Investigation Requirement

[Sammy23]

Hi,

I'd like to better understand the Clinical Investigation mandate under Art. 61. In my reading - I understand that equivalence to another manufacturers device is likely impossible. However, where a manufacturer claims equivalence to it's own devices (Class III) this is an acceptable path to go the clinical eval route.

We are developing a newer version of a device currently approved under 93/42/EEC. We intend to go under the MDR with this newer version - and believe we'd be able to prove equivalence from a biological, technical and clinical route. Conducting an animal study and biocomp testing.

For a new Class III device (not novel) - how does Art. 61 (a) apply? Is this saying that we can't go the clinical eval route since the new version of the device is not an MDD device?

Art. 61(a):
6. The requirement to perform clinical investigations pursuant to paragraph 4 shall not apply to implantable devices
and class III devices:
(a) which have been lawfully placed on the market or put into service in accordance with Directive 90/385/EEC or
Directive 93/42/EEC and for which the clinical evaluation:
— is based on sufficient clinical data, and
— is in compliance with the relevant product-specific CS for the clinical evaluation of that kind of device, where
such a CS is available


Any guidance would be helpful!!

 

[yodon]

Was hoping someone would jump in on this. Since nothing yet, I'll give it a go as best I can (with the caveat that this isn't an area I'm strong in).

First off, uncouple "clinical evaluation" from "clinical investigation." The former is the subject of the article and the latter is one method for getting clinical data. They're different things.

For an initial product launch, you may or may not be required to do a clinical study (investigation). It may be possible / acceptable to establish clinical evidence without a trial. Article 61.6(a) is saying that if you had a device cleared under the MDD and you have sufficient clinical data, you aren't required to conduct a clinical investigation.

Things seem to be pretty fluid these days. You'd best discuss your approach (early) with your NB and get their take on whether it's acceptable or not.

 

[QARAMar]

As you obviously have full access to the Technical Documentation to the previous version of your own device, and can justify equivalence using the criteria you specify, there should be no need for clinical investigation (trial).

As the previous poster points out, there is always the need for clinical evaluation which is not the same thing as clinical investigation. A clinical evaluation may or may not include a clinical investigation (trial).

 

[dgrainger]

You always have to perform a CE but can exclude a CI if:

• It's on the market under the directives - (6a) or
• It's in the list of exclusions (6b)
• It's a modification of a device already on the market (4)

Your NB will check.

Does your "newer version" qualify as a modification?

 

[Sammy23]

You always have to perform a CE but can exclude a CI if:

• It's on the market under the directives - (6a) or
• It's in the list of exclusions (6b)
• It's a modification of a device already on the market (4)

Your NB will check.

Does your "newer version" qualify as a modification?

You always have to perform a CE but can exclude a CI if:

• It's on the market under the directives - (6a) or
• It's in the list of exclusions (6b)
• It's a modification of a device already on the market (4)

Your NB will check'

Does your "newer version" qualify as a modification?

Thank you all for the helpful suggestions. The 'newer' version may qualify as a modification - I say may as the intended use will be the same, but will have an additional design feature allowing for an expanded intended use. The device is a guide wire, and CI for these devices are rare and do not seem to make much sense. We'd be forced to use our device as the equivalent device as the MDR is not allowing equivalence to another manufacturers device* (even though our modified device is most equivalent to another manufacturers device).

*Unless the other manufacturer would be me happy to agree to their competitor having access to their tech doc. Weird.

 

[Sammy23]

Was hoping someone would jump in on this. Since nothing yet, I'll give it a go as best I can (with the caveat that this isn't an area I'm strong in).

First off, uncouple "clinical evaluation" from "clinical investigation." The former is the subject of the article and the latter is one method for getting clinical data. They're different things.

For an initial product launch, you may or may not be required to do a clinical study (investigation). It may be possible / acceptable to establish clinical evidence without a trial. Article 61.6(a) is saying that if you had a device cleared under the MDD and you have sufficient clinical data, you aren't required to conduct a clinical investigation.

Things seem to be pretty fluid these days. You'd best discuss your approach (early) with your NB and get their take on whether it's acceptable or not.

Thanks so much for this clarification. If we are trying to get approval for a device (which is a modified version of a device approved under MDD), is the view that this modified version is not a device approved under MDD?