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MDR equvalent device - can you use a medicine as an equivalent 'device'

Ben S UK

Starting to get Involved
#1
Hi,

Wondered whether anyone had thoughts on if it is possible to use a medicine (or other non-medical device) as an equivalent product in terms of CEAR and clinical data under the MDR

Given that Rule 21 allows for substance based devices - some of which are currently regulated as medicines, despite having physical/mechanical modes of action - is it possible for a manufacturer that has access to the data (of a medicine) to use it as an equivalent product - assuming of course the equivalent principles can be met?

I've checked MDR text and section 3 of Annex XIV sets out the criteria for equivalent 'devices': scientific, biological, clinical; the MDCG guidance document on equivalence has a handy template for assessing equivalence. Neither or these seem to explicitly prohibit the use of a medicine as an equivlent product (from my reading) but they do consistently talk about equivalent devices.

It may be a question for the Notified Body but interested if anyone has any thoughts on this.

ben
 
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Ben S UK

Starting to get Involved
#3
I see the reference to devices throughout, but wondered whether this would be taken to prohibit non devices, assuming the criteria for equivalence are met (and the reference product also has a physical mode of action).

It may be a reasonably uncommon occurance generally speaking for devices, and hence why the MDR and guidance talks about device:device equivalence. But in relation to R21 there are number of current medicines which could be positioned as devices under MDR. Curious if data that exists for these products (obtained during medicinal development, and post marketing activities) could be used to support them or similar product as devices.

The CAs and NBs may have a different view, but personally i'd suggest that an equivalent product is an equivalent product (if all the relevant criteria are met), and the current classification is not relevant to the spirit of the regulation i.e. do you have data on a product that is substantially similar and can it be used to give confidence in the safety and performance of the new product.
 

dgrainger

Trusted Information Resource
#4
I would say that a medicine will, by definition, never be equivalent to a device as its mode of action is pharmacologic...
Rule 21 is a classification rule and not a qualification rule.
 

LukasLosigkeit

Starting to get Involved
#5
In order to claim equivalence under the MDR, you need to compare the following characteristics:

-technical
-clinical
-biological

The devices are not equivalent, because the materials that come into contact with the human body or fluids are not the same in a medical device and in a medicinal product.

How to claim equivalence was already established under MEDDEV 2.7-1 rev. 4 referring to the MDD.
The MDR is more rigorous when it comes to equivalence.
 

Ben S UK

Starting to get Involved
#6
Thanks both for the response.

Agree that typically medicines and devices have different MoA and are not equivalent.

I'm thinking of quite rare circumstances, whereby the medicine has a physical MoA and does not act PIM, but for historic reasons is a medicine and not a device. (Many markets have been relucatant to allow ingestible devices, especially many decades ago, and registered these products as medicines).

For example there are fibre based products for the treatment of constipation which are medicines in some EU markets - these typically act physically as a bulk forming agents with no PIM MoA. These could conceivably be registered as devices especially with a more prescriptive MDR in terms of ingestible substance based devices. In this instance using data already available from a medicine fibre-based product to demonstrate the clinical and safety performance seems rationale providing the equivalence criteria can be met.
 

LukasLosigkeit

Starting to get Involved
#7
Technical aspects:

The device is of similar design; is used under similar conditions of use; has similar specifications and properties including physicochemical properties such as intensity of energy, tensile strength, viscosity, surface characteristics, wavelength and software algorithms; uses similar deployment methods, where relevant; has similar principles of operation and critical performance requirements.

Equivalence is possible for technical aspects


Biological aspects:

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

The materials really need to be identical in order to be equivalent. The MDR is pretty strict in this part.
Where a manufacturer intends to claim equivalence to a device not manufactured by him, the MDR requires that the two manufacturers
have a contract in place that explicitly allows the manufacturer of the second device full access to the technical documentation on an ongoing basis.


Clinical aspects:

The device is used for the same clinical condition or purpose, including similar severity and stage of disease, at the same site in the body, in a similar population, including as regards age, anatomy and physiology; has the same kind of user; has similar relevant critical performance in view of the
expected clinical effect for a specific intended purpose.

Equivalence is possible for clinical aspects




I think the biological part will be the hardest.
And, of course, having access to the technical documentation.
Both makes it quite hard to claim equivalence under the MDR.
 

Raisin picker

Involved In Discussions
#8
Where a manufacturer intends to claim equivalence to a device not manufactured by him, the MDR requires that the two manufacturers have a contract in place that explicitly allows the manufacturer of the second device full access to the technical documentation on an ongoing basis.
That is actually only true for implantable devices and class III devices, where the manufacturer wants to introduce a new device on the market without a clinical trial (MDR Art. 61.5). Annex XIV (3) on equivalence only states
It shall be clearly demonstrated that manufacturers have sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify their claims of equivalence. This can (to my knowledge) be based on e.g., own lab analysis of the equivalent device.
 

LukasLosigkeit

Starting to get Involved
#9
That is actually only true for implantable devices and class III devices, where the manufacturer wants to introduce a new device on the market without a clinical trial (MDR Art. 61.5). Annex XIV (3) on equivalence only states
It shall be clearly demonstrated that manufacturers have sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify their claims of equivalence. This can (to my knowledge) be based on e.g., own lab analysis of the equivalent device.
Yes, you are right. The contract is only needed for class III. Thanks for clarification!
 
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