Drug Device Submission: Is a Technical File required

H

Hrobot

#1
Hi,
I have moved on from a medical device environment to a autoinjector drug device environment which relates to drug submission rather than 510(k). This device falls under the medicinal drug directive.
My question is regarding
-if hazard analysis (identify hazard, clasification, risk control measures) is required at all,
- declaration of conformity is needed for EU,
- a separate technical file is needed for EU. (Conformance to Essential requriements is needed but does this have to sit in a technical file or can it sit in the submission document.

Thanks in advance for your input.
hrobot
 
Elsmar Forum Sponsor

bio_subbu

Super Moderator
#2
Hi Hrobot

I request you to verify your product Autoinjector is defined as a Medical Device if it complies with the definition of a Medical Device under the Medical Devices Directive (MDD) 93/42/EEC Article 1 Clause 2a.

“Medical Device: any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of

— diagnosis, prevention, monitoring, treatment, or alleviation of disease,

— diagnosis, monitoring, treatment, alleviation of, or compensation for an injury,
— investigation, replacement, modification, or support of the anatomy or of a physiological process,

— supporting or sustaining life,

— control of conception,

— disinfection of medical devices,

— providing information for medical purposes by means of in vitro examination of specimens derived from the human body, and which does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its function by such means”
.

Therefore in order to be classified a medical device, a product must be intended to provide or assist with the diagnosis, monitoring, prevention or treatment of a medical condition. My guess is, your product Auto-injector /pen injector is a medical device. You need to have CE technical file and should have hazard analysis details, classification route, declaration of conformity and other information with respect to your product. You may want to submit the technical file to your notified body as a submission document.

For classification details, I would suggest you to refer MEDDEV 2.4/1 Rev 09- Classification of medical devices.

Regards
S. Subramaniam
 
H

Hrobot

#3
Hi,

In this case the device is a drug delivery device which is single use where the device part is the ancillary function. Therefore the applicable directive is the medicinal product directive. However the manufacturer still needs to prove that the device is designed based on the essential requirements of the MDD. The question is if this can be a standalone document or this needs to sit under a Technical File as it is for a medical device.

Thanks in advanced for the opinion.
 
D

depa1978

#4
Hi everyone,


I re-open this discussion as it seems exactly the correct topic for my question:my client means to introduce on the European Market a drug and a device encapsulated together in a single product for single administration.
There isn't any interactions between them, and they are both registered as for what concern respective regulations. The device is going to monitor compliance and other physiological parameters of the patient.

The only thing is that now they are going to be administered together.
I am going mad trying to understand the correct regulatory strategy :bonk:
Anyone who already had similar experiences?
Thanks!!
Giovanni
 

chris1price

Trusted Information Resource
#5
Hi

The first decision is whether the "device" falls under the MDD or not. If when sold the drug is combined with the device (eg prefilled syringe or inhaler), the whole product is classed as a drug and falls under the drug regulations. If the device is separate and can be reused (eg an empty syringe) then that part is a device and falls under the MDD. Take a look at Article 1, Para 3 of the MDD, there are also several EU and MHRA guidance documents that give more examples.

If the whole product falls under the drug regulations, then I believe you need the CTD files under ICH Quality Module 3. However that is now a whole different area.

Note, the requirements of Article 117 of the new MDR may make the process very different in future. I would start talking to a Notified Body now.

Chris
 
D

depa1978

#6
Hi Chris, thanks.
In this case, the device is already registered as IIa device, and used (through ingestion) for monitoring of patient parameters.The drug has been registered many years ago.



Together in the same capsule there isn't any interaction (already tested) but the company would like to create this "kit" (maybe we couldn't define it a combination product) also to monitor the compliance related to the drug.


I know the new MDR will change the process, but I am a bit confused regarding the correct route as per the current MDD. Maybe anything to do?
 

chris1price

Trusted Information Resource
#7
Hi, without knowing more detail, it is difficult to answer. My suggestion would be to contact your Notified Body for assistance.
 
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