I know this is basic but this can change all your strategy. I saw some companies trying to put a product on the market that in reality is not a medical device. And on the other side, I saw companies wanting to place on the market a drug as a Medical Device. All this because they didn't understand the Medical Device definition.
In US, FDA has a Drug Device Combination product category. If the primary mode of action (PMOA) is drug, then "drugs - pharmaceutical" regulations are applied, and if the PMOA is device, then "device" regulations have to be followed .
The "Day 3 of the Mini-Course MDR 2017/745" brings me here. Like other Monir's videos that I've watched, this one helped me a lot to get an overview of the medical devices, in a simple way to understand, and easy to remember . Great job! Thank you, Monir.
Great video breaking the MDR down into layman's terms making it easier to understand. The test questions also make you think and be able to understand the logic behind the MDR. Well done.
Thanks very much! Very interesting! Have a question, as definition in EUMDR "medical device" for "human use", it means not for "animal use", so we have any regulations for devices for "animal use"?
I know someone who has placed medical devices on the market since 1998, all these devices performed medical the 1st devices were manufactured and sold from 1998 onwards, the second devices from 2000 onward and the devices now from 2002 to now, I would assume the devices from 2002 would have been or should have been CE marked/CE medical, but what about devices prior to EU law on compliance, can you still have devices that perform medical without certification because it was manufactured prior to EU regulations, Thanks for the last question answered and if you can answer this i would be grateful
Hi Ian, depends which regulation, but a medical device placed on the market before the regulation was existing, is then acceptable. But as soon as the regulation is in place any unit of this device should comply with the new regulation. The MDD 93/42/EC was published in 1993 and applied in 1996 after a transition period. So if your device is falling within this one this is still in the scope of the directive. But if your device which was placed on the market prior the regulation was issued, create some health problems, then the competent authority can stop its commercialization.
Competent authority by that you mean Trading Standards what i have seen in regards to trading standards especially when it come to CE compliance they are useless , one trading standards removed a illegal IPL which performed medical treatments, then unable to validate the certificate then placed the illegal device back in the salon. How our Trading standards had the job of policing CE compliance is beyond me, thanks for the reply " fancy a job in the UK has market surveillance" you cant do worse.
I was told to contact market surveillance i.e. trading standards,. So if it's a device like IPL that can perform medical treatments it's MHRA I contact. What ifba devices ihas no CE compliance but does not perform medical is that still MHRA or then is it trading standards, or HSE Thanks in advance
If someone imports a device they remove the logo and place their own logo on that device are they now responsible for that device and that all CE certification is in order, the original device was imported from S Korea into the UK
Hi Ian, if a product package has been changed which misleads the brand, the manufacturer name,... then this entity will be the new manufacturer and should CE mark the product. They should have a Technical File and all that is required from the original manufacturer.
The answer for the syringe is not NO, but YES - it is a Medical Device, because it's first intend action is to go through the skin, and after that to release the drug. So you'll have to Classify it for sure.
@@olechkata You are half right. You have to defined the intended use of a pre-filled syringe which is the action of the drug. The syringe is a medium to reach this objective. So the first regulation to apply is the Drug one. But with Article 117 of the MDR you still have to request an assessment by a notified body for the medical device part. Some reading for explaining that www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu/745-eu-2017/746_en.pdf
@@gunanithi4478 As said on the answer to Olechkata, the primary mode of action for a pre-filled syringe is not the syringe but the drug that is inside. The syringe is just the medium to deliver the drug. So this should be regulated by the Medicinal Directive. On the MDR 2017/745, article 117 is now amending the Regulation. It ask to have a Notified Body assessment for the Medical Device that is included in the combination product. More information are available on this link below: www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu/745-eu-2017/746_en.pdf
I know this is basic but this can change all your strategy. I saw some companies trying to put a product on the market that in reality is not a medical device. And on the other side, I saw companies wanting to place on the market a drug as a Medical Device. All this because they didn't understand the Medical Device definition.
In US, FDA has a Drug Device Combination product category. If the primary mode of action (PMOA) is drug, then "drugs - pharmaceutical" regulations are applied, and if the PMOA is device, then "device" regulations have to be followed .
The "Day 3 of the Mini-Course MDR 2017/745" brings me here. Like other Monir's videos that I've watched, this one helped me a lot to get an overview of the medical devices, in a simple way to understand, and easy to remember . Great job! Thank you, Monir.
You're the Man! Your explanations are very comprehensive and simple. I'm gonna go through the videos list. Your work is very much appreciated.
You have put it in really simple terms where everybody can understand. It's really helpful. Thanks for giving out these information for free.
Great video breaking the MDR down into layman's terms making it easier to understand. The test questions also make you think and be able to understand the logic behind the MDR. Well done.
Thanks Nigel, really appreciated
Thanks very much! Very interesting! Have a question, as definition in EUMDR "medical device" for "human use", it means not for "animal use", so we have any regulations for devices for "animal use"?
Hi Nga, in the EU, each countries has its own legislation. But this is not really well regulated.
@@EasyMedicalDevice thanks so much!
I know someone who has placed medical devices on the market since 1998, all these devices performed medical the 1st devices were manufactured and sold from 1998 onwards, the second devices from 2000 onward and the devices now from 2002 to now,
I would assume the devices from 2002 would have been or should have been CE marked/CE medical, but what about devices prior to EU law on compliance, can you still have devices that perform medical without certification because it was manufactured prior to EU regulations,
Thanks for the last question answered and if you can answer this i would be grateful
Hi Ian, depends which regulation, but a medical device placed on the market before the regulation was existing, is then acceptable. But as soon as the regulation is in place any unit of this device should comply with the new regulation.
The MDD 93/42/EC was published in 1993 and applied in 1996 after a transition period. So if your device is falling within this one this is still in the scope of the directive.
But if your device which was placed on the market prior the regulation was issued, create some health problems, then the competent authority can stop its commercialization.
@@EasyMedicalDevice How
Competent authority by that you mean Trading Standards what i have seen in regards to trading standards especially when it come to CE compliance they are useless , one trading standards removed a illegal IPL which performed medical treatments, then unable to validate the certificate then placed the illegal device back in the salon.
How our Trading standards had the job of policing CE compliance is beyond me, thanks for the reply " fancy a job in the UK has market surveillance" you cant do worse.
No a competent authority is MHRA for the UK or ANSM for France, SwissMedic for Switzerland... each member of the EU is a competent authority
I was told to contact market surveillance i.e. trading standards,.
So if it's a device like IPL that can perform medical treatments it's MHRA I contact.
What ifba devices ihas no CE compliance but does not perform medical is that still MHRA or then is it trading standards, or HSE
Thanks in advance
More content please I am working on my orthopedic medical device however I am struggling to get a USPTO Patent due to lack of funds
Do I need to register PRRC? Where to register PRRC? Thank you very much!
Yes you have to register your PRRC within your quality management system and also in EUDAMED. A Notified Body will check that
Hair trimmer is a medical device or not ?
Thank you Monir
If someone imports a device they remove the logo and place their own logo on that device are they now responsible for that device and that all CE certification is in order, the original device was imported from S Korea into the UK
Hi Ian, if a product package has been changed which misleads the brand, the manufacturer name,... then this entity will be the new manufacturer and should CE mark the product. They should have a Technical File and all that is required from the original manufacturer.
Excellent information. Nice presentation!!!
Thanks Monir! thanks for the condensation!
You‘re welcome.
Looking forward to your upcoming vids. Keep it up!
Very Nice Video and good Monir's définition of medical device
Thanks, appreciated
Yes pity i had not seen this i would have sent it to our useless trading standards, very good and informative
Thank you, very very interesting.
The answer for the syringe is not NO, but YES - it is a Medical Device, because it's first intend action is to go through the skin, and after that to release the drug. So you'll have to Classify it for sure.
But the Drug is a Drug. So, at the end you have both certificats to produce this drug
@@olechkata You are half right. You have to defined the intended use of a pre-filled syringe which is the action of the drug. The syringe is a medium to reach this objective.
So the first regulation to apply is the Drug one.
But with Article 117 of the MDR you still have to request an assessment by a notified body for the medical device part.
Some reading for explaining that www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu/745-eu-2017/746_en.pdf
@@EasyMedicalDevice Thanx!
Whether answer is yes or no, could you elaborate pls.
@@gunanithi4478 As said on the answer to Olechkata, the primary mode of action for a pre-filled syringe is not the syringe but the drug that is inside. The syringe is just the medium to deliver the drug. So this should be regulated by the Medicinal Directive.
On the MDR 2017/745, article 117 is now amending the Regulation. It ask to have a Notified Body assessment for the Medical Device that is included in the combination product.
More information are available on this link below:
www.ema.europa.eu/en/documents/regulatory-procedural-guideline/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu/745-eu-2017/746_en.pdf
Thanks!
You’re welcome fabio
Interesting 👌👌
Let me know if you have some questions. Thanks for your thumb up. Cheers.
Good video
Thanks for your comment appreciated
👍👍👍 very good