When you say Class 1 instrument, what do you mean?

Julie Omohundro I can only hope that others here will do you the kindness of explaining the wisdom of trying to DIY the regulatory side of developing and marketing a new medical device, since my own opinion on the subject is likely to lack credibility.

Mateusz Pawelec Both sides are right, briefly:
For devices in Class 1, clinical evaluation can be made on the basis of clinical trials OR clinical data.
Clinical evaluation on the basis of clinical data - It requires you (expert) to verify the literature data of similar product and expert’s opinion. However sometimes you have no data to compare so you should go through clinical trials.

“To get this instrument into the market”, here you have some earlier discussions:
https://www.linkedin.com/groups/78665/78665-6164116738096066565

Tejas Yarashi Hi Steve Roberts this instrument is a bone and plate holding clamp similar to the heygroves Orthopaedic surgeons use regularly. It's for transient use only normally less than 60 mins at a time in patients

Tejas Yarashi Thanks Mateusz Pawelec. That's very useful. My instrument is very similar to an instrument widely used in the world but with a novel design which solves a very important problem in bone and plate holding. It's a fundamental change with inherently the same use. I can't find any literature on the widely used instrument so would I be able to show that in terms of working parts it's not much different. Doing a clinical trial on my instrument seems to be an overkill for the type of product it is.
The biggest barrier atm seems to be this.

I guess it comes down to the company marketing it. Would anyone know a good instrument development company that would be keen to market a novel Orthopaedic device? I've already had surgeons telling me they would buy this for daily use but I'm stuck with the complexities of ?clinical trial or not and marketing. Would love some feedback. Thanks

Tejas, as others have alluded to there are some hurdles to overcome before you can launch a product for medical use in the UK market (or indeed any market). Without knowing the specifics of the product it very much depends on the application and the level of invasiveness (time and location) the product requires.

You mention that you are working with "an instrument development company who have CE marked it"? Can you elaborate on this as I am a bit confused by what this actually means. Is it a medical device manufacturer or an independent product development company? Who holds the technical file? You or the "instrument development company" or some 3rd party manufacturer?

If you want recommendations for UK based medical device manufacturers it depends on the speciality and materials. For example, for plastic products you could try the likes of http://www.splicecast.co.uk/

I would be very careful who you take advice from. Seek advice from your collegues and the nhd as it takes a team to succesfully bring a device to market. The best advice I can give is not to spend time looking at the detail of the medtech industry and regulation.

Ben Pattinson Surely the instrument development company that have made and ce marked the product would be interested in getting it tested for / with you ???

I don't know all the details and I'm not a Regulatory expert but if it has been already CE marked, technically it can be used right now on the market. To me or the company thinks the medical device has some associated risks and is asking an internal evaluation (not mandotary from a Regulatory point of view) or simply needs to understand if it's a good business for them! Instruments generally means investments/money and a company needs to be sure before to open its wallet!

Julie Omohundro Alessandro, that depends on what they mean by 'CE marked."

Yvanne Enever Did they self certify? If so the manufacturer will still need to register with Competent authority (MHRA) before they place on market. If you then want to gain clinical experience you can run a clinical investigation. We have recently set one up in London for a class 1 self certified IVD. If you want to drop me an email perhaps I can further advise when I know a little more? Yvanne.enever@pharmexcel.co.uk

Art Pichierri In that it is 'very similar' to what is being used today, perhaps you may fall under a grandfather clause whereby the CE is enough to allow introduction and/or purchase or licensor to an already established manufacturer whereby trials can ensue immediately using their regulatory arm for fast tracking.

Hi Tejas Yarashi, our company specialises in bringing orthopaedic medical devices to market in the UK. Please feel free to drop me an email at sarah@harbourmedical.co.uk so we can discuss in more detail.

Maurizio Colombo Hi. A clinical trial as part of the clinical evaluation is needed only if the evaluation of clinical literature on existing similar devices cannot give full assurance on the fulfillment of the Essential Requirements. From a Regulatory standpoint this will be fully enough to market the product as a class I device.
On the other hand, based on my company's experience (we distribute many types of devices in Italy), it may be that from a marketing and sales standpoint going to clinicians without any clinical trial on your device can make it difficult to actually convince the clinician that your product is better than the competitors. There seems to be a growing concern from clinicians on being reassured through a solid clinical background that the device is safe and effective (and overcomes the competitors).

Fabiano Lopes Abreu You have distributor in Brazil?

Dear
its a new instrument or there are other like it.
Do u have FDA

Nebrido Santiago By law, clinical evaluation is a pre-requisite for CE marking irrespective of the class of device. You should have some form of clinical evidence for safety & performance of the device prior to CE mark and registration to MHRA.
Clinical evaluation can be achieved in 3 ways either:
-literature route, -clinical experience, -clinical investigation (clinical trial is term commonly used for pharma) The last two are perform under controlled condition i.e. as per study protocol with appropriate methodologies and subjects.
I'm not surprise that the device has been "CE marked" without the requisite clinical evidence as this is not normally check by MHRA prior to registration unless through notified body.
If your device is not a novel or new technology, etc, then yes, clinical investigation may not be necessary since you can establish its safety & performance through other means e.g. literature route based from equivalence device.
Assuming its correctly CE marked and registered via self certification as Class 1 (not sterile), for all legal intent & purposes you can now market your instrument in UK.
The only step you need is with great marketing strategy to introduce it in NHS supply chain.

MHRA have a document specifically designed to offer guidance on custom made medical devices

You can talk to the Doctor who likes it, they must be having contacts with many orthopaedic companies. Hope this can help you

Dr. Santosh Thakur can you plz send me detail on aaditya.santosh@gmail.com

Robert Christensen Have a fun trip. Been there. Done that.

My understanding is that as long as it is not implanted the testing is less rigorous. We have two devices currently subcontracted for testing in China.

Send me more details. If you want a distributer in Egypt. Mostassan@gmail.com

Beluh Mabasa Ginting Clinical trail for instrument class 1 in Indonesia is not necessary due to they not hight risk and not need to be sterile when placed on the market. and in ASEAN region ) they are only listing (base on AMDD) and the most importance thing they mush comply to the Essential Requirement ( Essential principles of safety and performance of medical devices)