Clinical Requirements for HO (Human Organ) Medical Devices

Chrisx

Involved In Discussions
#1
I work for a company that makes human cell tissue products from non-viable human tissue. Primarily it is human bone allograft for the spine market and achilles tendons. They were considering entering the EU market, but now the new MDR would appear to require a clinical investigation. I think they have largely abandoned the project. I'm curious how many people think this segment of the industry will have the necessary clinical investigations to support CE marking? Is my company unique or is this fairly typical of the tissue banking industry? I suspect in the end some extension will have to be made to allow the continued marketing of the products, as the necessary clinical investigations will not have been completed. On the other hand, those that complete the work have the potential to capture significant market share.
 
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QA-Man

Involved In Discussions
#2
Re: Clinical requirements for HO devices

I don't think the new requirements have gone into effect yet. A literature review may suffice in this instance.
 

L_O_B

Involved In Discussions
#3
Re: Clinical requirements for HO devices

If you take a look into the final provisions (chapter X) and then the transitional provisions (Article 94) section 7 there it is said that products like yours, defined in article 1(2) point (e) and (ea), that has been placed on the market or put into service before application of the regulation, may continue to be placed on the market and put into service.

But still the regulation is just a proposal and may be changed or even completely discarded. It has not been published in the official journal of the European Union and thus it has neither entered into force nor does it apply.
Even if the current version of the MDR would be published tomorrow (which I do not expect) you could still let your product be certified in the next 3 years and 20 days without application of the new rules.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Re: Clinical requirements for HO devices

But still the regulation is just a proposal and may be changed or even completely discarded.
Hello L_O_B and welcome to posting on the Cove :bigwave:

The MDR is quite likely to come into effect in late 2016 / early 2017. True, it may still change but substantial changes (i.e. other than linguistic / technically-legal) are not expected at this stage. I find it quite improbable that it will be discarded altogether, even though it is possible.
 

pkost

Trusted Information Resource
#5
You may want to look at whether your product is actually a medical device - I have previously worked with non viable human tissue products and they were not covered under the medical device directive (I don't think the new regulation has changed to include them). As such they are no CE marked and do not have to comply

You may however want to look at the Tissues and Cells Directives
 

L_O_B

Involved In Discussions
#6
Re: Clinical requirements for HO devices

Hello Ronen and thanks for the welcome,

you are right. I was not clear in explaining the likeliehood of my statement. I also expect the MDR to enter into force in the beginning of 2017 and just wanted to say that there are still other possible outcomes. And I do not think that the current version will be published in the official journal, because there are a lot of missleading wordings already in the English version. The German version is a catastrophy on all its 353 pages as the German delegation already pointed out. Also the French, Italian, Polish, Portuguese and Slovenian delegations have concerns with there respective translation of the regulation.

To pkost's post: by article 1(2) (e) and (ea) devices manufactured utilising transplants, tissues or cells of animal/human origin or their derivatives, which are non-viable or are rendered non-viable, shall be in the scope of the MDR.
There are also specific procedures for the conformity assessment of such products in annex VIII where it is stated that directive 2004/23/EC has to be complied with.
 

pkost

Trusted Information Resource
#7
Re: Clinical requirements for HO devices

To pkost's post: by article 1(2) (e) and (ea) devices manufactured utilising transplants, tissues or cells of animal/human origin or their derivatives, which are non-viable or are rendered non-viable, shall be in the scope of the MDR.
There are also specific procedures for the conformity assessment of such products in annex VIII where it is stated that directive 2004/23/EC has to be complied with.
Well that's irritating (although probably for the best); fortunately I don't work with these types of products any more!

Thanks
 

Chrisx

Involved In Discussions
#8
LOB,

Thanks very much for pointing out the Chapter X, clause 94(7). The immense length of this new regulation makes it very hard to digest. You are correct, there appears to be a grandfather clause for existing products.
 

Chrisx

Involved In Discussions
#9
I am reading this again, and it is very confusing. Hopefully, this will be addressed in the final regulation. Chapter X Article 94 (7) allows for the continued marketing of products identified in Article 1(2) point (e) and (ea). However, Article 1(2) defines the products that the regulation shall not apply to. This is very confusing as it is a double negative. It is stating that products are grandfather in that are identified in a clause that states the regulation doesn't apply. :mad:
 
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