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.
 
Elsmar Forum Sponsor
Q

QA-Man

#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:
 
Thread starter Similar threads Forum Replies Date
shimonv Minimum 60601 requirements for a clinical trial IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S A clinical performance evaluation study with an IVD product as Investagional Use product - Clinical Monitor requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Clinical evaluation for a class IIa medical device - EU MDR Requirements EU Medical Device Regulations 3
S Clinical Studies - Premarket Submission Requirements Canada Medical Device Regulations 1
F China Clinical Trials Requirements Other Medical Device Regulations World-Wide 2
L EU MDR CRO (Contract Research Organization) requirements for Clinical Investigations EU Medical Device Regulations 1
Z Labeling Requirements for Free Samples supporting Clinical Evaluation EU Medical Device Regulations 2
I FDA Class II Medical Device Clinical Trials and and FDA IDE Requirements US Food and Drug Administration (FDA) 3
L EU Class IIa Clinical Trials - Quality Requirements EU Medical Device Regulations 3
MDD_QNA Clinical data requirements - Changing a Class I Medical Device to Class II EU Medical Device Regulations 5
D Dual Lot Manufacturing requirements for Clinical Customers Manufacturing and Related Processes 3
A Singapore - Requirements for Import of Medical Devices for Clinical Trial Other Medical Device Regulations World-Wide 2
A Design Control Requirements: IDE exempt, NSR Device (Clinical Study) US Food and Drug Administration (FDA) 2
M Category I Medical Device Clinical Data Requirements EU Medical Device Regulations 3
C IFU Language Requirements for FDA Clinical Study conducted in EU EU Medical Device Regulations 3
C Clinical Requirements for Class III Spinal Implants EU Medical Device Regulations 2
R CE Mark requirements on US Clinical Trial Product CE Marking (Conformité Européene) / CB Scheme 2
K Clinical Evaluation Report Article Summary Requirements EU Medical Device Regulations 5
D ETO Sterility Requirements for FIM Clinical Study in Europe Other Medical Device Regulations World-Wide 3
R CRO (Contract Research Organization) Requirements for MDD Clinical Investigations EU Medical Device Regulations 5
P QA requirements for non CE-Marked Device participating in a Clinical Study EU Medical Device Regulations 1
B US Clinical Trials Requirements for New Devices? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T Requirements for Clinical Trials worldwide ISO 13485:2016 - Medical Device Quality Management Systems 2
R Design Validation and Clinical Evaluations to meet ISO 13485 requirements Design and Development of Products and Processes 3
E ISO 13485 in Clinical Trial conduct: Applicable or No ISO 13485:2016 - Medical Device Quality Management Systems 2
L Clinical Trial and Finished Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
shimonv Clinical evaluation report for class I device EU Medical Device Regulations 3
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
P GSPRs / Clinical Evaluation EU Medical Device Regulations 3
P IDEs and Clinical Investigators - Advice About Records? Other US Medical Device Regulations 3
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
silentmonkey Overall Benefit/Risk Analysis - Risk Management VS Clinical Evaluation ISO 14971 - Medical Device Risk Management 3
Q Summative Usability Evaluation Testing: prior or during Clinical Investigation? Human Factors and Ergonomics in Engineering 6
P Clinical Trial Requirement - No equivalent devices in the market CE Marking (Conformité Européene) / CB Scheme 3
M Clinical Decision Support Software Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Regular updates of clinical evaluation report EU Medical Device Regulations 6
M Clinical Benefit of device that only aids in a process for managing or treating disease EU Medical Device Regulations 2
R Clinical accuracy and repeatability of IR(infrared) thermometer, no maximum error criteria is recommended in ISO Other Medical Device Related Standards 11
C EU MDR - Annex II 6.1 Pre-clinical and clinical data EU Medical Device Regulations 4
M Clinical Evaluation Benchmark vs. Equivalent EU Medical Device Regulations 2
D Classification of product for clinical trials EU Medical Device Regulations 14
D Deciding whether or not pre-market clinical investigation is required for low risk device EU Medical Device Regulations 5
S Australia TGA Clinical Evaluation Report (CER) Other Medical Device Regulations World-Wide 0
L Clinical research - Request from ANVISA ISO 14971 - Medical Device Risk Management 1
E Use of OQ cleared batch for stability and clinical study use ISO 13485:2016 - Medical Device Quality Management Systems 0
B Clinical Evaluation Expert Panels - MDR EU Medical Device Regulations 1
M Clinical Development Plan - Advice Requested EU Medical Device Regulations 11
T Clinical evaluation of a new medical device EU Medical Device Regulations 0
dgrainger Informational MDCG 2020:13 - Clinical evaluation assessment report template EU Medical Device Regulations 0
J Need for a cleanroom in the manufacture of a medical device for a clinical trial EU Medical Device Regulations 4

Similar threads

Top Bottom