What is required to run human clinical trials in France

#1
I may provide QMS consulting for a startup medical device customer in France. We are working on developing a QMS while planning out a timeline and regulatory pathway.

This may seem a simple question that I could determine myself by looking closely at the new EU MDR regulations, but can anyone tell me whether a company needs to either pass an EU audit or become ISO 13485 certified before they can perform human clinical trials?

Can you link me or attach a document that spells out the process and document requirements?

Thank you.
 
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Marcelo

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#3
As Ronen noted, the MDR does detail all the requirements for a clinical trial in Europe (because the MDR is both for putting the device into market, but also is a regulation for clinical trials in Europe).

However, just take care that each country usually have additional processes and or/requirements. For France , you need to check AnSm requirements, for example, and also IRB requirements from the French organization/s that deals with IRBs.
 

SKM.Sunil

Involved In Discussions
#4
As Ronen noted, the MDR does detail all the requirements for a clinical trial in Europe (because the MDR is both for putting the device into market, but also is a regulation for clinical trials in Europe).

However, just take care that each country usually have additional processes and or/requirements. For France , you need to check AnSm requirements, for example, and also IRB requirements from the French organization/s that deals with IRBs.
Can you please tell me, whether it is required to adhere to ISO14155 in European trials related to MDs? does ICH-GCP plays any role?
 
#5
I have searched through the new EU MDR but do not see any listed requirements for human clinical trials. Is there a companion document that addresses this issue? I've looked at MEDDEV 2.7.1 Rev 4 guidance but it didn't answer this question.
 

SKM.Sunil

Involved In Discussions
#6
I have searched through the new EU MDR but do not see any listed requirements for human clinical trials. Is there a companion document that addresses this issue? I've looked at MEDDEV 2.7.1 Rev 4 guidance but it didn't answer this question.
the Clinical Trials in EU shall be commenced according to ISO14155:2011 (you should read this standard).... But I am not sure if ICH-GCP applicable in any way.........because ISO 14155 is fulfilling all the trial requirements.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
I have searched through the new EU MDR but do not see any listed requirements for human clinical trials. Is there a companion document that addresses this issue? I've looked at MEDDEV 2.7.1 Rev 4 guidance but it didn't answer this question.
Annex XV

ISO 14155 compliance should satisfy the requirements concerning "good clinical practice" listed in Annex XV. There's no obligation to implement harmonized standards but the alternative is justifying how what you do is at par, which is about as onerous as implementing the standard anyway.

Please note that ISO 14155 is currently being revised.
 
#8
Hi Scott,
You will find more information on ANSM internet site:
ansm.sante.fr/Activites/Dispositifs-medicaux-et-dispositifs-medicaux-de-diagnostic-in-vitro/Avis-aux-promoteurs-Formulaires/(offset)/2

I hope you can read French, as ANSM is not very keen in providing information in English. I can give you further help if needed.

Cheers,

Gaëlle
 
#9
As Ronen said.

While law is mandatory, standards are not. Laws furthermore do not refer to standards. However, it is basically impossible to not use standards, as they are basically GASOTA (generall accepted state of the art), and an MDM needs to stick to GASOTA.

Make sure to buy the standards from e.g. BSI, because of harmonised standards.
 
#10
Thank you all for the feedback. The company will be actively looking to hire a local Quality Director that I will work with to design and implement a QMS this year. Your guidance has helped clarify things but lots more to do. Be well.
 
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