Regulatory Open Forum

Hi All,

Do we need to have full product compliance to start the clinical trail or we can have some essential safety requirements met to the start the clinical trail for an active implantable medical device. Can any one throw some insight or guidance on the approach.

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Jayaram Abimanyu
Chennai
India
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Hello Jayaram,

In simple terms, the essential safety requirements of a device need to be met for a clinical trial/clinical investigation, i.e. biocompatibility, electrical safety (maybe not full), some V&V testing, etc.  This is highly dependent on the type of device.  If you are speaking to an active implantable medical device, the expectations for product compliance is product used for clinical trials are highly representative of what is going to the market.  This means safety and even much of the performance profile is already well established.  This may also be based on an pre-market application requirements, such as an IDE in the United States, also the Ethics Committee review, and information related to the medical device.  There are many aspects of this which can and should be considered, so might also recommend some expert advice in trial/investigation management.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 28-Dec-2021 00:05
From: Jayaram Abimanyu
Subject: Guidance for clinical evaluation

Hi All,

Do we need to have full product compliance to start the clinical trail or we can have some essential safety requirements met to the start the clinical trail for an active implantable medical device. Can any one throw some insight or guidance on the approach.

------------------------------
Jayaram Abimanyu
Chennai
India
------------------------------

Jayaram, you need to refer to MDR Article 62(4)(l) for your answer, viz:

"the investigational device(s) in question conform(s) to the applicable general safety and performance requirements set out in Annex I apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subjects. This includes, where appropriate, technical and biological safety testing and pre- clinical evaluation, as well as provisions in the field of occupational safety and accident prevention, taking into consideration the state of the art;"

No guidance is necessary, and there is no allowance for 'partial compliance', especially not for active implantable devices.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Ltd
UK Responsible Person services
Christchurch, UK
+44 1425 489208
rgray@donawa.com
www.donawa.com
------------------------------

Original Message:
Sent: 29-Dec-2021 03:44
From: Richard Vincins
Subject: Guidance for clinical evaluation

Hello Jayaram,

In simple terms, the essential safety requirements of a device need to be met for a clinical trial/clinical investigation, i.e. biocompatibility, electrical safety (maybe not full), some V&V testing, etc.  This is highly dependent on the type of device.  If you are speaking to an active implantable medical device, the expectations for product compliance is product used for clinical trials are highly representative of what is going to the market.  This means safety and even much of the performance profile is already well established.  This may also be based on an pre-market application requirements, such as an IDE in the United States, also the Ethics Committee review, and information related to the medical device.  There are many aspects of this which can and should be considered, so might also recommend some expert advice in trial/investigation management.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 28-Dec-2021 00:05
From: Jayaram Abimanyu
Subject: Guidance for clinical evaluation

Hi All,

Do we need to have full product compliance to start the clinical trail or we can have some essential safety requirements met to the start the clinical trail for an active implantable medical device. Can any one throw some insight or guidance on the approach.

------------------------------
Jayaram Abimanyu
Chennai
India
------------------------------

Just one more point, Jayaram - MDR Annex XV, 'Clinical investigations', chapter II, para 4.1 states, in relation to the documentation that must accompany a clinical investigation application to the competent authority:

"A signed statement by the natural or legal person responsible for the manufacture of the investigational device that the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject."

Without such a statement, the application will be refused.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Ltd
UK Responsible Person services
Christchurch, UK
+44 1425 489208
rgray@donawa.com
www.donawa.com
------------------------------

Original Message:
Sent: 29-Dec-2021 05:04
From: Roger Gray
Subject: Guidance for clinical evaluation

Jayaram, you need to refer to MDR Article 62(4)(l) for your answer, viz:

"the investigational device(s) in question conform(s) to the applicable general safety and performance requirements set out in Annex I apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subjects. This includes, where appropriate, technical and biological safety testing and pre- clinical evaluation, as well as provisions in the field of occupational safety and accident prevention, taking into consideration the state of the art;"

No guidance is necessary, and there is no allowance for 'partial compliance', especially not for active implantable devices.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Ltd
UK Responsible Person services
Christchurch, UK
+44 1425 489208
rgray@donawa.com
www.donawa.com

Original Message:
Sent: 29-Dec-2021 03:44
From: Richard Vincins
Subject: Guidance for clinical evaluation

Hello Jayaram,

In simple terms, the essential safety requirements of a device need to be met for a clinical trial/clinical investigation, i.e. biocompatibility, electrical safety (maybe not full), some V&V testing, etc.  This is highly dependent on the type of device.  If you are speaking to an active implantable medical device, the expectations for product compliance is product used for clinical trials are highly representative of what is going to the market.  This means safety and even much of the performance profile is already well established.  This may also be based on an pre-market application requirements, such as an IDE in the United States, also the Ethics Committee review, and information related to the medical device.  There are many aspects of this which can and should be considered, so might also recommend some expert advice in trial/investigation management.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 28-Dec-2021 00:05
From: Jayaram Abimanyu
Subject: Guidance for clinical evaluation

Hi All,

Do we need to have full product compliance to start the clinical trail or we can have some essential safety requirements met to the start the clinical trail for an active implantable medical device. Can any one throw some insight or guidance on the approach.

------------------------------
Jayaram Abimanyu
Chennai
India
------------------------------

Dear Jayaram

 

Prior to starting your clinical trial, you should ensure that your medical device is fully compliant with all applicable regulatory requirements of the countries in which you wish to market your device. There should be a design freeze.

 

Please remember a clinical trial is an expensive exercise and thereby, it is as well in your interest that your medical device is fully compliant. Major design changes following the clinical trial most likely will require you to run an additional clinical trial again, depending on your assessment (i.e. business & medical device risk assessment, etc.) and applicable regulation.

 

It is also in your company's interest that medical device meets the expected safety and effectiveness in terms of state of the art, standards, and regulation when the medical device is brought to the market (following the completion of the clinical trial and market approval).  

Please be aware of the heightened awareness of the public with regards to medical device incidents as well as the increase in the public access and depth of reporting of vigilance events. We are, as well, in a highly linked and digital world where information regarding effectiveness and safety is shared quickly among interested parties. 

 

Best Regards,
Stephanie

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Stephanie Grassmann
Managing Director of MedTechXperts Ltd
Biberstein
Switzerland
------------------------------

Original Message:
Sent: 28-Dec-2021 00:05
From: Jayaram Abimanyu
Subject: Guidance for clinical evaluation

Hi All,

Do we need to have full product compliance to start the clinical trail or we can have some essential safety requirements met to the start the clinical trail for an active implantable medical device. Can any one throw some insight or guidance on the approach.

------------------------------
Jayaram Abimanyu
Chennai
India
------------------------------