Regulatory Open Forum

​Hi All,

Like US has a HUD device designation and an HDE pathway for those devices.

Does any similar pathway exist in EU??

Any guidance is highly appreciated.

Best regards,
Meenakshi

------------------------------
Meenakshi Verma
Regulatory Affairs Professional - Medical Devices
Ontario
Canada
------------------------------

Meenakshi,

Under the Medical Device Directive 93/42/EEC there is no humanitarian exemption like in the United States.  The closest you can get to that type of definition of humanitarian device is Annex VIII which is Devices for Special Purposes.  While this is not humanitarian use, custom or Special Purpose devices could be considered, but this is really on the edge as custom devices are one-off type of devices.  Not a number of devices intended for a small segment of the population such as the FDA's process.

Unfortunately, the Medical Device Regulation 2017/745 EU also did not add anything regarding humanitarian exemption and there are no MEDDEV documents or other guidance providing a route for products intended for a small group of population.  The intent of the MDD and MDR is that any device placed on the market for use in humans must be CE Marked.  With that said, there are some Member States that have individual regulations for humanitarian use, i.e. MHRA Exceptional use of non-CE marked medical devices, this would be handled by each Member State and some do not have any exemption process.

Whether you are talking FDA or EU CE Mark, there is still a large amount of information that has to be compiled to support the safety (and performance) of a device, which results in the device ultimately needing CE Mark.  You could discuss with a Notified Body about getting a "speedier" approval process for a humanitarian need.

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

Original Message:
Sent: 16-Aug-2018 13:32
From: Meenakshi Verma
Subject: HDE- Any similar process in EU?

​Hi All,

Like US has a HUD device designation and an HDE pathway for those devices.

Does any similar pathway exist in EU??

Any guidance is highly appreciated.

Best regards,
Meenakshi

------------------------------
Meenakshi Verma
Regulatory Affairs Professional - Medical Devices
Ontario
Canada
------------------------------

Richard, similarly do you know if a HUD or Orphan Product (specifically for pediatrics) exists for Health Canada?

Thanks,
Mike

------------------------------
Michael Nilo
Network Regulatory Partners
Portland OR
United States
------------------------------

Original Message:
Sent: 17-Aug-2018 05:15
From: Richard Vincins
Subject: HDE- Any similar process in EU?

Meenakshi,

Under the Medical Device Directive 93/42/EEC there is no humanitarian exemption like in the United States.  The closest you can get to that type of definition of humanitarian device is Annex VIII which is Devices for Special Purposes.  While this is not humanitarian use, custom or Special Purpose devices could be considered, but this is really on the edge as custom devices are one-off type of devices.  Not a number of devices intended for a small segment of the population such as the FDA's process.

Unfortunately, the Medical Device Regulation 2017/745 EU also did not add anything regarding humanitarian exemption and there are no MEDDEV documents or other guidance providing a route for products intended for a small group of population.  The intent of the MDD and MDR is that any device placed on the market for use in humans must be CE Marked.  With that said, there are some Member States that have individual regulations for humanitarian use, i.e. MHRA Exceptional use of non-CE marked medical devices, this would be handled by each Member State and some do not have any exemption process.

Whether you are talking FDA or EU CE Mark, there is still a large amount of information that has to be compiled to support the safety (and performance) of a device, which results in the device ultimately needing CE Mark.  You could discuss with a Notified Body about getting a "speedier" approval process for a humanitarian need.

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

Original Message:
Sent: 16-Aug-2018 13:32
From: Meenakshi Verma
Subject: HDE- Any similar process in EU?

​Hi All,

Like US has a HUD device designation and an HDE pathway for those devices.

Does any similar pathway exist in EU??

Any guidance is highly appreciated.

Best regards,
Meenakshi

------------------------------
Meenakshi Verma
Regulatory Affairs Professional - Medical Devices
Ontario
Canada
------------------------------

Hi Michael,

As per my knowledge - the Canadian Medical Device regulations do no talk about the Orphan device status.

A Special Access Program is available - Special Access is requested in emergency use cases or when conventional therapies have failed, are unavailable or are unsuitable to treat a patient.
 
https://www.canada.ca/en/health-canada/services/drugs-health-products/special-access/medical-devices.html

Best regards,
Meenakshi

------------------------------
Meenakshi Verma
Regulatory Affairs Professional - Medical Devices
Ontario
Canada
------------------------------

Original Message:
Sent: 17-Aug-2018 10:06
From: Michael Nilo
Subject: HDE- Any similar process in EU?

Richard, similarly do you know if a HUD or Orphan Product (specifically for pediatrics) exists for Health Canada?

Thanks,
Mike

------------------------------
Michael Nilo
Network Regulatory Partners
Portland OR
United States

Original Message:
Sent: 17-Aug-2018 05:15
From: Richard Vincins
Subject: HDE- Any similar process in EU?

Meenakshi,

Under the Medical Device Directive 93/42/EEC there is no humanitarian exemption like in the United States.  The closest you can get to that type of definition of humanitarian device is Annex VIII which is Devices for Special Purposes.  While this is not humanitarian use, custom or Special Purpose devices could be considered, but this is really on the edge as custom devices are one-off type of devices.  Not a number of devices intended for a small segment of the population such as the FDA's process.

Unfortunately, the Medical Device Regulation 2017/745 EU also did not add anything regarding humanitarian exemption and there are no MEDDEV documents or other guidance providing a route for products intended for a small group of population.  The intent of the MDD and MDR is that any device placed on the market for use in humans must be CE Marked.  With that said, there are some Member States that have individual regulations for humanitarian use, i.e. MHRA Exceptional use of non-CE marked medical devices, this would be handled by each Member State and some do not have any exemption process.

Whether you are talking FDA or EU CE Mark, there is still a large amount of information that has to be compiled to support the safety (and performance) of a device, which results in the device ultimately needing CE Mark.  You could discuss with a Notified Body about getting a "speedier" approval process for a humanitarian need.

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

Original Message:
Sent: 16-Aug-2018 13:32
From: Meenakshi Verma
Subject: HDE- Any similar process in EU?

​Hi All,

Like US has a HUD device designation and an HDE pathway for those devices.

Does any similar pathway exist in EU??

Any guidance is highly appreciated.

Best regards,
Meenakshi

------------------------------
Meenakshi Verma
Regulatory Affairs Professional - Medical Devices
Ontario
Canada
------------------------------

Thanks so much Richard!! It was very helpful.

Best regards,
Meenakshi

------------------------------
Meenakshi Verma
Regulatory Affairs Professional - Medical Devices
Ontario
Canada
------------------------------

Original Message:
Sent: 17-Aug-2018 05:15
From: Richard Vincins
Subject: HDE- Any similar process in EU?

Meenakshi,

Under the Medical Device Directive 93/42/EEC there is no humanitarian exemption like in the United States.  The closest you can get to that type of definition of humanitarian device is Annex VIII which is Devices for Special Purposes.  While this is not humanitarian use, custom or Special Purpose devices could be considered, but this is really on the edge as custom devices are one-off type of devices.  Not a number of devices intended for a small segment of the population such as the FDA's process.

Unfortunately, the Medical Device Regulation 2017/745 EU also did not add anything regarding humanitarian exemption and there are no MEDDEV documents or other guidance providing a route for products intended for a small group of population.  The intent of the MDD and MDR is that any device placed on the market for use in humans must be CE Marked.  With that said, there are some Member States that have individual regulations for humanitarian use, i.e. MHRA Exceptional use of non-CE marked medical devices, this would be handled by each Member State and some do not have any exemption process.

Whether you are talking FDA or EU CE Mark, there is still a large amount of information that has to be compiled to support the safety (and performance) of a device, which results in the device ultimately needing CE Mark.  You could discuss with a Notified Body about getting a "speedier" approval process for a humanitarian need.

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

Original Message:
Sent: 16-Aug-2018 13:32
From: Meenakshi Verma
Subject: HDE- Any similar process in EU?

​Hi All,

Like US has a HUD device designation and an HDE pathway for those devices.

Does any similar pathway exist in EU??

Any guidance is highly appreciated.

Best regards,
Meenakshi

------------------------------
Meenakshi Verma
Regulatory Affairs Professional - Medical Devices
Ontario
Canada
------------------------------

Michael,

As Meenakshi indicated there is the Special Access Program in Canada - though again nothing quite the same as FDA's HDE process.

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

Original Message:
Sent: 17-Aug-2018 10:22
From: Meenakshi Verma
Subject: HDE- Any similar process in EU?

Thanks so much Richard!! It was very helpful.

Best regards,
Meenakshi

------------------------------
Meenakshi Verma
Regulatory Affairs Professional - Medical Devices
Ontario
Canada

Original Message:
Sent: 17-Aug-2018 05:15
From: Richard Vincins
Subject: HDE- Any similar process in EU?

Meenakshi,

Under the Medical Device Directive 93/42/EEC there is no humanitarian exemption like in the United States.  The closest you can get to that type of definition of humanitarian device is Annex VIII which is Devices for Special Purposes.  While this is not humanitarian use, custom or Special Purpose devices could be considered, but this is really on the edge as custom devices are one-off type of devices.  Not a number of devices intended for a small segment of the population such as the FDA's process.

Unfortunately, the Medical Device Regulation 2017/745 EU also did not add anything regarding humanitarian exemption and there are no MEDDEV documents or other guidance providing a route for products intended for a small group of population.  The intent of the MDD and MDR is that any device placed on the market for use in humans must be CE Marked.  With that said, there are some Member States that have individual regulations for humanitarian use, i.e. MHRA Exceptional use of non-CE marked medical devices, this would be handled by each Member State and some do not have any exemption process.

Whether you are talking FDA or EU CE Mark, there is still a large amount of information that has to be compiled to support the safety (and performance) of a device, which results in the device ultimately needing CE Mark.  You could discuss with a Notified Body about getting a "speedier" approval process for a humanitarian need.

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

Original Message:
Sent: 16-Aug-2018 13:32
From: Meenakshi Verma
Subject: HDE- Any similar process in EU?

​Hi All,

Like US has a HUD device designation and an HDE pathway for those devices.

Does any similar pathway exist in EU??

Any guidance is highly appreciated.

Best regards,
Meenakshi

------------------------------
Meenakshi Verma
Regulatory Affairs Professional - Medical Devices
Ontario
Canada
------------------------------