Regulatory Open Forum

I'm working with a medical device company who wishes to conduct an Exploratory / Early Feasibility Clinical Investigation to determine if a device has the potential to accelerate the correction of a medical condition. Our final device in question, will be Class IIb implantable, but for the purpose of the clinical investigation, we will be attaching a custom-made / in house manufactured device (non-CE Marked) to an existing implant. My competent authority has provided the opinion that as we are looking at safety and performance of a device, it looks like Article 62 applies. The CA's opinion was that even if the data from the study will not be directly used for a regulatory submission, if the data informs other future studies that may be used for regulatory submission, then it falls under Article 62.

We believe we fall under Article 82, as this is a Pilot Stage Exploratory / Early Feasibility Clinical Investigation of a non-CE Marked device to determine the feasibility of designing a device that can accelerate the correction of a medical condition.  Would like to hear other views on this.

Additionally, as the trial that we will be conducting will be an Exploratory / Early Feasibility Clinical Investigation, do we need to comply with all of the requirements of ISO 14155?

Clause 6.10 Labelling states

"The investigational device, the instructions for use, or the packaging shall indicate that the investigational device is exclusively for use in a clinical investigation, unless this is not required (see I.7)".

 NOTE See ISO 15223‑1 and national or regional regulations for further information on labelling."

Annex I, I.7 a) states "Pre-market exploratory clinical investigation: all principles in this document apply with the exception that no mandatory (pre-)specification of a statistical hypothesis is required."

Do we need to comply with all of the requirements of ISO 15223‑1 for Labeling, specifically UDI requirements, for this exploratory device or can we claim an exemption from this requirement and note it in the CIP?

Appreciate your help and guidance!

I'm working with a medical device company who wishes to conduct an Exploratory / Early Feasibility Clinical Investigation to determine if a device has the potential to accelerate the correction of a medical condition. Our final device in question, will be Class IIb implantable, but for the purpose of the clinical investigation, we will be attaching a custom-made / in house manufactured device (non-CE Marked) to an existing implant. My competent authority has provided the opinion that as we are looking at safety and performance of a device, it looks like Article 62 applies. The CA's opinion was that even if the data from the study will not be directly used for a regulatory submission, if the data informs other future studies that may be used for regulatory submission, then it falls under Article 62.

We believe we fall under Article 82, as this is a Pilot Stage Exploratory / Early Feasibility Clinical Investigation of a non-CE Marked device to determine the feasibility of designing a device that can accelerate the correction of a medical condition.  Would like to hear other views on this.

Additionally, as the trial that we will be conducting will be an Exploratory / Early Feasibility Clinical Investigation, do we need to comply with all of the requirements of ISO 14155?

Clause 6.10 Labelling states

"The investigational device, the instructions for use, or the packaging shall indicate that the investigational device is exclusively for use in a clinical investigation, unless this is not required (see I.7)".

 NOTE See ISO 15223‑1 and national or regional regulations for further information on labelling."

Annex I, I.7 a) states "Pre-market exploratory clinical investigation: all principles in this document apply with the exception that no mandatory (pre-)specification of a statistical hypothesis is required."

Do we need to comply with all of the requirements of ISO 15223‑1 for Labeling, specifically UDI requirements, for this exploratory device or can we claim an exemption from this requirement and note it in the CIP?

Appreciate your help and guidance!

I'm working with a medical device company who wishes to conduct an Exploratory / Early Feasibility Clinical Investigation to determine if a device has the potential to accelerate the correction of a medical condition. Our final device in question, will be Class IIb implantable, but for the purpose of the clinical investigation, we will be attaching a custom-made / in house manufactured device (non-CE Marked) to an existing implant. My competent authority has provided the opinion that as we are looking at safety and performance of a device, it looks like Article 62 applies. The CA's opinion was that even if the data from the study will not be directly used for a regulatory submission, if the data informs other future studies that may be used for regulatory submission, then it falls under Article 62.

We believe we fall under Article 82, as this is a Pilot Stage Exploratory / Early Feasibility Clinical Investigation of a non-CE Marked device to determine the feasibility of designing a device that can accelerate the correction of a medical condition.  Would like to hear other views on this.

Additionally, as the trial that we will be conducting will be an Exploratory / Early Feasibility Clinical Investigation, do we need to comply with all of the requirements of ISO 14155?

Clause 6.10 Labelling states

"The investigational device, the instructions for use, or the packaging shall indicate that the investigational device is exclusively for use in a clinical investigation, unless this is not required (see I.7)".

 NOTE See ISO 15223‑1 and national or regional regulations for further information on labelling."

Annex I, I.7 a) states "Pre-market exploratory clinical investigation: all principles in this document apply with the exception that no mandatory (pre-)specification of a statistical hypothesis is required."

Do we need to comply with all of the requirements of ISO 15223‑1 for Labeling, specifically UDI requirements, for this exploratory device or can we claim an exemption from this requirement and note it in the CIP?

Appreciate your help and guidance!