Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear Members,

Do we need to compose a UKCA technical file in order to UKCA mark the device, or is it sufficient to update the Quality Management System (QMS) and compose a bridging statement to make the technical documentation compliant with the Medical Device Regulation (MDR)? Then, we can compose a UKCA declaration of conformity and proceed with marking the device. I am referring specifically to Class I self-certified MD

Thank you 

Anon,

The medical device regulations in the UK are essentially the same as the previous EU MDD - which always required a "technical file" or referred to as Technical Documentation now.  The simple answer to the question is yes, a UK Technical File/Technical Documentation file is needed for all medical devices, even Class I self-declare devices.  These documentation are part of your Quality Management System (QMS) as a record.  When requested from a regulatory agency, such as the MHRA, this would need to be "surrendered" for review.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 15-Apr-2024 07:32
From: Anonymous Member
Subject: UKCA technical documentation

This message was posted by a user wishing to remain anonymous

Dear Members,

Do we need to compose a UKCA technical file in order to UKCA mark the device, or is it sufficient to update the Quality Management System (QMS) and compose a bridging statement to make the technical documentation compliant with the Medical Device Regulation (MDR)? Then, we can compose a UKCA declaration of conformity and proceed with marking the device. I am referring specifically to Class I self-certified MD

Thank you 

In addition to what Richard wrote: your UKRP ( the UK version of the authorized representative) will review your technical documentation. Therefore, you must be able to produce that. MDR/IVDR compliant documentation will be compliant to the AIMDD/MDD/IVDD. However, there are several typical GB-market related issues that must be addressed. As a result, you have to go over all of the documentation to ensure it is UKCA compliant. 

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Ronald Boumans
MDR Expert
Super PRRC
Netherlands
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Original Message:
Sent: 15-Apr-2024 07:32
From: Anonymous Member
Subject: UKCA technical documentation

This message was posted by a user wishing to remain anonymous

Dear Members,

Do we need to compose a UKCA technical file in order to UKCA mark the device, or is it sufficient to update the Quality Management System (QMS) and compose a bridging statement to make the technical documentation compliant with the Medical Device Regulation (MDR)? Then, we can compose a UKCA declaration of conformity and proceed with marking the device. I am referring specifically to Class I self-certified MD

Thank you