Your particular UK MDR conformity assessment basis (e.g., MDD-based, EU MDR-based, or direct UK MDR-based) needs to be known in order to answer definitively. But generally, when an economic operator like an importer or any other economic operator independently performs manufacturing operations like incorporating an unauthorized part or component into the subject device, then such economic operator automatically becomes the responsible manufacturer for that device. This can put both it and the original manufacturer and the user in harm's way (regarding compliance and/or safety).
In contrast, the use of an unauthorized "accessory" (i.e., a true "accessory" as legislatively defined) with the subject device would constitute misuse and is the responsibility of the original manufacturer. The ultimate impact of that misuse is to be assessed and resolved commensurate with risk, up to and including FSCA.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 23-Apr-2024 19:27
From: Anonymous Member
Subject: Use of unauthorised parts or accessories
This message was posted by a user wishing to remain anonymous
Hi,
What's the regulatory impact and responsibility when an unauthorized part or accessory is used on the device by the importer , with particular reference to UK?
Thanks