First, I recommend being careful about equating or confusing the scope of the requirements in EU MDR Article 23 (i.e., independent "after-market" commercialization of parts and components) with the separate requirements applicable to the original manufacturer of a finished device and its various parts and components. For example, I wouldn't apply Article 23 to the scenario where the manufacturer of a diagnostic machine merely uses replacement parts during routine in-house or onsite servicing or repair of a customer's machine. Article 23 should only get triggered if an economic operator provides separately-labeled/packaged "after-market" parts or components to the marketplace.
For an original manufacturer of a diagnostic machine who merely uses its own replacement parts during in-house or onsite servicing or repair of a customer's machine, some NBs would expect that a revised spare part is to be reflected in the TD. For example, BSI expects the TD to contain a Bill of Materials along with component grade, quality, reference codes, supplier details, etc. Accordingly, some of those TD aspects would generally require a TD update to reflect the revised
spare parts, even if the revised part doesn't affect the safety or performance of the MD.------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 25-Feb-2022 05:45
From: George Magkaniotis
Subject: 'Medical Device spare part(s)'
Hello,
In cases where a spare part is replaced or discontinued, where that doesn't affect the safety or performance of the MD.
Does the above pose a requirement for updating the TD?
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George Magkaniotis
R&D Systems Test Engineer
Tyresö
Sweden
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