For practical intents and purposes, remember that "placing on the market" and "making available on the market" are essentially shipment-by-shipment concepts. In other words, every shipment will involve a placing on the market (i.e., the first making available) or further making(s) available. It is critical to understand these concepts to properly comply with EU MDR Articles 13.2 and 14.2.
Accordingly, the verifications of EU MDR Articles 13.2 and 14.2 must in fact be suitably assured for each shipment. However, commensurate with risk, such verifications may be achieved via a combination of contractual, time-zero, and real-time verifications.
For example, it is typical for all risk classes that a time-zero detailed review of the label and IFU artwork is performed to confirm compliant information (e.g., presence of the CE mark; conforming instructions for use, etc.). And likewise, for the Declaration of Conformity. But unless and until there is a significant change thereafter, such detailed reviews aren't sensible or necessary to be literally redone for each shipment. Instead, such time-zero verifications may be extrapolated onto each shipment made thereafter via "virtual" verification. Remember that it has been a longstanding European precedent (originating from Europe's "common framework") that the opening of packages by importers and distributors is generally to be avoided where appropriate.
That said, there will always remain a necessary amount of real-time shipment-by-shipment verification. Such real-time verifications may be accomplished via methods such as direct physical verification of the actual product and/or "virtual" verifications such as via photography or paper-based desk reviews. The goal of such real-time verifications is to provide sufficient assurance that the product is not damaged, contaminated, mixed-up, counterfeit, incomplete, mislabeled, etc. Again, the amount, frequency, and complexity of such real-time verifications should be devised commensurate with risk.
Hope this helps.
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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 13-May-2021 02:53
From: Anonymous Member
Subject: Importers and distributors under MDR - interest point of view
This message was posted by a user wishing to remain anonymous
This message was posted by a user wishing to remain anonymous
Hello experts!
Let me make a question concerning the general obligations of importers and distributors under the EU MDR 2017/745: how do you interpret Articles 13.2 and 14.2?
Articles 13.2 states that "In order to place a device on the market, importers shall verify...": it seems to suggest that all checks by the EU importer shall be conducted at the moment of inbound acceptance only the first time the EU importer receives the medical device. Or those checks shall be conducted every time the importer receives it?
Article 14.2 declares that "When making a device available on the market, distributors shall...": it seems to suggest that distributors shall conduct a sample verification on devices before the shipment to the customer.
What do you think? What is the difference between the moment when importers and distributors shall conduct the checks?
Thanks in advance to anyone could provide me with a useful and clear reply!