Hello Anon,
I support what Anne says is although post market surveillance in the EU MDR/IVDR does not say Europe/European Union specifically, there is implied context it applies universally to the product distribution. Most regulatory agencies have that approach as well. Because now post market surveillance is an "active" process meaning being aware of what is happening with your products in the market. Therefore, say a company manufacturing in United States and ships/distributes in Europe, encounters an issue in the United States after few days of releasing a product. If the product is still in transit or warehouse in Europe, then it could be anticipated or stopped from further distribution. Also the analysis of the data is important because if there is a large sales volume in United States and very small in Europe, than analysing only Europe may not give an indicator or as Anne said the proportion is out of keel with the rest of the volume distribution. With that said, as part of post market surveillance (depends on type of device) we usually conduct analysis for all markets and then do a subset of Europe, e.g. 2 or 3 adverse events in U.S., but nothing in Europe so conducting almost a comparison.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 16-Feb-2022 22:14
From: Anne LeBlanc
Subject: MDR/IVDR PMS Plan - Include devices sold in other jurisdictions?
Hi Anon
MDR Article 83 doesn't suggest it should be limited to EU jurisdictions. It says the process needs to be part of the quality management system, which suggests something universal. Since one purpose is to detect a need for preventive action, I'd imagine in most cases you'd want to consider things going wrong wherever they might be.
Would the effort involved in gathering data in those places be onerous out of proportion with the risk of the device? You're probably already handling complaints for every jurisdiction.
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Anne LeBlanc
United States
Original Message:
Sent: 16-Feb-2022 12:46
From: Anonymous Member
Subject: MDR/IVDR PMS Plan - Include devices sold in other jurisdictions?
This message was posted by a user wishing to remain anonymous
A manufacturer has a single device available in multiple jurisdictions, with the same design and intended use. Is the manufacturer required to include the devices that are not CE-marked and sold in other jurisdictions in the scope of the MDR/IVDR PMS Plan?