The document is NOT a standard as a Technical Report. It provides information on how to implement postmarket surveillance and it does not establish requirements. AAMI uses the name "Technical Information Report" to indicate it only contains information. It also as Richard points out, indicates you must comply with any applicable regulatory requirements in the markets served.
technical Reports are different from standards and are able to be revised more easily with less review and approval. This is because the documents are not establishing requirements, but providing technical information On the topic discussed.
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Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com------------------------------
Original Message:
Sent: 14-Feb-2020 04:25
From: Richard Vincins
Subject: Postmarket Surveillance
Hi Peter,
I would not expect it to meet full EU MDR compliance because this is an ISO standard and a Technical Report at that. This means really it is a bit better than a guidance document, to be used internationally through all jurisdictions. .And I do view this as a helpful document to design, structure, and manage a post market surveillance system, but it will be each company's responsibility to then apply it to specific regulatory requirements where they market product and gather post market data.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 14-Feb-2020 02:15
From: Peter Reijntjes
Subject: Postmarket Surveillance
I have not yet bought and read the document, but on the AAMI store and as introduction of the TR itself is written 'PMS information may include material that requires reporting to Regulatory Authorities. The proposed Technical Report will not provide information for such reporting, nor for achieving compliance with any other (PMS) requirement by Regulatory Authorities. Market surveillance by national authorities, as well as actions legally required to be performed by manufacturers as part of PMS or vigilance are outside the scope of the proposed Technical Report'.
I do not expect it to be MDR compliant.
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Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands
Original Message:
Sent: 13-Feb-2020 15:53
From: Anonymous Member
Subject: Postmarket Surveillance
This message was posted by a user wishing to remain anonymous
Will this be EU MDR compliant?
Original Message:
Sent: 07-Feb-2020 11:06
From: Edwin Bills
Subject: Postmarket Surveillance
Just received an announcement of the Draft ISO Technical Report on Postmarket Surveillance availability from AAMI. The TR is designed to provide guidance for medical device manufacturers in developing systems to meet regulatory requirements.
Just Released! AAMI Draft Technical Information Report: AAMI/ISO DTIR20416:2020, Medical devices-Post-market surveillance for manufacturers
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Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
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