EU MDR Trilogue Agreement

This agreement includes a number of clarifications to the EU Medical Device Regulations.  The Environment, Public Health and Food Safety (ENVI) Committee of the European Parliament and Council’s Committee of Permanent Representatives (COREPER) voted to endorse the trilogue agreement on June 15.  The text of the draft MDR is at the link provided.  The text still needs to have legal editing and translation before it will be published in the Official Journal.  This is expected around the end of the year and there will be a three year transition so it will be enforced around the beginning of 2020.  A couple of things specific to software in the MDR:

  1. “It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, is qualified as a medical device, while software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being application is not a medical device. The qualification of software, either as device or accessory, is independent of its location or type of interconnection between the software and a device.”
  2. One of the risks that must be removed or reduced is “the risks associated with the possible negative interaction between software and the IT environment within which it operates and interacts” (Annex I Clause 11.2)
    • In the specific requirement for software in Annex I Clause 14.2 the phrase including information security has been added to the list that software must consider and use state of the art principles.
    • Software intended to be used with mobile platforms needs to consider specific features of mobile devices.
    • A new requirement was added “The manufacturer shall describe minimum requirements on hardware, IT networks characteristics and IT security measures, including protection against unauthorized access, necessary to run the software as intended.”
    • Requirements for software placement for software.
    • Classification rules for software as a medical device (Annex VII section III clause 5.2a.).  These appear to be taken from the IMDRF SaMD classification rules.

Agreement can be viewed at this link:  EU-mdr-text-06-2016

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IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

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Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

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Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

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Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

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