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

Upcoming SoftwareCPR Training Courses:

Public Course – Jan 9-11, 2023 – Risk Management (in-person)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective public training course is now open for registration!

Where:  Tampa, Florida

  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
  • System level hazards analysis – mapping to software, cybersecurity, and usability
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

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

Instructors: Dr. Peter Rech, Brian Pate

Discount Registration through October 31, 2022.  Reserve your spot!

Register here: https://events.eventzilla.net/e/2023-softwarecpr-public-training-course–iso-14971-medical-device-risk-management-a-software-organizations-perspective-2138576610

 

Public Course – Dec 12-15, 2022 – Being Agile & Yet Compliant (virtual)

COST: 4 half days for $1,920 per person

HOURS: 11 am until 3 pm EDT each day

TRAINING LOCATION: Virtual – live online

Register here:

https://events.eventzilla.net/e/december-2022-softwarecpr-agile-and-compliant-training-course-2138573767

 

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