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About the MDR transition deadline, major challenges and pragmatic solutions

In just under a week, 26 May 2021 will be a date that is particularly important to manufacturers of medical products. Not least because there has been a lot of discussion about the end of the transitional period for the European Medical Devices Regulation 2017/745. Even though manufacturers have been granted another year to adapt their medical devices to the regulatory requirements due to the Corona pandemic, one thing has been noticeable above all in recent months: uncertainty.

Why you don’t have to be uncertain? Because you are not left alone with the new regulatory requirements and changes. Here is a brief overview of the four mistakes you can avoid, especially when developing medical software.

What are the four mistakes you can avoid?

  • Starting an implementation too early

    Especially in view of the increasingly strict regulatory requirements of the MDR, one of the most common mistakes is to start with the implementation without having a concrete procedure or the know-how about the individual activities and documents.

    This not only creates many security gaps and a large number of SOUPs are deployed unplanned, but also an unstructured, untestable architecture and missing documentation. Closing these gaps late in the life cycle requires a lot of effort and often jeopardises the planned release date.

  • Plan too many features

    A second mistake is to plan too many features for the first version. This overlap delays the time to market. It is therefore better to start with a key feature and add supplements according to the needs of users and patients.

    This possibility is also available for medical products. An iterative process is possible if the significance of new features is clarified in advance from a regulatory perspective.

  • Underestimate Post-Market Surveillance

    The third mistake is to underestimate post-market surveillance. Especially in the case of apps, some manufacturers underestimate the effort of platform and SOUP surveillance. This is where it pays off if verification is not automated, but has to be carried out manually each time on a new OS/browser. In addition, there are often no mechanisms for blocking apps, so that once they are available in the apps store, they can no longer be controlled by manufacturers.

  • Neglect cybersecurity

    The fourth mistake is to neglect cybersecurity, which has become a priority for the Notified Body. It is better to be able to demonstrate an overview of the thought-identified cybersecurity risks in relation to the product and the security concepts integrated in the project.

    The assessment of potential risk factors is also part of this. A cybersecurity analysis according to FDA and/or MDCG requirements is a must and should not be missing in any project plan. The determined measures should of course also find their way into the product. So plan enough time for the implementation of the security concepts.

Use the knowledge of experts to avoid mistakes. We are happy to advise and support you

  • in the design and development of medical Software products
  • on Regulatory issues
  • Cybersecurity, data protection and DSGVO
  • with the placing on the market, together with the experts from BAYOOCARE
    and in Post-Market Surveillance

Did you know ...

… that the Regulation on In-Vitro Diagnostics will come into force from 26 May 2022?

Use the coming months to clarify open questions.

Seen it already? The MDR panel of experts

Who are the Medical Device Experts?

Would you like to learn more? Please just contact us.

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