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Common Pitfalls in Passing Performance Evaluations Mandated Under the New IVDR

Published on Jul 11, 2024

The transition from IVDD to IVDR has introduced more stringent requirements and posed several challenges for organisations.

Here are a few of the common pitfalls that organisations face when attempting to pass performance evaluations under the new IVDR:

  • Poor Understanding of Regulatory Changes: Keeping abreast of the regulatory changes associated with the new IVDR is challenging. Organisations that do not fully comprehend these changes may fail to comply with the new requirements.
  • Incomplete Documentation: Comprehensive documentation throughout the device lifecycle is demanded under the IVDR. Inadequate and incomplete documentation can result in non-compliance and failed Notified Body evaluations.
  • Lack of Training and Expertise: Ensuring that staff are adequately trained and knowledgeable about IVDR requirements is crucial. Organisations that do not invest in training may face difficulties in meeting regulatory standards. Specialist consultancies can help also.
  • Transition Period Mismanagement: Mismanagement of the IVDR transition period, including delays in planning and implementation, can result in non-compliance and failed evaluations. 

Navigating the complexities of IVD performance evaluation under the IVDR requires thorough planning, adequate resource allocation, comprehensive training, and continuous engagement with specialist external consultants and industry experts.

Understanding the importance of performance evaluations and recognizing common pitfalls can help organisations achieve compliance and ensure the highest standards of patient care and safety.

Join our new training courses, ‘Introduction to the New Performance Evaluation Requirements Mandated Under the IVDR (2017/746)’ and ‘Deep dive into the IVDR Annex XIII’ to learn more about common pitfalls and their solutions in passing Notified Body performance evaluations under the IVDR. Gain detailed knowledge, understanding and expertise within the heavily updated area of performance evaluation within this vital new regulation and explore the opportunities and threats it presents for your business, with input from industry experts.

References:

Amini-Nejad, E. (2021). 2 of The Most Common IVDR Challenges (With Solutions), Med Device Online. [Online] Available at: https://www.meddeviceonline.com/doc/of-the-most-common-ivdr-challenges-with-solutions-0001 (Accessed: 23 May 2024)

Published on Jul 11, 2024 by Jane Leadsham