2019 IMDRF Guidance Changes Related to Clinical Evidence, Evaluation, and Investigations

April 15, 2020

Since the release of the European Medical Device Regulation and MEDDEV 2.7/1 Rev 4, medical device regulatory professionals are craving clarity on issues related to clinical data that supports new global submissions and ongoing regulatory compliance. Late in 2019, the International Medical Device Regulators Forum (IMDRF) issued three updated guidance documents that clear up confusion and harmonize the guidance with the EU MDR.

They include:

  • Clinical Investigation – IMDRF MDCE WG/N57FINAL:2019 (formerly GHTF/SG5/N3:2010)
  • Clinical Evaluation – IMDRF MDCE WG/N56FINAL:2019 (formerly GHTF/SG5/N2R8:2007)
  • Clinical Evidence – IMDRF MDCE WG/N55 FINAL:2019 (formerly GHTF/SG5/N1R8:2007)

Relax – We’ve Researched the Changes for You

If you have tried figuring out what has changed when an updated guidance has been issued, you know it can be maddening. You’re in luck – we did that for you. The links below open the original PDF guidance documents in which we have made notes on what has changed and how it may affect you.

 

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Summary of Changes in IMDRF Clinical Investigation Guidance

Here are some of the changes you’ll find in the updated version of the IMDRF MDCE WG/N57 clinical investigation guidance.

  • Definition of a clinical investigation – On page 4, the definition has been broadened to include an emphasis on “effectiveness.”
  • Risk control measures – New language has been added to emphasize the need to evaluate the overall benefit/risk equation and measure residual risks. This brings the guidance in alignment with the MDR and updated ISO 14971:2019 standard.
  • Considerations for conducting clinical investigations – Page 8 contains a simple but useful new flowchart that helps you decide whether a clinical investigation is needed.
  • Pseudo clinical studies – Page 9 includes new requirements aimed to thwart “studies” intended to gain market access by avoiding regulatory approvals by stating that studies will need to have an actual target completion date and be reported.
  • Higher level of scrutiny for results analysis – New expectations have been added on page 10 that raise the bar for manufacturers to justify, control, plan, and explain statistical results.
  • Fewer protocols by region – Page 10 adds new language that removes the burden of manufacturers having to develop multiple protocols for a specific region.

This is a partial list of changes. See all changes in IMDRF MDCE WG/N57 by downloading this PDF.

Summary of Changes in IMDRF Clinical Evaluation Guidance

Here are some of the changes you’ll find in the updated version of the IMDRF MDCE WG/N56 clinical evaluation guidance.

  • Clinical evaluation is a process, not a project – In keeping with the similar direction outlined in the EU MDR, MEDDEV 2.7-1 rev 4, and ISO 14971:2019, page 4 adds five important words: “…a set of ongoing activities…” to describe clinical evaluation and make it clear that your job is never really done. J
  • Timing of clinical evaluations – Page 4 makes it clear that clinical data should be gathered during the product development phase. The previous version said this should first be conducted during the “conformity assessment process,” which may happen after product development.
  • Not all data is good data – Page 5 notes that manufacturers need to appraise data and rank its importance. In other words: Is the data useful, and does it support device safety, performance, and effectiveness? This last point about the need to evaluate “clinical performance” and “effectiveness” permeates the 2019 version.
  • New/updated reference documents added – Break out the reading glasses, because Section 3.0 on page 6 gives you a lengthy reading list of new and updated reference documents.
  • New and updated definitions – There are too many to outline here but download the PDF to see some important updates and a few new definitions!
  • Finally, SaMD gets some love – The 2019 update recognizes that Software as a Medical Device is not just a fad like the interweb and refers to a related IMDRF document.
  • Disclosure of COI – Regulators added a new clause on page 15 that requires manufacturers to disclose potential conflicts of interest (COI) and relevant financial arrangements.
  • New appendices – Appendix A (page 20) and Appendix D (page 23) are all new.

But wait, there’s more! See a list of all changes in IMDRF MDCE WG/N56 by downloading this PDF.

Summary of Changes in IMDRF Clinical Evidence Guidance

Finally, the IMDRF MDCE WG/N55 guidance updates some key definitions found throughout the other two guidance documents and puts it in line with the EU MDR. While no huge changes occurred here, you’ll want to review the changes to definitions related to clinical investigations (page 5) and clinical evaluations (page 6). There is also a highly relevant addition to section 4.2 you’ll want to read. You can download the annotated PDF here.

Want to Learn More?

If all the recent changes related to medical device clinical data makes you a little dizzy, you’re not alone. Every month dozens of thoroughly confused regulatory professionals take our deep-dive training on clinical evaluation reports and emerge three days later thoroughly unconfused. You can be one of them. Check it out here. Naturally our expert team of clinical and MDR/IVDR consultants are ready to help as well.

 

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