IMDRF plans new PCCP guideline, adds new affiliates

The International Medical Device Regulators Forum (IMDRF) agreed to a new draft document on predetermined change control plans (PCCP) and is working to develop guidance on cybersecurity controls following a recent meeting in Hokkaido, Japan. The group also plans to revise 2024 guidance on medical devices and diagnostics labeling and accepted several new affiliate members to its ranks.

During the meeting, the group held panels discussing modernizing conformity assessments and focused on topics including classification approaches, post-market surveillance, and real-world evidence. The regulators also discussed the challenges associated with risk-based classification interpretations across jurisdictions, especially in terms of digital health and in-vitro diagnostics (IVD).

A key outcome of the IDMRF meeting is that the management committee approved a draft document entitled "Essential Principles and Content of Predetermined Change Control Plans" for 60-day public consultation from its Software as a Medical Device Working Group. The working group was tasked with developing the document when IMDRF met in Seattle a year ago.

PCCPs have become a significant subject of interest in the US after Congress gave the Food and Drug Administration (FDA) explicit authority under the 2023 Consolidated Appropriations Act to allow their use. (RELATED: FDA draft guidance allows AI/ML devices to evolve without requiring new submissions, Regulatory Focus 31 March 2023)

PCCPs allow sponsors to make predetermined changes to their product in agreement with regulators without submitting a new application. While the tool has been typically considered for software-based products and artificial intelligence (AI), where change happens extremely fast, it has also been considered for other areas, such as manufacturing processes. (RELATED: FDA official discusses use cases, limits for device PCCPs, Regulatory Focus 26 February 2024)

The IMDRF management committee announced plans to develop a new guidance on cybersecurity controls and testing considerations and a revision to the IMDRF/GRRP WG/N52 guidance on labeling principles for medical devices and IVDs. The committee also approved affiliate memberships for regulators from Colombia, Ghana, Indonesia, and the Philippines.

Additionally, the management committee closed the Regulated Product Submission Working Group but said it would continue to refine and pilot its dynamic template with a small group of regulatory authorities. Furthermore, it said it would update the Non-In Vitro Diagnostic Device Regulatory Submission Table of Contents N9 and In Vitro Diagnostic Device Regulatory Submission Table of Contents N13 documents when necessary.

Finally, the management committee agreed to develop a central repository of training materials on the IMDRF website.

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IMDRF plans new PCCP guideline, adds new affiliates

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