Let’s be honest: the new International Medical Device Regulators Forum (IMDRF) “Playbook for Medical Device Regulatory Reliance Programs” isn’t written for manufacturers, so most in the field probably haven’t read it. But we have, so you don’t have to.

This guide, intended for global regulatory authorities, introduces "regulatory reliance", where a regulator in one country gives significant weight to, or accepts, the assessment already performed by a trusted regulator elsewhere. Instead of starting every device review from scratch, regulators can leverage this work to make faster, more efficient decisions.

Even if you’re not a regulator, you should understand this approach: it shapes device review and approval worldwide. Reliance is meant to benefit the whole medical device ecosystem. For manufacturers, successful reliance programs translate into shorter review times, reduced burdens, and optimized resources, especially vital for small and midsize companies. By understanding how regulators build these programs, you can strategically target “Reference Regulatory Authorities” first, setting off a domino effect for faster approvals in other markets.

Here’s what’s crucial for manufacturers to know from the playbook.

The Core Concept: Working Smarter, Not Harder

Regulatory reliance helps regulators avoid reinventing the wheel. Instead of repeating every device review, they use assessments from trusted partners (“reference RAs”).

The playbook highlights three main types of reliance:

  1. Work-Sharing: Regulators jointly perform a task. The Medical Device Single Audit Program (MDSAP) is the ultimate example here, where a single audit meets requirements for multiple countries.
  2. Abridged Pathways: If a device is approved by a trusted regulator, another may do only a partial review. For example, Singapore’s HSA and Brazil’s ANVISA optimize their reviews by considering reference regulators’ assessments.
  3. Recognition: A regulator accepts another authority’s decision with minimal or no extra review. Australia’s TGA can recognize certain UK authorities’ decisions, for instance. The European single market’s CE mark is another real-world model: approval in one EU nation enables sales across the region with no extra hurdles.
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The “Sameness” Factor

To use fast-track pathways, your device must be “essentially identical” across markets.

The IMDRF urges strict processes to confirm you’re submitting the same device as approved by the reference regulator, same technical specs, use, manufacturing, and safety.

Here’s the pitfall: While the playbook simply asks for proof of this sameness, what actually disqualifies manufacturers in the real world is poor data management. Files with different revision states, copy-paste errors, and outdated records prevent you from proving to regulators that your device matches the version approved elsewhere. Lack of data integrity can null all organizsational benefits reliance programs are supposed to bring.

This is where a digitalization strategy is a major advantage.

Digitizing your technical documentation and moving from disjointed files to structured digital data makes it much easier to prove “sameness.” With a single digital source of truth, you can quickly produce the technical summaries regulators need to confirm identicality between markets or provide the additional documentation needed in case some aspects of the assessments are still different.

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The Takeaway

Regulators are building infrastructure to share data and speed trusted product approvals. By understanding reliance pathways and digitalizing your documentation to integrate with them, you can get your technologies to global markets faster than ever before.