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Global Medical Device Regulatory, Reimbursement, and Policy Review


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Latest from Market Pathways

Global Medical Device Regulatory, Reimbursement, and Policy Review

Regulatory & Reimbursement

Pathways Picks October 6: Classification Insights From the US and EU, and China Stays Active

In this week’s roundup: On the same day, the European Commission and FDA separately released important documents addressing fundamental medical device risk-classification processes; China continues its very active streak of policymaking as it continues to ramp up regulatory reform implementation; EUDAMED slowly expands; and more global medtech policy insights.

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Latest from Market Pathways

Global Medical Device Regulatory, Reimbursement, and Policy Review


Regulatory & Reimbursement

FDA Third Party Review Program Tries to Find Its Way

The program allowing device firms to contract with accredited bodies to review 510(k)s has yet to gain real momentum after 24 years. But FDA says its recent efforts to improve the quality of third-party reviews is having an impact and that the framework is an important underpinning of its global harmonization vision. The leading third-party review firm, meanwhile, acknowledges business is slow, but she is committed to expanding the program.

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On to the IVDR: A Paradigm Shift in Diagnostics Regulation is Coming, Ready or Not

Set to take effect in May 2022, the EU IVD Regulation has played second fiddle to the Medical Device Regulation in terms of public focus. But no more. The transition challenge is in many ways steeper for IVDR than it is for MDR, and anxiety levels about system readiness are intensifying. IVDR represents a paradigm shift for diagnostics makers in terms of data and process expectations in Europe. Here’s a look at where things stand and what to expect.

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