U.S., EU medical device associations push ‘regulatory cooperation’

Medtech industry advocacy groups on both sides of the Atlantic are pushing for regulatory cooperation in the Transatlantic Trade and Investment partnership, which is entering its 3rd year of negotiations.

The groups, represented by AdvaMed, COCIR, EDMA, Eucomed and MITA, hit on 3 priority areas for medical device regulation cooperation.

The combined entities are calling for “a single audit for medical device quality management systems”, “harmonized implementation of unique device identification” and “a single unified format and structure that enables simultaneous product submissions,” according to a press release from AdvaMed. In each area, the combined groups outlined specific objectives.

The groups are pushing for the full implementation of a Medical Device Single Audit Program, developed by the International Medical Device Regulators Forum in hopes of conserving regulatory resources and reducing industry costs.

UDI implementation was touched on, with the hope that the system would enable effective regulatory data exchange and help simplify related regulatory processes.

Finally, implementation of a “single unified format and structure” for Regulated Product Submissions were laid out, to enable the simultaneous submission to multiple regulators electronically to improve efficiency and reduce the time it takes to get products to market.

The combined groups said that cooperation in all 3 areas “embodies the core regulatory principles of the T-TIP” for medtech by streamlining regulatory practices and converging systems to benefit patients and industry companies.

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