Scope of Revisions Until draft regulations are published, the complete scope of the EU revisions

Scope of Revisions

Until draft regulations are published, the complete scope of the EU revisions remains unknown. And, one can only prognosticate. Sources have suggested, though, that the following previously unregulated products will fall under the new regulation’s requirements: products incorporating non-viable human tissues or cells; aesthetic products; in-house laboratory tests; genetic tests for the purpose of diagnosis; and diagnostic services involving assessments performed outside EU borders.

Minor also reiterated during her RAPS presentation the areas of the EU medical device regulatory process that have been targeted for improvement.

These include:

• Improved and more consistent oversight of Notified Bodies;

• More consistent requirements for clinical investigations;

• Boosting post-marketing safety efforts;

• Improving regulatory and market transparency within the process;

• Centralized agency for review ofcertain medical devices;

• Making public some information in the Eudamed medical device database; and

• Making greater use of Unique Device Identifiers (UDI).