The Euro­pean Commission’s lat­est Man­u­al on Bor­der­line and Clas­si­fi­ca­tion clar­i­fies how to assess when a prod­uct falls under the Med­ical Devices Reg­u­la­tion or In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion or none of both. It con­sol­i­dates deci­sions by the Med­ical Device Coor­di­na­tion Group’s Bor­der­line & Clas­si­fi­ca­tion Work­ing Group (BCWG), espe­cial­ly those resolved via the Helsin­ki Procedure. 

The Man­u­al offers worked exam­ples of “bor­der­line” cases—such as devices strad­dling med­ical vs. acces­so­ry, med­i­c­i­nal prod­uct, gen­er­al equip­ment, or soft­ware categories—and guid­ance on apply­ing risk-clas­si­fi­ca­tion rules. While not legal­ly bind­ing, it serves as a har­monised ref­er­ence to sup­port con­sis­tent reg­u­la­to­ry decisions.

The doc­u­ment can be down­loaded in our Down­load sec­tion or direct­ly here.

Source: Euro­pean Commission 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website