The Med­ical Device Coor­di­na­tion Group (MDCG) has pub­lished MDCG 2022-5, Guid­ance on bor­der­line between med­ical devices and med­i­c­i­nal prod­ucts under Reg­u­la­tion (EU) 2017/745 on med­ical devices.

We high­ly rec­om­mend to care­ful­ly review the doc­u­ment if rel­e­vant. MDCG 2022-5 advis­es how to delin­eate between med­ical devices and med­i­c­i­nal prod­ucts in sce­nar­ios where med­i­c­i­nal prod­ucts, herbal prod­ucts, sub­stance-based med­ical devices and com­bi­na­tion prod­ucts are involved. 

The doc­u­ment pro­vides clar­i­fi­ca­tion, exam­ples and flow­charts that are intend­ed to estab­lish a reg­u­la­to­ry ratio­nale for these com­plex products.

Please let us know should you require the guid­ance doc­u­ment. We will be hap­py to send.

Source: MDCG

For fur­ther infor­ma­tion on this sub­ject please browse our web­site by key­word MDCG.