Medical device updates: MDEL modernization, Class III & IV licence applications, and MDD performance reports

As we previously reported, Health Canada announced that the Phase II amendments to the Medical Devices Regulations (MDR) regarding medical device establishment licences (MDELs) will come into force December 14, 2026. Updated guidance documents regarding MDELs (linked here) will also come into force on the same date.... By: Smart & Biggar