- Replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC)
- 3 year transition period in effect until May 2021 for manufacturers who currently sell CE marked devices in the EU. (See note below)
- Beefed up requirements for post-market surveillance, labeling, clinical evaluations (list is not all-inclusive). New requirements including economic operators and contents of technical documentation, regulatory plan.
- Essential Requirements in 93/42 EEC and 90/385/EEC have been replaced with General Safety and Performance Requirements (GSPRs)
NOTE: Due to the COVID-19 pandemic, DoA (Date of Application) for EU MDR has been delayed to May 26, 2021. Please note: This does not mean that all requirements have been pushed back accordingly.