A Changing Landscape
Medical Device (MD) manufacturers are confronted with major changes in the EU’s decades-old relevant regulatory framework. The Medical Device Regulation (MDR) entered into force on May 25th 2017 will progressively replace the EU’s current Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC) until May 26th 2021 and May 2022 respectively.
Get Ready for the New MDR
- Are you fully aware and understand up- coming changes?
- Are you prepared to respond to the new requirements posed by the new MDR?
- What is the best approach for your product to be placed in the market under the new MDR?
- Are you clear on the little classification details that may have a big impact to your business ensuring continued marketability?
- New reporting EUDAMED requirements; Have you assigned the MD “Qualified Person”?
- Are your unique MD identification and labelling procedures aligned with the new provisions?
- Are you ready to comply with the new technical documentation requirements?
- Have you considered assessing your current clinical evaluation adequacy for compliance with the new MDR?
- Have you evaluated the additional clinical data you may require for complying with the new MDR?
- Is your post marketing surveillance activities and PMS Plan adequately prepared as per the new MDR standards?
The deadline is approaching. Remember: All Medical Devices affected; old and new.