Video: Are you ready for EU MDR 2017/745-746?
The European Regulatory Framework for Medical Device field is changing with the release of the new Regulation. The MDR will replace the existing Directives and it will be fully in force in May 2020.
The specific changes will affect:
- New essential requirements,
- Reclassification for some products
- Clinical evaluation
- Vigilance & post-market surveillance
- Registration through EUDAMED system
- Labelling & the supply chain with the unique device identification (UDI).
Are you ready for this challenge?
PQE Group, thanks to its worldwide leadership in the Medical Device field, can help companies to be ready for this change and support them through all the regulatory steps as well as to ensure compliance with the international standard ISO 13485:2016