After the May 2017 release, manufacturers have three and five years to comply with MDR and IVDR respectively
Are you prepared to meet the new regulations?
Read the Getting Ready for Europe’s New Rules: A Guide for Successfully Developing and Commercialising Medical Devices and In-Vitro Diagnostics under MDR and IVDR white paper to learn how to effectively prepare for these imminent regulatory changes, including:
- Elevated Clinical Requirements - How will enhanced clinical reporting requirements under the new regulations, necessitating both pre-certification clinical assessments and post-market monitoring, impact the product life cycle?
- Reclassified and Up-Classified Devices - Discover which medical devices will move to higher classifications and how the notified body certification requirement will impact the product development of up to 90% of IVDs.
- A New Role for Notified Bodies - Find out the repercussions of the new associated designation requirements for the Notified Bodies on your development process.