European Harmonization: MDR requirements and progress on key standards and labelling
There are 400 standards harmonized under the EU Medical Device Directives (AIMD, MDD and IVDD). When the Directives are replaced by the new Medical Devices and IVD Regulations the standards will no longer provide presumption of conformity to the Regulations.
This webinar will cover the following:
- Status of the transition on harmonized standards
- Standards and Common Specifications
- Proposal for inclusion of new standardized symbols EN ISO 15223
- Brief update on key standards
Please join Paul Sim, Knowledge Solutions - Medical Devices Knowledge Manager, for an insight into these key changes for your business and how you can start preparing now.