EMA Expresses Gratitude for New MDR/IVDR Standardization Request, Announces Changes to Deadlines
The European Commission recently adopted a new version of the medical device and diagnostics standardization request, adding more standards and extending deadlines by four years. Harmonized standards are published in the European Union’s Official Journal and provide conformity with essential requirements of regulations. European standards organizations, such as CEN and Cenelec, are responsible for developing […]