Insights from the 6th Notified Bodies Survey on MDR/IVDR Certifications and Applications

Key Points:

·         Conducted in November 2023, achieving 100% response, the survey reflects trends in certifications under the MDR and IVDR, addressing application volumes, issuance rates, and compliance hurdles.

·         It underscores an upward trend in MDR applications and certifications, with SMEs significantly engaged. Transition dynamics from MDD/AIMDD to MDR and IVDD to IVDR are also discussed.

·         Details on notified bodies' staffing reveal a strategic allocation towards conformity assessments and administrative functions, crucial for understanding the regulatory landscape's operational facets.

🔗 Original: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf