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Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices

The proposals in this consultation document are just one element of the government’s focus on patient safety.

Since the current regulatory framework was introduced, medical technology has advanced significantly, for instance the growth in the use of advanced diagnostics and digital health products involving software and AI, dramatically transforming the quality of care for patients.

 

Medical Devices Regulations: Routes to market and in vitro diagnostic devices

News & Trends

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Recentes

  • EMA Updates Guidance on National Pharmacovigilance Contact Person Requirements
  • ICH E20 draft guideline on adaptive designs in confirmatory clinical trials
  • Critical shortages of medicines. European Court of Auditors’ Special Report
  • EDQM publishes new guidelines on the classification of active pharmaceutical substances as regards their supply
  • Clinical Evidence Requirements under the EU In Vitro Diagnostics Regulation (IVDR). MEDTECH E-BOOK
  • A Formiventos está novamente no ranking das Top 5% melhores PME de Portugal
  • Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices Version 4 – September 2025
  • ICH adopts M14 guideline on observational studies

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