UK Medical Devices Regulation Reform

↓ Government response to consultation on proposals to support… ↓ Government response to consultation on proposals to support… (16pp)

↓ Ministerial Foreword ↓ Ministerial Foreword (1pp) ↓ Executive summary ↓ Executive Summary (2pp) ↓ Introduction ↓ Introduction (2pp) ↓ Information for respondents ↓ Information for Respondents (2pp) ↓ Overview of contents ↓ Overview of Contents (7pp) ↓ Medicines and Medical Devices Act 2021 Assessment ↓ Medicines and Medical Devices Act 2021 Assessment (5pp) ↓ Data Protection and Privacy Information ↓ Data Protection and Privacy Information (2pp) ↓ Devices Regulation - Background ↓ Devices Regulation - Background (2pp) ↓ Chapter 1: Scope of the Regulations ↓ Chapter 1: Scope of the Regulations (7pp) ↓ Chapter 2: Classification ↓ Chapter 2: Classification (3pp) ↓ Chapter 3: Economic Operators ↓ Chapter 3: Economic Operators (17pp) ↓ Chapter 4: Registration and UDI ↓ Chapter 4: Registration and UDI (13pp) ↓ Chapter 5: Approved Bodies ↓ Chapter 5: Approved Bodies (7pp) ↓ Chapter 6: Conformity Assessment ↓ Chapter 6: Conformity Assessment (8pp) ↓ Chapter 7: Clinical Investigation / Performance Studies ↓ Chapter 7: Clinical Investigation / Performance Studies (40pp) ↓ Chapter 8: Post-market Surveillance and Vigilance ↓ Chapter 8: Post-market Surveillance and Vigilance (9pp) ↓ Chapter 9: In vitro Diagnostic Medical Devices ↓ Chapter 9: In vitro Diagnostic Medical Devices (5pp) ↓ Chapter 10: Software as a Medical Device ↓ Chapter 10: Software as a Medical Device (6pp) ↓ Chapter 11: Implantable Devices ↓ Chapter 11: Implantable Devices (6pp) ↓ Chapter 12: Other Product-Specific Changes ↓ Chapter 12: Other Product-Specific Changes (7pp) ↓ Chapter 13: Environmental sustainability and public health … ↓ Chapter 13: Environmental sustainability and public health … (3pp) ↓ Chapter 14: Routes to market ↓ Chapter 14: Routes to market (4pp) ↓ Chapter 15: Transitional Arrangements ↓ Chapter 15: Transitional Arrangements (3pp) ↓ Chapter 16: Feedback ↓ Chapter 16: Feedback (1pp) ↓ Chapter 17: Questions for members of the general public ↓ Chapter 17: Questions for members of the general public (12pp) ↓ Appendix (5pp) ↓ Glossary (11pp) ↓ Government response to consultation on the future regulatio… (155pp) ↓ Ministerial Foreword ↓ Executive Summary ↓ Assessment of the requirements under the Medicine and Medic… ↓ Chapter 1 - Scope of the Regulations ↓ Chapter 2 - Classification ↓ Chapter 3 - Economic Operators ↓ Chapter 4 - Registration and UDI ↓ Chapter 5 - Approved Bodies ↓ Chapter 6 - Conformity Assessments ↓ Chapter 7 - Clinical Investigation and Performance Studies ↓ Chapter 8 - Post-market Surveillance, Vigilance, Market Sur… ↓ Chapter 9 - In vitro Diagnostic Medical Devices ↓ Chapter 10 - Software as a Medical Device ↓ Chapter 11 - Implantable Devices ↓ Chapter 12 - Other Product Specific Changes ↓ Chapter 13 - Environmental Sustainability and Public Health… ↓ Chapter 14 - Alternative Routes to Market ↓ Chapter 15 - Transitional Arrangements ↓ Chapter 16 - Feedback