Module 15 Presentations

4/15/2024

Great Britain Route to Market (excludes Northern Ireland)

UKCA • New route to market. Will ultimately replace the CE route • UKCA legislation currently based on UK MD law UKMDR2002 • Under revision to create new UKCA legislation more closely aligned to the EU Medical Device Regulation ((EU) 2017/745 or 746) • Expected July 2025 • [If third party conformity assessment is required, manufacturer applies to UKAB and UKCA Certificate Issued] • Manufacturer draws up DoC and applies UKCA mark to devices • Registers with MHRA • Places device on market

CE • Only valid until 30 June 2028/2030 • EU CE mark recognised during transition • EU legislation Medical Device Regulation (EU) 2017/745 or IVD Regulation (EU) 2017/746 • [If third party conformity assessment is required, manufacturer applies to EU NB and EC Certificate Issue] • Manufacturer draws up DoC and applies CE mark to devices • Registers with MHRA • Places device on market

• Note: MDD/AIMD Legacy devices require CE certificate + valid declaration

© NAMSA 2023 | 35

35

The New UK Regulatory System

UKCA

The UK Responsible Person • Required for manufacturers located outside the UK • Appears on labelling of UKCA marked devices • A manufacturer can only appoint 1 UK Responsible Person • Responsibilities include:

• Registration of devices • Ensure DoC and technical file drawn up • Provide information/device samples to MHRA on request • Cooperate with MHRA on CAPAs • Inform manufacturer about complaints/suspected incidents • terminate the relationship if the manufacturer acts contrary to their obligations

36

© NAMSA 2021

36