The Medical Devices Introductory Course 2020

Medical Device Regulatory Affairs

Back–Up Information Slides

The Organisation for Professionals in Regulatory Affairs

BREXIT: Potential Implications

• For UK-based Manufacturers: • Set up contract with an EU-27 based Authorised Representative (and add them to the device label) • Transfer to an EU-27 based Notified Body (and change NB number on label) • Consider switching “Manufacturer” location to an EU-27 Member State • May need to identify / contract with an importer within EU-27 • For Manufacturers based outside the UK: • No impact, other than may need to meet new requirements to export to / import into UK, depending on regulatory approach adopted by UK for medical devices – contract with a UK-based Authorised Representative (label change), UK Notified Body? (label change) and may need to add “UK Mark” (TBD). Date of MDR application in UK (v. EU27 Delay)?

• For UK-based Notified Bodies EU REPs: • May need to set up a new NB / EU REP within an EU-27 Member State