RE: Visitect Approval18 Jan 2022 19:02
Hi RegulatorUK,
I am trying to understand how yhe regulation flows down. My understanding in that the CDTA requirement are in effect 38 of MDR 2002 and not part of the EU MDR.
The following is off the ukgov website
'All medical devices, including IVDs, custom-made devices and systems or procedure packs must be registered with the MHRA before being placed on the Great Britain market. In Great Britain (England, Wales and Scotland), devices must conform to the UK MDR 2002, the EU MDR (until 30 June 2023), or the EU IVDR (until 30 June 2023) in order to be registered with the MHRA. In addition, devices that have been CE marked under the EU MDD, EU AIMDD or EU IVDD will continue to be accepted on the Great Britain market until 30 June 2023 if their certificates remain valid for the EU market under the transitional arrangements in the EU MDR and EU IVDR.'
How does the CDTA requirement feed into the eu requirements?(or is there something else that calls this out).