Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:5:p29
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 5 (pt 29/30)
Character Range: 209172–211800

mesh); and
 (d) the person has not withdrawn that application before 1 December 2021; and
 (e) that application has not lapsed under section 41EG of the Act before 1 December 2021; and
 (f) if the conformity assessment certificate was issued before 1 December 2021—the period of 6 months beginning on the day of the issue of the certificate has not ended before 1 December 2021.
 (4B) For the purposes of subregulation (4A), the day applicable under this subregulation is the later of 1 December 2021 and the day after the earliest of the following days:
 (a) the day the person withdraws the application mentioned in paragraph (4A)(c);
 (b) the day that application lapses under section 41EG of the Act;
 (c) in the case of a decision to refuse to issue the conformity assessment certificate and where there is no longer any possibility of a change in the outcome of that decision—the first day on which there is no longer that possibility;
 (d) if the conformity assessment certificate was issued:
 (i) if, at the end of the period of 6 months beginning on the day of the issue of the certificate, the person has not made an application under the Act to have the kind of medical device referred to in paragraph (4A)(c) included in the Register—the last day of that 6‑month period; or
 (ii) if, before the end of the period of 6 months beginning on the day of the issue of the certificate, the person has made an application under the Act to have the kind of medical device referred to in paragraph (4A)(c) included in the Register—the relevant day under subregulation (4C).
 (4C) For the purposes of subparagraph (4B)(d)(ii), the relevant day is:
 (a) the day the person withdraws the application mentioned in that subparagraph; or
 (b) the day that application lapses under section 41FK of the Act; or
 (c) the day on which that application is finally determined;
whichever occurs first.
 (5) For the purposes of this regulation, an application is finally determined at the first time both the following conditions are met:
 (a) a decision has been made whether or not to grant the application;
 (b) there is no longer any possibility of a change in the outcome of the decision.

11.31  Patient information—application of amendments

Devices other than urogynaecological mesh
 (1) The amendments made by Part 2 of Schedule 1 to the amending regulations apply on and after the day mentioned in column 1 of an item of the following table:
 (a) to the extent that the amendments relate to a patient implant card or patient information leaflet mentioned in column 2 of the item; and
 (b) in relation to:
 (i) an application for a