# The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2023, Regulation 11: Amendment to regulation 2A (medical devices which are qualifying Northern Ireland goods)


In regulation 2A—
(a) in paragraph (1)—
(i) before “Notwithstanding” insert “Subject to paragraph (1A),”;
(ii) for sub-paragraph (a) substitute—
“(a) which meets the requirements of—
(i) these Regulations as they apply in Northern Ireland;
(ii) Regulation (EU) 2017/745; or
(iii) Regulation (EU) 2017/746; and”;
(b) after paragraph (1) insert—
“(1A) Before 25 July 2024, paragraph (1) only applies to a coronavirus test device that meets the requirements of Regulation (EU) 2017/746 if the device also meets the requirements of—
(a) regulation 34A (approval requirement for coronavirus test devices); or
(b) the common specifications set out in Annex I and XIII to Regulation (EU) 2022/1107.”.

---
Source: https://www.legislation.gov.uk/ukdsi/2023/9780348253696/regulation/11 (the official version)
Page: https://openlegislation.uk/draft-medical-devices-in-vitro-diagnostic-devices-etc-amendment-regulations-2023/regulation-11
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.