PART IIntroductory Provisions Relating to all Medical Devices
F1Revocations, transitional and saving provisions in respect of the new national registration requirements4D
1
Regulation 19 is revoked on the day that is 4 months after IP completion day (which is when regulation 7A comes into force).
2
Regulation 7A does not apply until the day that is 8 months after IP completion day in respect of a device or accessory—
a
that is a relevant device for the purposes of Part II; and
b
that is classified as belonging to—
i
Class IIa, as referred to in regulation 7, or
ii
Class IIb, as referred to in regulation 7, and is also a Group A device (within the meaning given in regulation 52(1)).
3
Regulation 7A does not apply until the day that is 12 months after IP completion day in respect of a device or accessory—
a
that is a relevant device for the purposes of Part II; and
b
that is classified as belonging to Class I, as referred to in regulation 7.
4
Where regulation 7A does not apply in respect of a device or accessory by virtue of paragraph (2) or (3), regulation 19 continues to have effect after its revocation in respect of that device or accessory.
6
Regulation 30(3) is revoked on the day that is 4 months after IP completion day (which is when regulation 21A comes into force).
8
Regulation 44 is revoked on the day that is 4 months after IP completion day (which is when regulation 33A comes into force).
9
Regulation 33A does not apply until the day that is 8 months after IP completion day in respect of a device or accessory—
a
that is a relevant device for the purposes of Part IV, or
b
that is—
i
referred to in List B, mentioned in regulation 40(4), or
ii
a device for self-testing (as defined in relation 32(1)).
10
Regulation 33A does not apply until the day that is 12 months after IP completion day in respect of a device or accessory that is a relevant device for the purposes of Part IV which follows the procedure in regulation 40(1).
11
Where regulation 33A does not apply in respect of a device or accessory by virtue of paragraph (9), regulation 44 continues to have effect after its revocation in respect of that device or accessory.