PART IIGeneral Medical Devices
F1Obligations in Part II and III of these Regulations which are met by complying with obligations in Regulation (EU) 2017/74519C
1
In this regulation—
a
“the Regulation” means Regulation (EU) 2017/745, as it has effect in EU law, and any reference to an Article or an Annex is a reference to an Article or Annex of the Regulation;
b
“CE marking” means the CE marking required by Article 20 and presented in Annex V;
c
“harmonised standard” has the meaning given in Article 2(70);
d
“sponsor” has the meaning given in Article 2(49).
2
Where paragraph (3) applies, regulations 8, 10(1) to (4), 11, 13, 22, 23, 24 and 27 are treated as being satisfied.
3
This paragraph applies where, before placing a relevant device within the meaning of Part II or Part III (as the case may be) other than a system or procedure pack, a custom-made device or a device intended for clinical investigation on the market, the manufacturer—
a
ensures—
i
that the device meets the general safety and performance requirements in Annex I which apply to it; or
ii
that paragraphs (10) and (11) apply;
b
ensures that the relevant conformity assessment procedure that applies to the device has been carried out in accordance with Article 52;
F2ba
ensures that any certificate issued by a notified body in connection with that conformity assessment procedure has not expired or been withdrawn;
c
ensures that the documentation required by the relevant conformity assessment procedure is drawn up;
d
ensures that the technical documentation required by Annexes II and III and other relevant documentation required by a relevant conformity assessment procedure is prepared in or translated into English;
e
affixes a CE marking and, where applicable, the identification number of the notified body which carried out the relevant conformity assessment on the device in accordance with the procedure set out in Annexes IX, X or XI;
f
draws up an EU declaration of conformity in accordance with Article 19;
g
ensures that the declaration of conformity is prepared in or translated into English.
4
Where paragraph (5) applies regulations 8 and 15 (or as the case may be) 22 and 28 are treated as being satisfied.
5
This paragraph applies where, before a custom-made device is placed on the market, the manufacturer—
a
has drawn up a statement in English containing the information specified in Section 1 of Annex XIII;
b
has undertaken to keep available to the Secretary of State (notwithstanding that the Secretary of State is not a competent national authority) documentation allowing for an understanding of the design, manufacture and performance of the device, including the expected performances, so as to allow assessment of the conformity of the device with the requirements of the Regulation; and
c
undertakes to comply with Sections 3 (manufacturing), 4 (retention of information) and 5 (review of experience) of Annex XIII.
6
Where paragraph (7) applies, regulations 8 and 14 are treated as being satisfied.
F37
This paragraph applies where, before a system or procedure pack is placed on the market, the person responsible for combining devices to produce that system or procedure pack—
a
has complied with the relevant requirements of Article 22 including where that Article requires a conformity assessment in accordance with Annex IX or XI; and
b
ensures that any certificate issued by a notified body in connection with that conformity assessment procedure has not expired or been withdrawn.
8
Where paragraph (9) applies, regulations 8 and 16(1) or (as the case may be) 22 and 29(1) are treated as being satisfied.
9
This paragraph applies where, before a relevant device intended for clinical investigation is made available in Great Britain for the purpose of a clinical investigation, the manufacturer—
a
has provided the Secretary of State with the required notice in the form of the application required by Article 70 in English; and
b
has provided the Secretary of State with an undertaking to keep available documentation contained in the application in accordance with Section 3 of Chapter III of Annex XV.
10
Where paragraph (11) applies, a relevant device referred to in that paragraph is also treated as complying with the relevant essential requirement referred to in regulation 9(4) or regulation 23(4) (as the case may be).
11
This paragraph applies where a relevant device conforms with a harmonised standard or part of a harmonised standard, which corresponds exactly to a designated standard or part of a designated standard.
12
For the purpose of this regulation in regulations 10(5), 51 and 61(8), each reference to “UK marking” is to be read as a reference to “CE marking”.