Regulation 4 Amendment of Part II of the 2002 Regulations

Part II of the 2002 Regulations is amended as follows.

In regulation 6 (Scope of Part II) after paragraph (c) insert—

“(d)

except for the requirement to register under regulation 7A or 19, medical devices or accessories to such devices placed on the market in accordance with Part VIII.”.

In regulation 7 (Classification of general medical devices), omit paragraph (2).

After regulation 7 insert—

“Registration of persons placing general medical devices on the market

7A.

(1)

No person may place a relevant device on the market in accordance with this Part (or Part VIII insofar as it applies to relevant devices) unless that person—

(a)

is established in the United Kingdom; and

(b)

has complied with paragraph (2).

(2)

A person complies with this paragraph if, before placing the relevant device on the market, the person—

(a)

informs the Secretary of State of the address of their registered place of business in the United Kingdom or, if the person does not have a registered place of business, an address in the United Kingdom at which service of any document relating in any way to the person’s placing of the relevant device on the market will be effective;

(b)

if they are not the manufacturer of the relevant device, provides the Secretary of State with written evidence that they have the manufacturer’s authority to place the relevant device on the market;

(c)

supplies the Secretary of State with a description of the relevant device; and

(d)

pays to the Secretary of State the relevant fee in accordance with regulation 53.

(3)

Where a person provides the Secretary of State with the written evidence required by paragraph (2)(b), that person is to be regarded as the UK responsible person and that person must—

(a)

ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;

(b)

keep available for inspection by the Secretary of State a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements;

(c)

in response to a request from the Secretary of State, provide the Secretary of State with all the information and documentation necessary to demonstrate the conformity of a device;

(d)

forward to the manufacturer any request by the Secretary of State for samples, or access to a device and ensure that the Secretary of State receives the samples or has been given access to the device;

(e)

cooperate with the Secretary of State on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;

(f)

immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;

(g)

terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations and inform the Secretary of State and, if applicable, the relevant notified body of that termination.

(4)

In this regulation the references to “technical documentation” and “declaration of conformity” are to be construed in accordance with the following—

(a)

where this regulation applies and Part II applies —

(i)

the reference to technical documentation is to be construed in accordance with Annex II, III or VII;

(ii)

the reference to the declaration of conformity is to be construed in accordance with Annexes II, IV, V, VI and VII as applied by regulation 13;

(b)

where this regulation applies and Part VIII applies—

(i)

the reference to technical documentation is to be construed in accordance with Schedules 4 and 5;

(ii)

the reference to the declaration of conformity is to be construed in accordance with regulation 84.”.

In regulation 8 (essential requirements for general medical devices), in paragraph (3), for “Annex I to Directive 2006/42” insert “Part 1 of Schedule 2 to the Supply of Machinery (Safety) Regulations 2008”.

In regulation 9 (determining compliance of general medical devices with relevant essential requirements)—

In regulation 12 (Exemptions from regulations 8 and 10) after paragraph (5) insert—

“(6)

Regulations 8 and 10 do not apply where the Secretary of State directs that a relevant device, or a class of relevant devices, which meets other requirements or standards, or which is marked other than with a CE marking, which the Secretary of State determines is equivalent to the requirements and standards imposed by regulations 8 and 10, may be placed on the market.

(7)

In paragraph (6), the Secretary of State, in determining whether another standard requirement, or marking (“the other standard”) is equivalent to a standard or requirement imposed by regulations 8 and 10, must be satisfied that the other standard imposes a degree of safety and quality equivalent to that imposed by those regulations.”.

In regulation 17^f1 (Manufacturers etc. and conformity assessment procedures for general medical devices), omit paragraph (3).

Omit regulation 18^f2 (UK notified bodies and the conformity assessment procedures for general medical devices).