Medical Devices (Amendment) Regulations, 2007

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 18,067, 20 ta’ April, 2007

L.N. 113 of 2007

PRODUCT SAFETY ACT

(CAP. 427)

Medical Devices (Amendment) Regulations, 2007

IN exercise of the powers conferred by articles 38 to 40 of the

Product Safety Act, 2001, the Minister for Competitiveness and

Communications, on the advice of the Malta Standards Authority, has

made the following regulations>–

(1) The title of these regulations is Medical Devices Citation and

commencement.

(Amendment) Regulations, 2007, and they shall be read and construed

as one with the Medical Devices Regulations, 2003, hereinafter referred L.N. 47 of 2003.

to as “the principal regulations”.

(2) These regulations transpose Directive 2005#50#EC 1 of

th

11 August, 2005 on the reclassification of hip, knee and shoulder joint

replacements in the framework of Council Directive 93#42#EEC 2

concerning medical devices.

(3) These regulations shall come into force on 1 st September,

2007.

Immediately after regulation 1.2.4 of the principal regulations, Amends regulation

1 of the principal

there shall be inserted the following regulations>

regulations.

“1.2.5. Hip, knee and shoulder replacements that have been

subject to a conformity assessment procedure pursuant to regulation

3(a) of these regulations before 1 st September, 2007, shall be

subject to a complementary conformity assessment under point 4

of Schedule II to these regulations leading to an EC design

examination certificate before 1 st September, 2009.

OJ No. L210, 12-08-2005, p. 41-43.

OJ No. L210, 12-08-2005, p. 41.

(a) This provision does not preclude a manufacturer

from submitting an application for conformity assessment

based on regulation 8.1(b) of these regulations.

1.2.6. Hip, knee and shoulder replacements that have been

subject to a conformity assessment procedure pursuant to regulation

8.3(b)(iii) of these regulations before 1 st September, 2007, shall be

subject to a conformity assessment as class III medical devices

pursuant to regulation 8.1(b)(i) or (ii) of these regulations before

1 st September, 2010.

(a) This provision does not preclude a manufacturer

from submitting an application for conformity assessment

based on regulation 8.1(a) of these regulations.

1.2.7. The placing on the market and the putting into service

of hip, knee and shoulder replacements covered by the decision of

the notified body issued in accordance with section 3.3 or 3.4 of

Annex II of the Directive, which is set out in Schedule II to these

regulations before 1 st September, 2007, shall be accepted until 1 st

September, 2009.

1.2.8. The placing on the market of hip, knee and shoulder

replacements which are covered by the decision of the notified

body issued in accordance with section 3.3 or 3.4 of Annex VI of

the Directive, which is set out in Schedule VI to these regulations

before 1 st September, 2007 shall be accepted until 1 st September,

2010 and permitted to be put into service beyond this date.”.

3. (1) For regulation 2.1.3 of the principal regulations, there

shall be substituted the following>

“2.1.3. Devices shall be divided into Classes I, IIa, IIb and

III. Classification shall be carried out in accordance with Annex

IX of the Directive, which is set out in Schedule IX to these

regulations.

2.1.3.1. By way of derogation from the rules set out in Annex

IX of the Directive, which is set out in Schedule IX to these

regulations, breast implants and hip, knee and shoulder joint

replacements shall be reclassified as medical devices falling within

Class III.”.

4. (1) Immediately after regulation 3.1.34 of the principal Amends

3 of the principal

regulations, there shall be inserted the following>

regulations.

“3.1.35. “Hip, knee or shoulder replacement” means an

implantable component part of a total joint replacement system

which is intended to provide a function similar to that of either a

natural hip joint, a natural knee joint or a natural shoulder joint.

Ancillary components (screws, wedges, plates and instruments)

are excluded from this definition.”.

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