Regulations, 2012

Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 18,983, 30 ta’ Ottubru, 2012

L.N. 371 of 2012

PRODUCT SAFETY ACT

(CAP. 427)

In Vitro Diagnostic Medical Devices (Amendment)

Regulations, 2012

IN exercise of the powers conferred by articles 38 and 39 of the

Product Safety Act, the Minister for Fair Competition, Small

Business and Consumers, on the advice of the Malta Competition and

Consumer Affairs Authority, has made the following regulations:-

(1) The title of these regulations is the In Vitro Citation, scope

Diagnostic Medical Devices (Amendment) Regulations, 2012 and and

commencement.

these regulations shall be read and construed as one with the In Vitro S.L. 427.16

Diagnostic Medical Devices, hereinafter referred to as "the principal

regulations".

(2) These regulations aim to transpose Commission Directive

2011/100/EU of 20th December 2011 amending Directive 98/79/EC

of the European Parliament and of the Council on in vitro diagnostic

medical devices.

(3) These regulations shall enter into force on 1st July, 2012.

In List A of Schedule II to the principal regulations, Amends

immediately after the words "HTLV I and II, and hepatitis B, C and ScheduleII

the principal

D", there shall be added the following

regulations.

" -

Variant Creutzfeldt-Jakob disease (vCJD) assays for

blood screening, diagnosis and confirmation".

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