ln_2020_318

In Vitro Diagnostic Medical Devices (Amendment) Regulations,

18 Articles / Provisions · Malta

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Table of Provisions (18)

Statutory Text (18 Articles)

Malta Government Gazette — Legal Notice 2020 318 · Gazzetta tal-Gvern ta’ Malta Nru. 20,454 - 04.08.2020<P Class=Msonormal — In Vitro Diagnostic Medical Devices (Amendment) Regulations,

Preamble — In Vitro Diagnostic Medical Devices (Amendment) Regulations, Open official source

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 20,454, 4 ta’ Awwissu, 2020

L.N. 318 of 2020

MEDICINES ACT

(CAP. 458)

In Vitro Diagnostic Medical Devices (Amendment) Regulations,

IN EXERCISE of the powers conferred by article 106 of the

Medicines Act, the Minister for Health, after consultation with the

Licensing Authority, has made the following regulations:-

Malta Government Gazette — Legal Notice 2020 318 · Gazzetta tal-Gvern ta’ Malta Nru. 20,454 - 04.08.2020<P Class=Msonormal — In Vitro Diagnostic Medical Devices (Amendment) Regulations,

Reg. 1 — In Vitro Diagnostic Medical Devices (Amendment) Regulations, Open official source

The title of these regulations is the In Vitro Diagnostic Citation.

Medical Devices (Amendment) Regulations, 2020 and these

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

Diagnostic Medical Devices Regulations, hereinafter referred to as the

" principal regulations".

Malta Government Gazette — Legal Notice 2020 318 · Gazzetta tal-Gvern ta’ Malta Nru. 20,454 - 04.08.2020<P Class=Msonormal — In Vitro Diagnostic Medical Devices (Amendment) Regulations,

Reg. 2 — In Vitro Diagnostic Medical Devices (Amendment) Regulations, Open official source

The proviso to sub-regulation 1.2 of the principal Amends

regulation 1.2 of

regulations shall be deleted.

the principal

regulations.

Malta Government Gazette — Legal Notice 2020 318 · Gazzetta tal-Gvern ta’ Malta Nru. 20,454 - 04.08.2020<P Class=Msonormal — In Vitro Diagnostic Medical Devices (Amendment) Regulations,

Reg. 3 — In Vitro Diagnostic Medical Devices (Amendment) Regulations, Open official source

(1) Regulations 3.1.9, 3.1.10, 3.1.11, 3.1.12, 3.1.13, Adds new

3.1.14, 3.1.14.1, 3.1.14.2, 3.1.14.3, 3.1.14.4, 3.1.15, 3.1.15.1, 3.1.16, regulation

principal

3.1.17, 3.1.18, 3.1.19, 3.1.20, 3.1.21, 3.1.22, 3.1.23, 3.1.24, 3.1.25.1, regulations.

3.1.25.2, 3.1.25.3 and 3.1.26 of the Regulations shall be numbered as

3.1.10, 3.1.11, 3.1.12, 3.1.13, 3.1.14, 3.1.15, 3.1.15.1, 3.1.15.2,

3.1.15.3, 3.1.15.4, 3.1.16, 3.1.16.1, 3.1.17, 3.1.18, 3.1.19, 3.1.20,

3.1.21, 3.1.22, 3.1.23, 3.1.24, 3.1.25, 3.1.26, 3.1.26.1, 3.1.26.2,

3.1.26.3 and 3.1.27 respectively; and

(2) Immediately after regulation 3.1.8.2 of the principal

regulations there shall be added the following new regulation 3.1.9

"3.1.9. "Medicines Authority" means the Authority as

established under article 4 of the Medicines Act;".

Malta Government Gazette — Legal Notice 2020 318 · Gazzetta tal-Gvern ta’ Malta Nru. 20,454 - 04.08.2020<P Class=Msonormal — In Vitro Diagnostic Medical Devices (Amendment) Regulations,

Reg. 4 — In Vitro Diagnostic Medical Devices (Amendment) Regulations, Open official source

In regulation 8.1 of the principal regulations, the words Amends

"Director of Consumer Affairs" shall be substituted by the words regulation

the principal

"Medicines Authority".

regulations.

Malta Government Gazette — Legal Notice 2020 318 · Gazzetta tal-Gvern ta’ Malta Nru. 20,454 - 04.08.2020<P Class=Msonormal — In Vitro Diagnostic Medical Devices (Amendment) Regulations,

Reg. 5 — In Vitro Diagnostic Medical Devices (Amendment) Regulations, Open official source

Regulation 8.1.1 of the principal regulations shall be Amends

regulation 8.1.1

substituted by the following new regulation

of the principal

regulations.

"8.1.1The Medicines Authority shall immediately inform

Commission of any such measures, indicating the reasons for the

decision and in particular, whether non-compliance is due to:".

Malta Government Gazette — Legal Notice 2020 318 · Gazzetta tal-Gvern ta’ Malta Nru. 20,454 - 04.08.2020<P Class=Msonormal — In Vitro Diagnostic Medical Devices (Amendment) Regulations,

Reg. 6 Amends regulation 8.2 of the principal regulations. — In Vitro Diagnostic Medical Devices (Amendment) Regulations, Open official source

In regulation 8.2 of the principal regulations shall be

substituted by the following new regulation

"8.2. Where a non-complying medical device referred to

in regulation 3 bears the CE marking, the Medicines Authority

shall take appropriate action against whomsoever has affixed the

marking or drawn the declaration and shall so inform the

Commission and the other Member States thereof.".

Malta Government Gazette — Legal Notice 2020 318 · Gazzetta tal-Gvern ta’ Malta Nru. 20,454 - 04.08.2020<P Class=Msonormal — In Vitro Diagnostic Medical Devices (Amendment) Regulations,

Reg. 7 Amends regulation 8.4 of the principal regulations, — In Vitro Diagnostic Medical Devices (Amendment) Regulations, Open official source

In regulation 8.4 of the principal regulations, the words

"Director of Consumer Affairs" shall be substituted by the words

"Medicines Authority".

Malta Government Gazette — Legal Notice 2020 318 · Gazzetta tal-Gvern ta’ Malta Nru. 20,454 - 04.08.2020<P Class=Msonormal — In Vitro Diagnostic Medical Devices (Amendment) Regulations,

Reg. 8 Amends regulation 8.5 of the principal regulations. — In Vitro Diagnostic Medical Devices (Amendment) Regulations, Open official source

In regulation 8.5 of the principal regulations, the words

"Consumer and Industrial Goods Directorate of the Malta Standards

Authority" shall be substituted by the words "Medicines Authority".

Malta Government Gazette — Legal Notice 2020 318 · Gazzetta tal-Gvern ta’ Malta Nru. 20,454 - 04.08.2020<P Class=Msonormal — In Vitro Diagnostic Medical Devices (Amendment) Regulations,

Reg. 9 Amends regulation 9.1 of the principal regulations. — In Vitro Diagnostic Medical Devices (Amendment) Regulations, Open official source

In regulation 9.1 of the principal regulations, the words

"Consumer and Industrial Goods Directorate of the Malta Standards

Authority" shall be substituted by the words "Medicines Authority".

Malta Government Gazette — Legal Notice 2020 318 · Gazzetta tal-Gvern ta’ Malta Nru. 20,454 - 04.08.2020<P Class=Msonormal — In Vitro Diagnostic Medical Devices (Amendment) Regulations,

Reg. 10 Amends regulation 9.2 of the principal regulations. — In Vitro Diagnostic Medical Devices (Amendment) Regulations, Open official source

In regulation 9.2 of the principal regulations, the words

"Consumer and Industrial Goods Directorate of the Malta Standards

Authority" shall be substituted by the words "Medicines Authority".

Malta Government Gazette — Legal Notice 2020 318 · Gazzetta tal-Gvern ta’ Malta Nru. 20,454 - 04.08.2020<P Class=Msonormal — In Vitro Diagnostic Medical Devices (Amendment) Regulations,

Reg. 11 Amends regulation 9.3 of the principal regulations. — In Vitro Diagnostic Medical Devices (Amendment) Regulations, Open official source

In regulation 9.3 of the principal regulations, the words

"Consumer and Industrial Goods Directorate of the Malta Standards

Authority" shall be substituted by the words "Medicines Authority".

Malta Government Gazette — Legal Notice 2020 318 · Gazzetta tal-Gvern ta’ Malta Nru. 20,454 - 04.08.2020<P Class=Msonormal — In Vitro Diagnostic Medical Devices (Amendment) Regulations,

Reg. 12 Amends regulation 10.1 of the principal regulations. — In Vitro Diagnostic Medical Devices (Amendment) Regulations, Open official source

In regulation 10.1 of the principal regulations, the words

"Director of Consumer Affairs" shall be substituted by the words

"Medicines Authority".

Malta Government Gazette — Legal Notice 2020 318 · Gazzetta tal-Gvern ta’ Malta Nru. 20,454 - 04.08.2020<P Class=Msonormal — In Vitro Diagnostic Medical Devices (Amendment) Regulations,

Reg. 13 Amends regulation 10.3 of the principal regulations. — In Vitro Diagnostic Medical Devices (Amendment) Regulations, Open official source

Regulation 10.3 of the principal regulations shall be

substituted by the following new regulation

"10.3. After carrying out an assessment, if possible together

with the manufacturer, the Medicines Authority shall, without

prejudice to Article 8, immediately inform the Commission and

the other Member States of the incidents referred to in regulation

10.1 for which appropriate measures, including possible

withdrawal, have been taken or are contemplated.".

Malta Government Gazette — Legal Notice 2020 318 · Gazzetta tal-Gvern ta’ Malta Nru. 20,454 - 04.08.2020<P Class=Msonormal — In Vitro Diagnostic Medical Devices (Amendment) Regulations,

Reg. 14 Amends regulation 10.4 of the principal regulations. — In Vitro Diagnostic Medical Devices (Amendment) Regulations, Open official source

In regulation 10.4 of the principal regulations, the words

"Consumer and Industrial Goods Directorate" shall be substituted by

the words "Medicines Authority".

Malta Government Gazette — Legal Notice 2020 318 · Gazzetta tal-Gvern ta’ Malta Nru. 20,454 - 04.08.2020<P Class=Msonormal — In Vitro Diagnostic Medical Devices (Amendment) Regulations,

Reg. 15 Amends regulation 10.5 of the principal regulations. — In Vitro Diagnostic Medical Devices (Amendment) Regulations, Open official source

In regulation 10.5 of the principal regulations, the words

"Consumer and Industrial Goods Directorate" shall be substituted by

the words "Medicines Authority".

Malta Government Gazette — Legal Notice 2020 318 · Gazzetta tal-Gvern ta’ Malta Nru. 20,454 - 04.08.2020<P Class=Msonormal — In Vitro Diagnostic Medical Devices (Amendment) Regulations,

Reg. 16 — In Vitro Diagnostic Medical Devices (Amendment) Regulations, Open official source

In regulation 11.6.1 of the principal regulations, the words Amends

"Director of Consumer Affairs" shall be substituted by the words regulation

11.6.1 of the

"Medicines Authority".

principal

regulations.

Malta Government Gazette — Legal Notice 2020 318 · Gazzetta tal-Gvern ta’ Malta Nru. 20,454 - 04.08.2020<P Class=Msonormal — In Vitro Diagnostic Medical Devices (Amendment) Regulations,

Reg. 17 — In Vitro Diagnostic Medical Devices (Amendment) Regulations, Open official source

In regulation 11.6.2 of the principal regulations, the words Amends

"Director of Consumer Affairs" shall be substituted by the words regulation

11.6.2 of the

"Medicines Authority".

principal

regulations.

€0.18

In Vitro Diagnostic Medical Devices (Amendment) Regulations,

Table of Provisions (18)

Statutory Text (18 Articles)

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