Regulations, 2020

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

L.N. 319 of 2020

MEDICINES ACT

(CAP. 458)

Active Implantable Medical Devices (Amendment)

Regulations, 2020

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:-

The title of these regulations is the Active Implantable Citation.

Medical Devices (Amendment) Regulations, 2020 and these

regulations shall be read and construed as one with the Active S.L. 427.10.

Implantable Medical Devices Regulations hereinafter referred to as the

"principal regulations".

Sub-regulation (2) of regulation 2 of the principal Amends

regulation 2 of

regulations shall be amended as follows

the principal

regulations.

(a) in paragraph (a) thereof, the words "Regulatory

Affairs Directorate" shall be substituted by the words "Medicines

Authority"; and

(b) in paragraph (b) thereof, the words "Regulatory

Affairs Directorate" shall be substituted by the words "Medicines

Authority".

Regulation 3 of the principal regulations shall be amended Amends

regulation 3 of

as follows

the principal

regulations.

(a) the definitions "Market Surveillance Directorate",

"Regulatory Affairs Directorate" and the marginal notes "S.L.

419.03" thereof wherever they occur shall be deleted; and

(b) immediately after the definition "medical device"

there shall be added the following new definition

" "Medicines Authority" means the Authority as

established under article 4 of the Medicines Act;".

Regulation 6 of the principal regulations shall be amended Amends

regulation 6 of

as follows

the principal

regulations.

(a) in sub-regulation (9) thereof, the words "Director of

Regulatory Affairs" shall be substituted by the words "Medicines

Authority"; and

(b) in sub-regulation (10) thereof, the words "Regulatory

Affairs Directorate" shall be substituted by the words "Medicines

Authority".

Regulation 7 of the principal regulations shall be amended

as follows

(a) in sub-regulation (1) thereof, the words "Regulatory

Affairs Directorate" shall be substituted by the words "Medicines

Authority";

(b) in sub-regulation (2) thereof, the words "Regulatory

Affairs Directorate" shall be substituted by the words "Medicines

Authority" wherever they occur;

(c) in sub-regulation (4) thereof, the words "Regulatory

Affairs Directorate" shall be substituted by the words "Medicines

Authority" wherever they occur; and

(d) sub-regulation (5) thereof shall be substituted by the

following new sub-regulation

"(5) The

manufacturer

or

his

authorised

representative shall notify the Medicines Authority and the

competent authorities of the Member States concerned of

the end of the clinical investigation, with a justification in

case of early termination. In the case of early termination of

the clinical investigation on safety grounds this notification

shall be communicated to all Member States and the

Commission. The manufacturer or his authorised

representative shall keep the report referred to in

section2(c)(vii) of Schedule VII at the disposal of the

Medicines Authority and the competent authorities of the

other Member States concerned.".

Regulation 8 of the principal regulations shall be amended

as follows

(a) in sub-regulation (1) thereof shall be substituted by

the following new sub-regulation

"Where it is found that the devices referred to in the

definitions of "active implantable medical device" and

"cusom device", correctly put into service and used in

accordance with their intended purpose, may compromise

the health and, or safety of patients, users or, where

applicable, other persons, all appropriate measures shall be

taken by the Medicines Authority to withdraw such devices

from the market or prohibit or restrict their being placed on

the market or their being put into service.

The Medicines Authority shall immediately

inform the Commission of any such measure, indicating the

reasons for such decisions and, in particular, whether non-

compliance with these regulations is due to

(a) failure to meet the essential requirements

referred to in regulation 5(1), where the device does

not meet in full or in part the standards referred to in

regulation 5(7);

(b)

incorrect application of those standards;

(c) shortcomings

in

the

standards

themselves.";

(b) sub-regulation (2) thereof shall be substituted by the

following new sub-regulation

"(2) Where a device which does not comply bears

the CE marking, the Medicines Authority shall take

appropriate action against whomsoever has affixed the

mark. The Medicines Authority shall inform the

Commission and other Member States of such actions.";

(c) in sub-regulation (3) thereof, the words "Market

Surveillance Directorate and the Regulatory Affairs Directorate"

shall be substituted by the words "Medicines Authority";

(d) in sub-regulation (5) thereof, the words "Regulatory

Affairs Directorate" shall be substituted by the words "Medicines

Authority" wherever they occur;

(e)

sub-regulation (6) thereof shall be amended as

follows

(i) in paragraph (a) thereof, the words "Market

Surveillance Directorate" shall be substituted by the words

"Medicines Authority"; and

(ii) in paragraph (b) thereof, the words "Regulatory

Affairs Directorate" shall be substituted by the words

"Medicines Authority"; and

(f)

sub-regulation (9) thereof shall be amended as

follows

(i) in paragraph (a) thereof, the words "Market

Surveillance Directorate" shall be substituted by the words

"Medicines Authority"; and

(ii) in paragraph (b) thereof, the words "Director of

Market Surveillance" shall be substituted by the words

"Medicines Authority".

In regulation 9 of the principal regulations, the words

"Regulatory Affairs Directorate" shall be substituted by the words

"Medicines Authority" wherever they occur.

In regulation 10 of the principal regulations, the words

"Regulatory Affairs Directorate" shall be substituted by the words

"Medicines Authority".Amends regulation 11 of the principal

regulations.

In regulation 11 of the principal regulations, the words

"Regulatory Affairs Directorate" shall be substituted by the words

"Medicines Authority" wherever they occur.

In regulation 12 of the principal regulations, the words

"Market Surveillance Directorate" shall be substituted by the words

"Medicines Authority".

Regulation 13 of the principal regulations shall be deleted.

11.

In paragraph (4) of Schedule IV to the principal

regulations, the words "Regulatory Affairs Directorate" shall be

substituted by the words "Medicines Authority".

In paragraph (3) of Schedule V to the principal regulations,

the words "Regulatory Affairs Directorate" shall be substituted by the

words "Medicines Authority".

Schedule VI to the principal regulations shall be amended

as follows

(a) the words "Regulatory Affairs Directorate and

Market Surveillance Directorate" shall be substituted by the

words "Medicines Authority".

(b) in paragraph (5) of Schedule VI to the principal

regulations, the words "Regulatory Affairs Directorate" shall be

substituted by the words "Medicines Authority",

In paragraph (2) of Schedule VII to the principal Amends

VII to

regulations, the words "Market Surveillance Directorate, the Schedule

the principal

Regulatory Affairs Directorate" shall be substituted by the words regulations.

"Medicines Authority".

In paragraph (7) of Schedule VIII the words "Regulatory Amends

Affairs Directorate" shall be substituted by the words "Medicines Schedule

VIII to

the principal

Authority" wherever they occur.

regulations.

€0.27