Medical Devices (Amendment) Regulations, 2020

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

L.N. 320 of 2020

MEDICINES ACT

(CAP. 458)

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 Medical Devices Citation.

(Amendment) Regulations, 2020 and these regulations shall be read

and construed as one with the Medical Devices Regulations hereinafter S.L. 427.44.

referred to as "the Regulations"..

In regulation 2 of the principal regulations, the words Amends

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

the principal

"Medicines Authority" wherever they occur.

regulations.

(1) Regulation 3 of the principal regulations shall be Amends

regulation 3of

amended as follows

the principal

regulations.

(a) the definitions "hip, knee and shoulder replacement",

"Market Surveillance Directorate" and "Regulatory Affairs

Directorate" shall be deleted; and

(b) immediately after the definition "medical device

manufactured utilising tissues of animal origin" 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 (5) thereof, the words "Regulatory

Affairs Directorate" shall be substituted by the words "Medicines

Authority"; and

(b) in sub-regulation (12) thereof, the words "Head of the

Regulatory Affairs Directorate" shall be substituted by the words

"Medicines Authority".

In regulation 7 of the principal regulations, the words

"Regulatory Affairs Directorate" shall be substituted by the words

"Medicines Authority" wherever they occur.

In sub-regulation (5) of regulation 8 of the principal

regulations, the words "Regulatory Affairs Directorate" 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.

Regulation 10 of the principal regulations shall be amended

as follows

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

Market Surveillance" shall be substituted by the words

"Medicines Authority";

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

Surveillance Directorate and the Regulatory Affairs Directorate"

shall be substituted by the words "Medicines Authority";

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

Affairs Directorate" shall be substituted by the words "Medicines

Authority";

(d) in paragraph (b) of sub-regulation (5) thereof, the

words "Regulatory Affairs Directorate" shall be substituted by

the words "Medicines Authority";

(e)

sub-regulation (8) thereof shall be substituted by the

following new sub-regulation

"(8) Where the Medicines Authority considers, in

relation to a given product or group of products, that, in

order to ensure the protection of health and safety and, or to

ensure that public health requirements are observed, such

products should be withdrawn from the market, or their

placing on the market and putting into service should be

prohibited, restricted or subjected to particular

requirements, any necessary and justified transitional

measures may be taken.

The Medicines Authority shall immediately inform

the Commission and all other Member States of any

measures taken in pursuance of sub-regulations (1) to (10),

giving the reasons for such decisions."; and

(f)

sub-regulation (9) of the principal regulations shall

be amended as follows

(i) in paragraph (a) thereof, the words "Director of

Market Surveillance" 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 11 of the principal regulations, the words Amends

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

the principal

"Medicines Authority".

regulations.

In sub-regulation (2) of regulation 12 of the principal Amends

regulations, the words "Regulatory Affairs Directorate" shall be regulation

the principal

substituted by the words "Medicines Authority".

regulations.

In regulation 13 of the principal regulations, the words Amends

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

the principal

"Medicines Authority".

regulations.

Sub-regulation (1) of regulation 14 of the principal Amends

regulations shall be substituted by the following new sub-regulation: regulation

the principal

regulations.

"(1) Without prejudice to the existing national provisions

and practices on medical secrets, the Medicines Authority shall

ensure that all the parties involved in the application of these

regulations are bound to observe confidentiality with regard to

all information obtained in carrying out their tasks. This does not

affect the obligation of the Medicines Authority with regard to

mutual information and the dissemination of warnings, nor the

obligation of the persons concerned to provide information under

criminal law.".

Regulation 15 of the principal regulations shall be deleted.

Deletes

regulation 15 of

the principal

regulations.

€0.18