S.L. 427.44 Art. 4Applicability. Cap. 458. Cap. 458. Cap. 458. S.L. 427.10 Cap. 458. S.L. 427.58 S.L. 427.38 S.L. 427.35 S.L. 365.15 S.L. 465.01

(1) The provisions of these regulations are applicable to all imported medical devices as well as to those manufactured for the local or Community market.

(2) Where a device is intended to administer a medicinal product within the meaning of article 2 of the Medicines Act, that device shall be governed by these regulations, without prejudice to the provisions of the Medicines Act with regard to the medicinal product:

Provided that:

(a) if such a device is placed on the market in such a way that the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single product shall be governed by the Medicines Act; and

(b) the relevant essential requirements of Schedule I shall apply as far as safety and performance-related device features are concerned.

(3) (a) Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of article 2 of the Medicines Act and which is liable to act upon the body with action ancillary to that of the device, that device shall be assessed and authorised in accordance with these regulations.

(b) Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of article 2 of the Medicines Act and which is liable to act upon the human body with action ancillary to that of the device, hereinafter referred to as a human blood derivative, that device shall be assessed and authorised in accordance with these regulations.

(4) Subject to the definition of a "medical device manufactured utilising tissues of animal origin" in article 3, no person shall place on the Maltese or Community market or put into service a device manufactured utilising either animal tissue which is rendered non-viable or non-viable products derived from animal tissues unless:

(a) there is, in respect of that device, a risk analysis and risk management scheme which is in accordance with the requirements of these regulations, in particular regulations 7(1) to (10) and Schedule XIII; and

(b) the manufacturer of the device has fulfilled his obligations under the procedures within that scheme.

(5) These regulations shall not apply to:

(a) diagnostic devices, as defined in the definition in vitro for "in vitro diagnostic medical device" in article 3;

(b) active implantable devices covered by Directive 90/ 385/EEC, as implemented by the Active Implantable

Medical Devices Regulations;

(c) medicinal products covered by the Medicines Act. In deciding whether a product falls under that Directive or these regulations, particular account shall be taken of the principal mode of action of the product;

(d) cosmetic products covered by the Cosmetic Products

Regulations;

(e) human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells, with the exception of devices referred to in regulation 4(3)(b);

(f) transplants or tissues or cells of human origin nor to product incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in regulation 4(3)(b);

(g) transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.

(6) Where a device is intended by the manufacturer to be used in accordance with both the provisions on personal protective equipment in the Personal Protective Equipment Regulations and these regulations, the relevant basic health and safety requirements of the Personal Protective Equipment Regulations shall also be fulfilled.

(7) These regulations constitute a specific directive within the meaning of regulation 4(5) of the Electromagnetic Compatibility Regulations.

(8) These regulations shall not affect the application of the Nuclear Safety and Radiation Protection Regulations, nor of the

Ionising Radiation Medical Exposure Control Regulations.