S.L. 427.44 Art. 9Clinical investigations.

(1) In the case of devices intended for clinical investigations to be conducted in Malta, the manufacturer or the authorised representative shall follow the procedure referred to in

Schedule VIII and notify the Medicines Authority by means of the statement mentioned in section 2(b) of Schedule VIII.

(2) (a) In the case of devices falling within Class III and implantable and long-term invasive devices falling within Class IIa or IIb, the manufacturer may commence the relevant clinical investigation at the end of a period of sixty days after notification, unless the Medicines Authority have notified him within that period of a decision to the contrary based on considerations of public health or public policy.

(b) However, manufacturers may be authorised by the Medicines Authority to commence the relevant clinical investigations before the expiry of the period of sixty days, in so far as the Ethics Committee, established by the Clinical Trials Regulations, has issued a favourable opinion on the programme of investigation in question, including its review of the clinical investigation plan.

(3) In the case of devices other than those referred to in sub-regulation (2), manufacturers may be authorised by the Medicines Authority to commence clinical investigations immediately after the date of notification, provided that the Ethics Committee mentioned above has issued a favourable opinion on the programme of investigation in question including its review of the clinical investigation plan.

(4) The clinical investigations must be conducted in accordance with the provision of Schedule X.

(5) (a) If necessary, any appropriate steps to ensure public health and public policy shall be taken according to the Public Health Act.

(b) Where a clinical investigation is refused or halted, the Medicines Authority shall communicate such decision and the grounds thereof to all Member States and the Commission. Where a significant modification or temporary interruption of a clinical investigation has been called, the Medicines Authority shall inform the Member States concerned about such actions and the grounds for the actions taken.

(6) (a) The manufacturer or his authorised representative shall notify the Medicines Authority and the competent authorities of the other Member States concerned of the end of the clinical investigation, with a justification in case of early termination.

(b) In the case of early termination of the clinical investigation on safety grounds, the notification referred to in paragraph (a) shall be communicated by the Regulatory Affairs Directorate to all Member States and the Commission.

(c) The manufacturer or his authorised representative shall keep the report referred to in section 2(c)(vii) of Schedule X at the disposal of the Medicines Authority and the competent authorities of the other Member States concerned.

(7) The provisions of sub-regulations (1) and (2) do not apply where the clinical investigations are conducted using devices which are authorised in accordance with regulation 6(1) to (12) to bear the CE marking unless the aim of these investigations is to use the devices for a purpose other than that referred to in the relevant conformity assessment procedure. The relevant provisions of Schedule X remain applicable.