MT · S.L. 427.44
Medical Devices Regulations (S.L. 427.44)
Содержание
- ст. 1 Citation.
- ст. 2009
- ст. 2 Scope and classification.
- ст. 3 Definitions.
- ст. 4 Applicability. 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
- ст. 5 S.L. 427.36
- ст. 6 Conformity assessment procedures.
- ст. 7 Conformity assessment for medical devices manufactured utilising tissues of animal origin.
- ст. 8 Particular procedure for systems and procedure packs and procedure for sterilisation.
- ст. 9 Clinical investigations.
- ст. 10 Withdrawal and prohibition from market.
- ст. 11 Registration of persons responsible for placing devices on the market.
- ст. 12 European databank.
- ст. 13 Notified bodies.
- ст. 14 Confidentiality.
- ст. 15 Penalties. Cap. 427. that, when compromise of users or, be associated the benefits and safety. the ergonomic the device is education and conditions of users). construction the generally solutions, the design and alarms of the manufacturer are suitable for device” in 1, 2 and 3 of the clinical person