MT · S.L. 427.10
Active Implantable Medical Devices (S.L. 427.10)
Inhoud
- Art. 1 Citation.
- Art. 2 Scope.
- Art. 3 Definitions.
- Art. 4 Applicability. Cap. 458. Cap. 458. Cap. 458. S.L. 427.35 Cap. 458.
- Art. 5 CE marking and conformity. S.L. 427.36
- Art. 6 Conformity assessment procedures.
- Art. 7 Clinical investigations.
- Art. 8 Withdrawal and prohibition from market.
- Art. 9 Registration of persons responsible for placing devices on the market.
- Art. 10 European databank.
- Art. 11 Notified bodies.
- Art. 12 Confidentiality.
- Art. 13 Penalties. Cap. 427. I (1) The used under compromise any risk to the (2) The namely that for one or specified by (3) The not be the patients or, of the device stresses which (4) The their transport (5) Any when weighed (6) clinical II (7) The of the devices acknowledged (8) reusable pack placed on t