Medical Devices Regulations

1 Heart valve

2 Annuloplasty ring

3 Active implantable device systems

• (a) all models of implantable pacemakers and leads;

• (b) all models of implantable defibrillators and leads;

• (c) artificial heart;

• (d) implantable ventricular support system; and

• (e) implantable drug infusion system

4 Devices of human origin

• (a) human dura mater; and

• (b) wound covering containing human cells