Rules for Classification
1(c) A non-invasive device to be used for wounds that have breached the dermis and where the wounds can only heal by secondary intent—Class C.
2(d) A non-invasive device to store blood – i.e. blood bags -Class C.
Note: if the blood bags have a function greater than storing purposes and include systems for preservation other than anti-coagulants then other rules may apply.
3(a) A non-invasive device to modify the biological or chemical composition of blood, other body liquids, or other liquids to be infused in the patient—Class C.
6(c) A surgically invasive device for transient use to supply energy in form of ionising radiation—Class C.
6(d) A surgically invasive device for transient use to have a biological effect or be wholly or mainly absorbed—Class C.
6(e) A surgically invasive device for transient use to administer medicine via a delivery system, and where the administration is potentially hazardous to the patient—Class C.
7(b) A surgically invasive device for short-term use to administer medicine—Class C.
7(c) A surgically invasive device for short-term use to undergo a chemical change in a patient’s body(except a device intended to be placed in the teeth)—Class C.
7(d) A surgically invasive device for short-term use to supply energy in the form of ionising radiation - Class C.
8(o) Implantable maxillo-facial implants and devices such as nails, plates and screws for small joints and long term orthopaedic use– Class C
9 (i)(b) An active device to administer or exchange energy in a potentially hazardous way, having regard to the nature, density and site of application of the energy—Class C.
(The term “potentially hazardous” refers to the type of technology involved and the intended application)
9(ii) An active device to control or monitor, or directly influence the performance of an active medical device for therapy of the kind in the previous entry—Class C.
10(i)(d) A device to diagnose and or monitor vital physiological parameters of a patient, and the nature of variations monitored could result in immediate danger to the patient—Class C.
Note: For this clause ‘variations monitored’, is taken to mean that the result of monitoring could lead to immediate danger to the patient. This is typically, but not always, accompanied by an alarm.
10(ii)(a) A device to emit ionising radiation and to be used for diagnostic or therapeutic interventional radiology—Class C.
10(ii)(b) A device to control, monitor or directly influence the performance of a device in the previous entry—Class C.
11(b) An active device to administer or remove medicine, body liquids or other substances in a way that is potentially hazardous to the patient, having regard to the substances, the part of the body concerned, and the characteristics of the device—Class C.
15(a) A device specifically for sterilising medical devices, or disinfecting as the end point of processing - Class C.
15(c) A device specifically for disinfecting, cleaning, rinsing or, when appropriate, hydrating contact lenses - Class C.
Note: this clause does not apply to a medical device that is intended only to clean another medical device (other than contact lenses) by means of physical action—these devices are Class A.
16 (a) A device for contraception or the prevention of sexually transmitted diseases—Class C.
|blood bags (including those containing or coated with an anticoagulant)|
|catheters containing or incorporating radioactive isotopes where the isotope is not intended to be released into the body|
|personal insulin injectors|
|surgical / tissue adhesives|
|bone plates (orthopedic use)|
|bone screws (orthopedic use)|
|high-frequency electrosurgical generators|
|radioactive sources for after- loading therapy|
|external feedback systems for active therapeutic devices|
|intensive care monitoring systems|
|diagnostic x-ray sources|
|auto exposure control systems|
|hard contact lens solutions|
|Denture disinfecting products|
|Washers-disinfectors for endoscopes|
|Disinfectants for the fluid pathways of haemodialysis equipment|
|Disinfectants for ocular prosthesis|
|intraosseous transcutaneous amputation prosthesis|
|surgical equipment and invasive dental equipment|
|after-loading control devices|
|physiotherapy ultrasound devices|
|radiotherapy afterloading controls systems|
|warming blankets for unconscious patients|
|blood gas analysers used in open- heart surgery|
|electroconvulsive therapy equipment|
|heat exchangers used in intensive care|
|therapeutic X-ray sources|
|blood pumps for heart-lung machines|
|pressure regulators for medical gases|
|medical gas mixers|
|moisture exchangers in breathing circuits|
|nebulisers where the failure to deliver the appropriate dosage form could be hazardous|