Classification of Medical Devices under the EU Directives...
When determining the Classification of Medical Devices the following device / procedure aspects need to be considered:» Duration of contact with the patient – The longer the device is in contact with the patient, the greater the potential for harm. For example a pacemaker inserted for a period of years, offers a greater potential for harm than say a contact lens inserted onto the eye, for a period of hours.
» Degree of invasiveness – Again, considering the pacemaker versus the contact lens. Clearly, the pacemaker is significantly more invasive. While it could be argued that both are inserted into the body, the contact lens, tends to sit on the body versus a surgical intervention.
» Anatomy affected by the use of the device – Where will the medical device operate. Consider a heart pacemaker versus an artificial knee implant. Both are in long term contact with the patient, both are surgically implanted, however, failure or an adverse event in the cardiac region, is clearly of greater potential harm, than in the area around the knee.
» Active or non-active device – Is the device active or passive. The expectation is that active devices offer greater potential risk than passive devices. Examples again would be a heart pacemaker (active) versus knee implant (passive).
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Intended Purpose of the medical device.» The intended purpose of the device determines its classification and not its similarity to other devices.
The intended purpose is critical in considering classification. A device may have a range of applications. A device may even be sold under different brand names to reflect these different purposes. When classifying the device, the intended purpose as stated on the DFU’s (Directions for Use) must be considered. You cannot classify for the lowest risk possible and then apply that classification to all potential device applications, if the alternative application carry a higher potential risk.
When determining the classification of Medical Devices under the EU Directives, it is necessary to clearly understand a range of definitions related to medical devices as defined by the EU under the applicable device directives.
What constitutes a Medical Device.A definition from the EU Medical Directives.
Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
» Diagnosis, prevention, monitoring, treatment or alleviation of disease
» Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
» Investigation, replacement or modification of the anatomy or of a physiological process
» Control of conception
And which does not achieve its principal intended action by pharmacological, chemical, immunological or metabolic means, but which may be assisted in its function by such means.
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Device Classes.Under the EU Directives, the classification of medical device, is based on 4 classes as follows:
» Class I – low risk
» Class IIa – medium risk
» Class IIb – medium risk
» Class III – high risk
Conformity Assessment procedures.The higher the classification of the device the more stringent the conformity assessment is. There are six possible assessment routes, which a manufacturer can follow to obtain approval to market for a medical device, which are:
1. EC declaration of Conformity» Audit of the full quality assurance system by the notified body.
» The device manufacturer must also complete a design dossier.
2. EC Verification
» Notified body examines and tests every individual device or on a statistical basis, the notified body releases individual devices or batches.
3. EC-type examination» Notified body examines and tests a representative sample of device and certifies that the type meets requirements.
4. Production Quality Assurance
» Similar to 1. but excluding product design.
5. Product Quality Assurance
» Performed where product quality can be assessed in final inspection.
6. EC Declaration of Conformity (Type 2)
» Document showing that the products have been designed, manufactured, inspected and labelled properly. Notified body not required for Class I products.
Classification of Medical Devices – Class 1.A Class 1 (lowest risk medical device) does not need a formal or a full quality system. However, such a device does need basic Good Manufacturing Practice (cGMP) requirements as follows:
1) Goods receiving inspection and acceptance.
2) Final inspection and acceptance.
3) Complaint handling.
4) Non-conforming product control.
5) Record keeping.
6) Incident / vigilance reporting.
7) Post market feedback.
8) Advisory notice issue and product recall.
In seeking approval for a quality system, the Notified Body will expect to see compliance with the “Essential Requirements” of the relevant Medical Device Directive. It is up to the manufacturer to decide how to demonstrate compliance. A common approach is the application of relevant European Harmonised Standards. The use of Harmonised Standards (EN ISO) are voluntary but in common use.
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