Authorisation medical device

The previous chapter outlined how device classification and the use of standards provide the basis for effective regulation of medical devices, with particular focus on the application of design control standards to the development of devices. In this chapter we look at the process for evaluation and authorisation of devices, and see how the regulatory requirements vary depending on the perceived risk of the device as indicated by its classification. It will be noted that there is considerable variation between the approaches adopted in Europe and the US and that, compared to dmgs, practical harmonisation of requirements still remains to be adopted. 

One court has interpreted the FD C Act as not authorising FDA to require restitution by a manufacturer to purchasers of a product that has been found to violate the FD C Act, but a more recent court decision has upheld restitution. The Medical Device Amendments of 1976 explicitly provide such authority for medical devices. ... 

The priority review is applicable for orphan drugs, orphan medical devices and innovative drugs or medical devices that have been authorised to be highly necessary from a medical standpoint. The standards to define orphan drugs are the following (1) patient number of disease indicated for the drug concerned is less than 50 000 (2) excellent usefulness of the drug from the medical standpoint and (3) the development... 

Adverse drug reaction (ADR) is defined in the law. The person authorised for the drug prescription, wholesale, dispensation and manufacture is obliged to report an ADR to the SIDC. The SIDC has the right to postpone or withdraw the medicinal products or medical device from the market. 

As stated in 23 Obligations of the McU keting Authorisation Holder of the new Law No. 140/1998 on medical products and medical devices, the MA holder is obliged to ensure that the properties of the medicinal products registered are in accordance with the documentation submitted with the application for registration. Therefore, the MA holder heis to apply for any intended variation concerning the registered product and its documentation, cis is customary in the EU. There are no differences between type I and 11 variations. 

The amount of detail for approval of the device increases from Class I to Class III. In the UK submission of data and subsequent approval is through the Medical Device Agency (MDA). Devices have to be independently assessed by MDA Notified Bodies, which on approval can issue the authorised CE mark this allows unrestrained distribution across Europe. 

Validation requires specialised knowledge and calibrated expensive equipment and is, therefore, often outsourced to a certified third party. Based on the validation reports, the responsible person (pharmacist, sterile medical devices expert) can judge whether each steriliser functions well and authorises the final validation report. 

A new device that is specifically made in accordance with a duly qualified medical practitioner s written prescription and which gives, under the practitioner s responsibility, specific design characteristics, and is intended for the sole use of a particular patient is permitted to be marketed without CE marking imder provisions referring to custom-made devices. The prescription may be made by any person authorised by virtue of their professional qualifications to do so. Mass produced devices that need to be adapted to meet the specific requirements of the medical practitioner or any other professional user are not considered to be custom-made devices. 

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