WHO has issued a global model regulatory norms for medical devices including IVDS. The industry is expected to comment on new regulations and submit the same before end of September 2016.
The model norms intend to bring in effective and efficient regulatory framework. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and the International Medical Device Regulators Forum (IMDRF).
The norms are particularly relevant for WHO member states with no or limited regulation for medical devices in place.
The classification rules for non-IVD medical devices depend on the features of the device, like for instance whether it is life supporting, invasive, incorporates medicinal products, human or animal tissues or cells. The device should also be specified if an active medical device delivers medicinal products, energy or radiation, could modify blood or other body fluids.
For IVDs, the risk classification depends both on the risk for the individual and for public health. The importance of the information to the diagnosis, screening, monitoring or staging of disease and the impact of the test result to the individual and/or to public health, need to be specified.
The GHTF has published documents on the classification of medical devices and IVDs. These rules have been widely accepted. Additionally, the regulatory authority may develop explanatory guidance to help a manufacturer apply the rules. While the manufacturer has the primary obligation to classify its medical device, its decision may be challenged by the regulatory authority, said WHO.
The general essential principles of safety and performance for medical devices include the processes for the design and production. The manufacturers and developers should ensure that a medical device when used according to the intended purpose does not compromise the clinical condition of the patient or the health of the user. Further, the manufacturer should perform a risk assessment to identify known and foreseeable risks and to mitigate these risks in the design, production and use of the medical device. The manufactures also ensure that the device should not be damaged during transport or packaging and storage.
Therefore, ensuring that a medical device consistently conforms to the essential principles is primarily the responsibility of the manufacturer. The documented evidence of conformity is subject to review by the regulatory authority before or after market introduction, said WHO.
The degree of involvement of the regulatory authority in the assessment of a medical device is dependent on the risk class. For instance higher the risk class, the greater is the involvement of the regulatory authority. Clinical evidence, assessing conformity to the Essential Principles for regulation of IVDs must comply with regulatory requirements similar to those for other medical devices, said WHO.