The Central Drugs Standard Control Organization on 7th July 2022, has published a Draft Guidance document on Overview on Performance Evaluation / External Evaluation of In-vitro Diagnostic Medical Device (IVDMD). This guidance document is applicable to manufacturers/ importers / Testing laboratories of In-vitro diagnostics (IVD) in India.
IVDs are fundamentally different from other medical devices because they perform their function outside of the body on specimens taken from the human body. The specimens are obtained via normal body functions (e.g. urine) or through the use of invasive medical devices to allow for the specimen to be obtained (e.g. biopsy). A significant percentage of all healthcare decisions rely on information provided by clinical laboratory tests and these decisions can profoundly influence diagnosis and management of the patient and will be influenced by the risk to the patient of an incorrect result from the IVDs.
Performance evaluation at Independent / External laboratory of in vitro diagnostics (IVDs) are required, to verify certain performance claims that are considered essential by which data are assessed and analyzed to demonstrate the performance of IVDs for the intended use as stated by the manufacturer.
Therefore, as per the draft guidance, the laboratory premises shall be air conditioned so as to maintain the accuracy and functioning of laboratory instruments or to enable the performance of special tests such as, microbiological tests, etc. The testing and evaluation of IVDs shall be under active direction of a person whose qualification and experience is considered adequate and who shall be held responsible for reports of test or evaluation issued.
The laboratory should maintain records of tests for evaluation and performance carried out on all samples of medical devices and the results thereof together with protocols of tests and the reports showing readings and calculations and such records shall be retained, in case of substances for which an expiry date is assigned, for a period of two years beyond the expiry date, and in the case of other substances, for a period of six years.
HIV, hepatitis B and hepatitis C and other viruses are transmissible by blood and body fluids. Therefore, all types of specimens must be handled as potentially infectious. Appropriate precautions to minimize infectious hazards must be taken at all stages from the collection of specimens to the disposal of used materials from the laboratory.
The sample of IVDs shall be sent by registered post or by courier or by hand in a sealed packet, enclosed with a covering letter along with necessary documents in an outer cover addressed to the HOD, of the testing laboratory. A copy of covering letter may be endorsed or acknowledged.
