May 9, 2018
The new medical device rule “MDR 2017, India” has come into effect from January 2018. In line with that, the CDSCO (Central Drug Standard Control Organization) has recently been releasing guidance documents, guideline articles and various other important updates to provide binding guidance for use in the manufacturing and registration of medical devices which are intended to be sold in India. Just like that, CDSCO has released a new draft guidance document, which briefly highlights the essential principles for safety and performance of various medical devices (MDs) based on rule 6 of MDR 2017.
In general, there are 3 levels of standard used to meet the medical devices’ essential principles for safety and performance. These need to be considered as a whole i.e. basic standard, group standard and product standard. Basic standards cover standards indicating fundamental concepts, principles, with regard to general safety which are applicable to wide range of products, whereas group standards cover aspects applicable to families of similar products making reference as far as possible to basic standards. Finally, product standards indicate necessary safety and performance of specific products making reference as far as possible, to basic standards and group standards.
It is important to mention that IVD medical devices have been separated from medical devices in the new rule although the classification for each type follows class A, class B, class C and class D categories. There are some essential principles stated for all MDs including IVDs and some essential principles for MDs except IVDs whereas some are specifically made for IVDs.
Essential principles for all classes of MDs mostly emphasize on the fact that it should be designed and manufactured in such a way that they will perform as intended by the user without compromising the clinical conditions and safety of patients. Every medical device requires clinical evidence, appropriate for its intended use and classification of the medical device, demonstrating that the device complies with the applicable provisions of the essential principles.
Coming to the product standards of MDs; care should be taken during manufacturing keeping following aspects in mind i.e. (1) Chemical, physical and biological properties (2). Infection and microbial contamination (3) MDs incorporating materials of biological origin (4). Environmental properties (5) Performance evaluation (6) Protection against radiation (7) MDs that incorporate software and standalone medical device software (8) active devices (9) protection against mechanical and thermal risks (10) performance evaluation including analytical performance and, where appropriate, clinical performance. For IVD medical devices above points still hold along with some additions related to use of reagents or biomolecules. For new IVDs, clinical evaluation studies using specimens from human subjects should be carried out.