Section 53. IVD Classification Rules Background 53.1. The classification rules under the UK medical devices regulations enable a high proportion of IVDs (~80%) to be placed onto the market on the basis of self-declaration. Self-declaration is a process whereby a manufacturer can self-declare compliance to the relevant regulatory requirements without undergoing a third-party conformity assessment. 53.2. The UK medical devices regulations provide for four categories of IVDs, in order of increasing perceived risk to patient safety:General IVDs, i.e. all IVDs other than those covered below IVDs for self-testing (a medical device intended by the manufacturer to be able to be used by lay persons in a home environment) - excluding self-test medical devices covered below IVDs in the classifications stated in Part IV of the UK medical devices regulations, Annex II List B [^1]: which, amongst others, includes reagents products for rubella, toxoplasmosis and phenylketonuria as well as medical devices for self-testing for blood sugar. 更多資訊 Section 54. Genetic Testing Background 54.1. Genetic tests can be used to provide information and data on a person's predisposition to developing a medical condition or disease. They can be used in healthcare under supervision of a medical professional or they can be purchased directly by individual members of the public who can perform the test at home and send their sample to a lab to obtain their results. Possible Changes and Questions 54.2. The UK medical devices regulations do not currently include specific requirements relating to genetic testing. Under the current regulations it is possible for a genetic test to receive a CE or UKCA marking on the basis of an analytical study which demonstrates the medical device's performance. This is due to these devices being classified as low-risk devices under the current UK medical device regulations. There has been a long-standing concern amongst stakeholders that the current regulatory requirements are not sufficiently robust within this area. This includes requiremen... 更多資訊
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