Edmund Proffitt, BDTA policy and public affairs director, commented, “The industry can breathe a sigh of relief as MEP’s have seen sense and agreed to key amendments in the new Medical Devices Regulations. As it now stands, dentists should be able carry on using a vast range of products that will not be needlessly upclassified or adversely affected by the new legislation”.
Prior to the recent important vote in the European Parliament the BDTA took the opportunity to lobby all the UK MEPs sitting on the influential ENVI Committee, which played an important role in influencing the recent Parliamentary vote.
MEPs were urged to support important amendments to the directive relating to nanomaterials and implant cards which would provide a sensible solution to an area of the regulation which, if left unchanged, could have caused significant and unnecessary problems for a whole range of common medical and dental products.
Without amendment the proposals on nanomaterials would have adversely affected a significant range of materials and products, including simple items such as surgical gloves and many commonly used dental products, such as composite filling materials, impression materials, adhesives, prostheses and artificial teeth. Similarly the proposals on implantable devices could have unnecessarily subjected dental fillings to the requirements for “implant cards” as required for implantable medical devices.
The BDTA continues to work with other organisations on a range of issues throughout the process of the review including the re-use and upclassification of instruments, pre-authorisation and the responsibilities of economic operators.