Manufacturers must notify the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) of any serious adverse events related to the deterioration or malfunction of a CE-Marked coronary stent or inadequate instructions for its use, according to a new guidance. The guidance is intended to bring the UK’s vigilance system in line with the Medical Devices Directive 93/42/EEC and European Commission guidelines.
This guidance sets out the MHRA’s views on the interpretation of the medical devices regulations. It should not be considered to be an authoritative statement of the law in any particular case as it is intended as guidance only. Manufacturers and others should consult the legislation referred to, making their own decisions on matters affecting them in conjunction with their lawyers and other professional advisers. The MHRA does not accept liability for any errors, omissions, misleading or other statements in the guidance whether negligent or otherwise. An authoritative statement could be given only by the courts.