The CE mark for implantable medical devices.
A vital aspect of device and implant regulation is continual surveillance of performance after approval. Most permanent implants seldom reveal their strengths and weaknesses until they have been in clinical use for a number of years. It is vital that clinicians report problems to the manufacturers and regulatory authorities to enable emerging hazards to be promptly identified.
Randall
H
H
Medical Devices Agency, London SE1 6TQ.
Croft
R J
RJ
D004869:Equipment Safety / Q000592:standards; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D019736:Prostheses and Implants / Q000592:standards*; D011786:Quality Control