Device Regulators, MHRA, Publish Draft for Comment on Vigilance Systems for CE-Marked Medical Devices – Cardiac Ablation Catheters.
Full Text Here
This guidance document gives advice to manufacturers on the notification of adverse incidents involving cardiac ablation catheters (CACs) under the Medical Devices
Vigilance System. It is intended to facilitate the uniform application and implementation of Medical Devices Directive 93/42/EEC and amended by 2007/47/EC. It is
supplementary to, and should be read in conjunction with, the European Commission Guidelines on a Medical Devices Vigilance System, and MHRA Directives Bulletin 3
- Guidance on the operation of the EU vigilance system in the UK . This guidance sets out the Medicines and Healthcare products Regulatory Agency’s
(MHRA) 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.
Development Consultancy
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
