Medical Device Regulation
The European medical devices industry is regulated via three
Directives:
Active Implantable Medical Devices Directive
(89/385/EEC)
Medical Devices Directive (93/42/EEC)
In Vitro Diagnostics Medical Devices Directive
(98/79/EC)
Guidance on the Medical Devices Directives
can be found on the Commission website.
Various Notified Bodies are responsible for carrying out
regulatory inspections of medical device manufacturers and their
products under each of the three directives.
More information about these organisations is available on the
Commission website:
The UK Regulator, the Medicines & Healthcare products Regulatory
Agency also offers a great deal of helpful guidance on its
site and it is recommended reading.
ABHI holds regular meetings with the MHRA and UK Notified Bodies
in the Tripartite Meeting; however, this group has a restricted
membership. The purpose of these meetings is to discuss the
UK input to the EU Notified Bodies Operations Group.
Details of the current situation on Medical Device Regulation is
available to members via the ABHI electronic newsletter
Technical Update.