Re: How a fake hip showed up failings in European device regulation
Congratulations on your excellent investigative journalism on faulty medical devices.
I would like to suggest that you extend the scope of your investigation to IVDs (in vitro diagnostic medical devices).
The European regulatory process for IVDs is even more lax than that for devices. For example, for some types of IVD, a CE mark can be obtained by simply by self certification.
Unfortunately for the patients who are misagnosed, faulty diagnostic test devices are (I would guess) unlikely to create the scandal that faulty treatment devices have.
So, now would be the best time possible to put pressure on the authorities to improve the systems for ensuring the safety of medical treatment devices and diagnostic test devices.
Here's a challenge for you: get a CE mark for an IVD that reads the tea leaves in the bottom of a cup.
Rapid Response:
Re: How a fake hip showed up failings in European device regulation
Congratulations on your excellent investigative journalism on faulty medical devices.
I would like to suggest that you extend the scope of your investigation to IVDs (in vitro diagnostic medical devices).
The European regulatory process for IVDs is even more lax than that for devices. For example, for some types of IVD, a CE mark can be obtained by simply by self certification.
Unfortunately for the patients who are misagnosed, faulty diagnostic test devices are (I would guess) unlikely to create the scandal that faulty treatment devices have.
So, now would be the best time possible to put pressure on the authorities to improve the systems for ensuring the safety of medical treatment devices and diagnostic test devices.
Here's a challenge for you: get a CE mark for an IVD that reads the tea leaves in the bottom of a cup.
Competing interests: No competing interests