answer text |
<p>No estimate has been made. The Medicines and Healthcare products Regulatory Agency
(MHRA) has not received any reports to indicate that Second Sight have withdrawn or
failed to provide product support to existing patients. Additionally, NHS England
does not routinely commission products supplied by Second Sight.</p><p>No assessment
of the risk of medical device companies collapsing had been made. While there is an
obligation on manufacturers to confirm the safety and performance of the devices throughout
their lifetime, if a company is sold, the liability for these post-market requirements
is usually a matter for the contract between parties. The MHRA is considering how
post-market obligations on manufacturers can be strengthened in the forthcoming amendments
to the Medical Devices Regulations 2002.</p><p>When contracting for the supply of
medical devices, due diligence is undertaken on the financial standing of a supplier
by procurement teams to gain assurance of the supplier’s ability to maintain supply
in line with contractual and regulatory obligations. Patients remain in the care of
prescribing clinicians who will make decisions on treatment and care in the event
that supply of a product or service is disrupted. The Department monitors supply threats
through engagement with suppliers and trade associations and uses intelligence to
identify potential disruptions.</p>
|
|