The medical technology industry has answered the call by the government around the world to help fight the pandemic. This means a marked increase in the production of machines and other medical equipment.
How has this emergency situation affected the regulations that govern the industry?
Since the speed of production is the main priority as the infection numbers continue to climb, this has actually led to a relaxing of some regulations in countries around the world. The EU, for example, was due to fully implement its Medical Device Regulation by this month (it has slowly been rolling out since 2017) but the industry has asked the European Parliament and Council to delay implementation by a year, as manufacturers rush to produce the equipment that is so heavily in demand in the midst of the crisis. They are doing so as they also struggle to manage the effects of the outbreak within their organisations, which has disrupted their efforts to implement the stipulations of the MDR within the deadline set in place three years ago.
The situation is much the same elsewhere. Medical equipment manufacturers are working overtime to keep hospitals and other facilities supplied with the instruments they need. They are essentially in emergency mode, which has meant that legislative guidelines and watchdog stipulations are taking a backseat.
This is not to say that existing regulations will be put on hold, however. Standards and norms will still be followed as closely as possible. Manufacturers have acknowledged that such items as ventilators and PPE must be prioritised at the current time, in line with the needs of healthcare facilities. Both the private and public healthcare sectors are experiencing increased demand for this equipment. This may lead to either de facto or de jure emergency regulations by governments to ensure that medical technology manufacturers only produce the items that are needed specifically to fight COVID-19, in much the same way that other industries are either shut down or limited to producing essential goods.
It is uncertain when such emergency measures will be lifted – it all depends on how we do in flattening the curve of infection over the course of the coming few months.