Your Definitive Guide to CE Marking
It continues to ail with Philips Respironics’ devices. After yesterday’s publication on the recall of the V60 family of ventilators, we now continue with the problems surrounding Philips Respironics’ sleep apnea and respiratory devices.
The EU MDR (Medical Device Regulation) tends to follow the approach of the US FDA (Food and Drug Administration). In the current situation, it tightens the existing regulatory framework for medical devices in Europe in a way that is unacceptable to many market participants.
According to a poll from Boston Consulting Group, the United States has surpassed the European Union as the most important market for medical device makers, with 89 percent of MedTechs planning to prioritize the US Food and Drug Administration (FDA) approval in the future.
In November 2021 we published the article: Philips is liable for health problems’ say users of apnea devices. Four Dutch users of a Philips device used to treat sleep apnea, the Dreamstation 1, are holding the manufacturer liable for health problems. Their lawyer Mr. Mark de Hek has announced this in a letter to the company. The users say they suffer from headaches or breathing problems or have cancer.