The European Union (EU) issued new medical device regulations (MDR) in May 2017 to ensure high standards of safety and quality for all CE-marked medical devices and accessories sold into Europe and countries that accept or request CE-marked products. It does not apply to consumables or components. The EU MDR replaces the Medical Devices Directive [93/42/EEC] and Active Implantable Medical Device Directive [90/385/EEC].
Our products are marked with our authorized representative address, our legal entity designated by the European Union to represent us in the EU and to ensure our compliance with the European Directives.
As part of Regulatory requirements under EU MDR, all of our medical device and accessory products display the manufacturer address.
Each one of our products is labeled with a CE marking (CE or CE0123), a certification mark or “stamp of approval” that indicates we comply with all applicable health, safety, and environmental protection standards for products sold within the European Economic Area (EEA).
Potential risks associated with each product are detailed in each product’s user manual/instructions for use (IFU).
Product(s) or Product Type | Warning |
AutoSV | For Consumers: Your physician should assess the use of this device if you have chronic, symptomatic heart failure with an LVEF < 45% and moderate to severe predominant central sleep apnea. For Businesses: A physician should assess the use of this device if a patient has chronic, symptomatic heart failure with an LVEF < 45% and moderate to severe predominant central sleep apnea. |
Invasive Ventilation (e.g. Trilogy Evo) | Qualified personnel should monitor ventilator-dependent patients. Personnel should be prepared to provide alternate therapy in the event of ventilator failure, alarms, or inoperative equipment. |
SE Full, Total and Leak 1 Masks (e.g. FitLife Total Face Mask, Amara Silicone Full face SE and Amara Gel Full face SE) | A separate exhalation device must be used with this mask. Do not use this mask unless the therapy device is turned on and is operating properly. |
OSA Pediatric Masks | Use in presence of adult caregiver. |
Oxygen concentrators - Portable and stationary (e.g. EverFlo, Millennium, SimplyGo, SimplyGo Mini) | Oxygen should not be used while smoking or in the presence of an open flame. |
Data Management Software (e.g. Encore Anywhere, DirectView, Care Orchestrator, Care Orchestrator Essence) | Data from these products are only one of several elements to consider when evaluating therapy effectiveness and are not a substitute for diagnostic data or patient monitoring. |
Masks that use Magnetic Clips (e.g. Wisp, DreamWisp, AmaraView, DreamWear Full face) | Some medical devices may be affected by magnetic fields. The magnetic clips in this mask should be kept at least 2 in. (50 mm) away from any active medical device with special attention to implanted devices such as pacemakers, defibrillators and cochlear implants. Do not use in or near magnetic resonance imaging (MRI) equipment. |