US Food and Drug Administration (FDA)
The US FDA conducts regular inspections of Arjo’s production units to ensure regulatory compliance. The FDA requires that Arjo complies with the quality system regulation for medical devices in the US. Arjo’s MDSAP certification confirms that these requirements have been met.
Health Canada Medical Device Regulation
Health Canada regulates products in accordance with the Canadian food and drugs legislation, which also covers medical devices. This is achieved by evaluating medical devices to assess their safety, effectiveness and quality before being approved for sale in Canada. Health Canada requires that Arjo is MDSAP-certified to be able to sell medical devices on the Canadian market.
EU Medical Device Regulation (MDR)
Affecting everyone that conducts business within the medical device industry in the EU, the new MDR regulation comes into effect May 2021, with a grace period until the expiry of current CE certificates. As early as 2017, Arjo has mobilised a cross-functional task force and worked closely with our notified bodies to ensure we meet the requirements of the new EU-MDR. As of January 2021 our Class Im devices and Class II intermittent compression pumps have been MDR certified, and in May 2021 our class I devices are fully MDR compliant. For our remaining Class II and III devices, the existing CE-mark is valid until June 2023 and we are on track to achieving MDR certification well ahead of this deadline.