Company: INGN
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0000950170-25-029993
Chunk: 22

Company: Inogen Inc
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1
Chunk 22
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 third-party assessment may consist of an audit of the manufacturer’s quality system by reference to ISO 13485, review of technical documentation, and specific testing of the manufacturer’s device. Such an assessment may be required in order for a manufacturer to commercially distribute the product throughout the EEA. We have completed the necessary conformity assessment procedure required to allow us to affix the CE Mark to our oxygen therapy products and to commercialize our devices in the EEA, through the EU MDD and MDR processes. Our ISO 13485 certification was first issued on April 21, 2005, and our EC-Certificate was first issued on March 16, 2007. We received the CE Mark for our oxygen therapy products under the MDR on December 12, 2022.

Following the United Kingdom’s exit from the European Union, known as “Brexit”, the MDR does not apply in the United Kingdom (except for Northern Ireland, which under the Northern Ireland Protocol is bound by certain EU laws). The medical device legislative framework in the United Kingdom is set out in the Medical Devices Regulations 2002, as amended. These Regulations are based on the previous medical device directives of the EU (including the MDD) but have been amended so that they function properly now the United Kingdom is no longer part of the European Union. The Medical Devices Regulations 2002 have introduced several changes including (but not limited to) replacing the CE mark with a UK Conformity Assessed, or UKCA, marking (although CE marks will be recognized potentially up until June 2030), requiring manufacturers outside of the United Kingdom to appoint a “UK Responsible Person” if they place devices on the Great Britain market and more wide-ranging UK device registration requirements.

Inogen has sold products in Canada since 2006 when we obtained our Medical Device License after obtaining appropriate licensure, accreditation, and meeting ISO Standard 13485. As of January 1, 2019, Health Canada implemented the Medical Device Single Audit Program as the sole mechanism for manufacturers to demonstrate compliance with the quality management system requirements of the Medical Device Regulations, replacing the Canadian Medical Devices Conformity Assessment System program. 

In Australia, we must appoint an agent sponsor who will interact on our behalf with the Therapeutics Goods Administration, or TGA. We must also prepare a technical file and declaration of conformity to essential requirements under Australian law, provide evidence of CE Marking of the device and submit this information via our agent sponsor to the TGA in a Medical Device Application.