FOI release
FOIA request a temporary restriction on LifeVac
Some or all of the information requested may not have been provided because the request was identical or substantially similar to a previous request from the same requester.
Case reference FOI2025/00327
Received 31 March 2025
Published 30 May 2025
Request
This is a request for information filed under the FOI Act. Please confirm receipt. 1) According to: https://imedconsultancy.com/lifevac-europe-ltd/ In 2017, the MHRA imposed a temporary restriction on LifeVac, limiting its sales to the care sector, which required LifeVac Europe to meet stringent regulatory demands and reporting requirements for an innovative device intended for an unmet medical need. During this period, Matthew Burton worked tirelessly to help LifeVac Europe meet rigorous regulatory demands, including the preparation of detailed Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) reports on a quarterly basis until significant sufficient data was generated to allow the restrictions to be lifted in June 2023. After this point the device could now be used as intended. Please provide me with copies of all quarterly Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) reports submitted by or on behalf of LifeVac Europe Ltd from August 2017 through June 2023 including all related correspondence. Please redact any confidential and/or proprietary company information, and identify the appropriate statutes justifying each redaction. 2) From https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/667136/Item_07__2017-OB-14__CEOs_Report_Nov_17.pdf LifeVac - We took a number of enquiries about MHRA's regulation of LifeVac, an antichoking device. After liaising with colleagues in Devices, we sent a statement to Huffington Post, Daily Mail, Cambrian News and Sunday Times Ireland. Re: all of the above inquiries (Huffington Post, Daily Mail, Cambrian News and Sunday Times Ireland), please provide me with copies of all related correspondence. Please provide the records in digital format via e-mail if possible. I'm requesting these records for an article I'm reporting on my blog and I have no financial interest in the requested information, therefore this is to request that any fees be waived. If the fee for completing my request exceeds 5 pounds, please obtain my written approval prior to completing this request. Please send the requested records as ready rather than accumulated in a single response. Finally, please include instructions on how I may appeal your response. Thank you for your attention and I look forward to your confirmation of receipt and to receiving the requested records.
Response
see attached
Documents
- 327-Buzfeed 2.png (87.2 KB)
- 327-Buzzfeed.png (97.2 KB)
- 327-Cambrian.png (131.4 KB)
- 327-Daily Mail.png (232.9 KB)
- 327-Huff post 1.png (125.3 KB)
- 327-Huff post 2.png (173.4 KB)
- 327-Huff post 3.png (134.4 KB)
- 327-Irish Mail.png (208.5 KB)
- 327-Sunday Times Irealand .png (173.0 KB)
- FOI2025_00327 redacted for publication.pdf (106.9 KB)
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