FOI release

Class I medical device submission- reference 2025042201417535

Some or all of the information requested was not provided because we determined that the cost to do so would exceed the appropriate limit.

Case reference FOI2025/00395

Received 23 April 2025

Published 23 July 2025

Request

Please provide enough of the iatroX registration file (MHRA reference 2025042201417535) (https://www.iatrox.com/) to show the type and level of evidence the manufacturer relied upon to demonstrate the device’s safety and performance at the time of self-declaration. To protect any genuinely confidential material, I am asking only for summary-level information or suitably redacted extracts, namely — Clinical evaluation / performance evidence A synopsis (or redacted copy) of the Clinical Evaluation Report (CER) or Performance Evaluation Report that identifies: the kinds of data reviewed (e.g. published literature, bench testing, post-market data, clinical studies) and their relative weighting; any pivotal clinical investigations, including study design and subject numbers (titles and protocols may be redacted if necessary); the manufacturer’s overall conclusion on clinical safety and performance and any residual risks accepted. Essential safety and performance requirements evidence map The table or matrix that links each essential requirement of the UK MDR 2002 to the evidence cited (test reports, standards, literature, etc.). A redacted version showing document titles and evidence types, with confidential details removed, would be sufficient. Post-market surveillance (PMS) approach A brief description or summary table of the PMS activities the manufacturer committed to (e.g. complaints trend analysis, periodic safety update reports, user surveys). Applied standards and intended purpose The list of harmonised or designated standards applied; the intended purpose statement and rule(s) used to justify Class I classification. Registrant details Name and address of the legal manufacturer and UK Responsible Person (if different).

Response

see attached

Documents

• FOI2025_00395 redacted for publication.pdf (175.2 KB)

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