diff --git a/NAMESPACE b/NAMESPACE
index 0afd85824e..f7cd7b31b5 100644
--- a/NAMESPACE
+++ b/NAMESPACE
@@ -248,6 +248,7 @@ export(labels_use_control)
 export(level_order)
 export(logistic_regression_cols)
 export(logistic_summary_by_flag)
+export(mantel_fleiss_crit)
 export(month2day)
 export(or_clogit)
 export(or_glm)
diff --git a/NEWS.md b/NEWS.md
index e78982c4da..c22b73c0f7 100644
--- a/NEWS.md
+++ b/NEWS.md
@@ -1,6 +1,8 @@
 # tern 0.9.11.9000
 
 ### Enhancements
+* Added `mantel_fleiss_crit()` to check the Mantel-Fleiss criterion
+  for stratified 2 x 2 contingency tables.(#1512)
 * Updated `g_forest()` to support point estimates and confidence intervals
   stored in a single column. (#1499)
 * Added the `exclude_rows` argument to `g_forest()` to allow excluding selected
diff --git a/R/prop_diff_test.R b/R/prop_diff_test.R
index f36647379d..1c680fd576 100644
--- a/R/prop_diff_test.R
+++ b/R/prop_diff_test.R
@@ -481,3 +481,137 @@ prop_fisher <- function(tbl, alternative = c("two.sided", "less", "greater")) {
   tbl <- tbl[, c("TRUE", "FALSE")]
   stats::fisher.test(tbl, alternative = alternative)$p.value
 }
+
+#' @title Check the Mantel-Fleiss Criterion
+#'
+#' @description `r lifecycle::badge("stable")`
+#'
+#' Checks the Mantel-Fleiss criterion for stratified 2 x 2 contingency tables.
+#'
+#' @details
+#' The Mantel-Fleiss statistic is calculated as
+#'
+#' \deqn{
+#' MF = \min\left(
+#' [\sum_h m_{11h} - \sum_h {(n_{11h})}_L],\
+#' [\sum_h {(n_{11h})}_U - \sum_h m_{11h}]
+#' \right),
+#' }
+#'
+#' where \eqn{h} indexes the non-empty strata. For each stratum \eqn{h}, the
+#' expected frequency of cell \eqn{(1, 1)} in table \eqn{h}, under the
+#' hypothesis of no association between group and response, is
+#'
+#' \deqn{
+#' m_{11h} = \frac{n_{1.h} n_{.1h}}{n_h}.
+#' }
+#'
+#' The lower and upper bounds for \eqn{n_{11h}}, given the marginal totals,
+#' are:
+#'
+#' \deqn{
+#' {(n_{11h})}_L = \max(0, n_{1.h} - n_{.2h}),
+#' }
+#' \deqn{
+#' {(n_{11h})}_U = \min(n_{.1h}, n_{1.h}).
+#' }
+#'
+#' The Mantel-Fleiss criterion is satisfied when \eqn{MF \ge 5}.
+#'
+#' Strata with all cell counts equal to zero are excluded from the
+#' calculation. If all strata contain zero observations, there are no
+#' non-empty strata over which to calculate the Mantel-Fleiss statistic, and
+#' the statistic is therefore undefined. In this case, the function returns
+#' `NA`.
+#'
+#' @param tbl (`array`)\cr
+#'   A three-dimensional contingency table containing the counts for each
+#'   combination of group, response, and stratum. The first two dimensions
+#'   must correspond to the two variables defining the 2 x 2 contingency
+#'   table (group and response), in either order. The third dimension must
+#'   correspond to the strata. The first two dimensions must each have exactly
+#'   two levels. All cell values must be finite, non-missing integer counts.
+#' @param include_value (`logical(1)`)\cr
+#'   Whether to include the calculated Mantel-Fleiss statistic as an attribute
+#'   of the result.
+#'
+#' @return A logical value indicating whether the Mantel-Fleiss criterion
+#' is satisfied. If `include_value = TRUE`, the result also contains a
+#' value attribute with the calculated Mantel-Fleiss statistic. If there
+#' are no non-empty strata, the result is `NA` and the value attribute is
+#' `NA_real_`.
+#'
+#' @author WW
+#'
+#' @examples
+#' set.seed(123)
+#' n <- 40
+#'
+#' grp <- factor(sample(c("Active", "Control"), n, replace = TRUE))
+#' rsp <- sample(c(TRUE, FALSE), n, replace = TRUE)
+#' strata1 <- factor(sample(c("A", "B"), n, replace = TRUE))
+#' strata2 <- factor(sample(c("x", "y"), n, replace = TRUE))
+#' strata <- interaction(strata1, strata2)
+#'
+#' tbl <- table(grp, rsp, strata)
+#' tbl
+#'
+#' mantel_fleiss_crit(tbl)
+#' mantel_fleiss_crit(tbl, include_value = TRUE)
+#'
+#' @references
+#' Mantel, N., and Fleiss, J. L. (1980).
+#' Minimum Expected Cell Size Requirements for the Mantel-Haenszel
+#' One-Degree-of-Freedom Chi-Square Test and a Related Rapid Procedure.
+#' \emph{American Journal of Epidemiology}, 112(1), 129--134.
+#'
+#' @export
+mantel_fleiss_crit <- function(tbl, include_value = FALSE) {
+  checkmate::assert_array(tbl, mode = "integerish", any.missing = FALSE, d = 3L)
+  checkmate::assert_true(all(tbl >= 0L))
+  checkmate::assert_true(all(is.finite(tbl)))
+  checkmate::assert_true(nrow(tbl) == 2L)
+  checkmate::assert_true(ncol(tbl) == 2L)
+  checkmate::assert_flag(include_value)
+
+  # Drop strata with no observations.
+  tbl <- tbl[, , apply(tbl, 3L, sum) > 0, drop = FALSE]
+
+  # Add marginal totals over the group and response dimensions,
+  # retaining the stratum dimension.
+  tbl_mrgn <- stats::addmargins(tbl, margin = 1:2)
+
+  # If there are no non-empty strata, the Mantel-Fleiss criterion is undefined
+  # because there are no strata over which to calculate it.
+  if (dim(tbl)[3L] == 0L) {
+    is_satisfied <- NA
+    if (include_value) {
+      attr(is_satisfied, "value") <- NA_real_
+    }
+    return(is_satisfied)
+  }
+
+  n_1dot <- tbl_mrgn[1L, "Sum", ]
+  n_dot1 <- tbl_mrgn["Sum", 1L, ]
+  n_dot2 <- tbl_mrgn["Sum", 2L, ]
+  n <- tbl_mrgn["Sum", "Sum", ]
+
+  # Expected value of n_11 under the hypothesis of no association
+  # between group and response (within a given stratum).
+  m_11 <- (n_1dot * n_dot1) / n
+  # Lower and upper bounds for n_11 given the marginal totals (within a given stratum).
+  n_11_lwr <- pmax(0L, n_1dot - n_dot2)
+  n_11_upr <- pmin(n_dot1, n_1dot)
+
+  mf_value <- min(
+    sum(m_11) - sum(n_11_lwr),
+    sum(n_11_upr) - sum(m_11)
+  )
+
+  is_satisfied <- mf_value >= 5
+  if (include_value) {
+    attr(is_satisfied, "value") <- mf_value
+  }
+
+  is_satisfied
+}
diff --git a/_pkgdown.yml b/_pkgdown.yml
index d6e0e13c6f..06ce089982 100644
--- a/_pkgdown.yml
+++ b/_pkgdown.yml
@@ -113,6 +113,7 @@ reference:
       - -h_xticks
       - -prop_diff
       - check_diff_prop_ci
+      - mantel_fleiss_crit
 
   - title: rtables Helper Functions
     desc: These functions help to work with the `rtables` package and may be
diff --git a/inst/WORDLIST b/inst/WORDLIST
index fd4ab057f3..0c77c4e15a 100644
--- a/inst/WORDLIST
+++ b/inst/WORDLIST
@@ -15,6 +15,7 @@ CMH
 CQ
 Clopper
 Coull
+Fleiss
 Haenszel
 Hauck
 Hilferty
diff --git a/man/mantel_fleiss_crit.Rd b/man/mantel_fleiss_crit.Rd
new file mode 100644
index 0000000000..819035cb0b
--- /dev/null
+++ b/man/mantel_fleiss_crit.Rd
@@ -0,0 +1,95 @@
+% Generated by roxygen2: do not edit by hand
+% Please edit documentation in R/prop_diff_test.R
+\name{mantel_fleiss_crit}
+\alias{mantel_fleiss_crit}
+\title{Check the Mantel-Fleiss Criterion}
+\usage{
+mantel_fleiss_crit(tbl, include_value = FALSE)
+}
+\arguments{
+\item{tbl}{(\code{array})\cr
+A three-dimensional contingency table containing the counts for each
+combination of group, response, and stratum. The first two dimensions
+must correspond to the two variables defining the 2 x 2 contingency
+table (group and response), in either order. The third dimension must
+correspond to the strata. The first two dimensions must each have exactly
+two levels. All cell values must be finite, non-missing integer counts.}
+
+\item{include_value}{(\code{logical(1)})\cr
+Whether to include the calculated Mantel-Fleiss statistic as an attribute
+of the result.}
+}
+\value{
+A logical value indicating whether the Mantel-Fleiss criterion
+is satisfied. If \code{include_value = TRUE}, the result also contains a
+value attribute with the calculated Mantel-Fleiss statistic. If there
+are no non-empty strata, the result is \code{NA} and the value attribute is
+\code{NA_real_}.
+}
+\description{
+\ifelse{html}{\href{https://lifecycle.r-lib.org/articles/stages.html#stable}{\figure{lifecycle-stable.svg}{options: alt='[Stable]'}}}{\strong{[Stable]}}
+
+Checks the Mantel-Fleiss criterion for stratified 2 x 2 contingency tables.
+}
+\details{
+The Mantel-Fleiss statistic is calculated as
+
+\deqn{
+MF = \min\left(
+[\sum_h m_{11h} - \sum_h {(n_{11h})}_L],\
+[\sum_h {(n_{11h})}_U - \sum_h m_{11h}]
+\right),
+}
+
+where \eqn{h} indexes the non-empty strata. For each stratum \eqn{h}, the
+expected frequency of cell \eqn{(1, 1)} in table \eqn{h}, under the
+hypothesis of no association between group and response, is
+
+\deqn{
+m_{11h} = \frac{n_{1.h} n_{.1h}}{n_h}.
+}
+
+The lower and upper bounds for \eqn{n_{11h}}, given the marginal totals,
+are:
+
+\deqn{
+{(n_{11h})}_L = \max(0, n_{1.h} - n_{.2h}),
+}
+\deqn{
+{(n_{11h})}_U = \min(n_{.1h}, n_{1.h}).
+}
+
+The Mantel-Fleiss criterion is satisfied when \eqn{MF \ge 5}.
+
+Strata with all cell counts equal to zero are excluded from the
+calculation. If all strata contain zero observations, there are no
+non-empty strata over which to calculate the Mantel-Fleiss statistic, and
+the statistic is therefore undefined. In this case, the function returns
+\code{NA}.
+}
+\examples{
+set.seed(123)
+n <- 40
+
+grp <- factor(sample(c("Active", "Control"), n, replace = TRUE))
+rsp <- sample(c(TRUE, FALSE), n, replace = TRUE)
+strata1 <- factor(sample(c("A", "B"), n, replace = TRUE))
+strata2 <- factor(sample(c("x", "y"), n, replace = TRUE))
+strata <- interaction(strata1, strata2)
+
+tbl <- table(grp, rsp, strata)
+tbl
+
+mantel_fleiss_crit(tbl)
+mantel_fleiss_crit(tbl, include_value = TRUE)
+
+}
+\references{
+Mantel, N., and Fleiss, J. L. (1980).
+Minimum Expected Cell Size Requirements for the Mantel-Haenszel
+One-Degree-of-Freedom Chi-Square Test and a Related Rapid Procedure.
+\emph{American Journal of Epidemiology}, 112(1), 129--134.
+}
+\author{
+WW
+}
diff --git a/tests/testthat/test-mantel_fleiss_crit.R b/tests/testthat/test-mantel_fleiss_crit.R
new file mode 100644
index 0000000000..60b1e0fa87
--- /dev/null
+++ b/tests/testthat/test-mantel_fleiss_crit.R
@@ -0,0 +1,172 @@
+test_that("mantel_fleiss_crit() works with multiple observations and strata", {
+  tbl <- array(
+    c(9L, 8L, 6L, 9L, 6L, 5L, 8L, 5L, 5L, 5L, 5L, 4L, 11L, 5L, 7L, 2L),
+    dim = c(2L, 2L, 4L)
+  )
+
+  expect_silent(
+    result <- mantel_fleiss_crit(tbl)
+  )
+  expect_silent(
+    result_val <- mantel_fleiss_crit(tbl, TRUE)
+  )
+
+  expect_identical(result, TRUE)
+  expect_identical(result_val, result, ignore_attr = TRUE)
+  expect_equal(attributes(result_val), list(value = 20.16857), tolerance = 1e-6)
+})
+
+test_that("mantel_fleiss_crit() works with small stratified data and dimnames", {
+  tbl <- array(
+    c(2L, 2L, 1L, 2L, 0L, 1L, 2L, 1L, 1L, 1L, 3L, 1L, 1L, 0L, 1L, 1L),
+    dim = c(2L, 2L, 4L),
+    dimnames = list(grp = c("Gr1", "Gr2"), rsp = c("T", "F"), strata = LETTERS[1:4])
+  )
+
+  expect_silent(
+    result <- mantel_fleiss_crit(tbl)
+  )
+  expect_silent(
+    result_val <- mantel_fleiss_crit(tbl, TRUE)
+  )
+
+  expect_identical(result, FALSE)
+  expect_identical(result_val, result, ignore_attr = TRUE)
+  expect_equal(attributes(result_val), list(value = 2.785714), tolerance = 1e-6)
+})
+
+test_that("mantel_fleiss_crit() works with 1 stratum", {
+  tbl <- array(c(4L, 4L, 7L, 5L), dim = c(2L, 2L, 1L))
+
+  expect_silent(
+    result <- mantel_fleiss_crit(tbl)
+  )
+  expect_silent(
+    result_val <- mantel_fleiss_crit(tbl, TRUE)
+  )
+
+  expect_identical(result, FALSE)
+  expect_identical(result_val, result, ignore_attr = TRUE)
+  expect_equal(attributes(result_val), list(value = 3.6), tolerance = 1e-6)
+})
+
+test_that("mantel_fleiss_crit() ignores unobserved strata levels", {
+  tbl <- array(
+    c(1L, 4L, 3L, 3L, 5L, 0L, 7L, 4L, 0L, 0L, 0L, 0L, 3L, 1L, 0L, 6L),
+    dim = c(2L, 2L, 4L)
+  )
+
+  expect_silent(
+    result <- mantel_fleiss_crit(tbl)
+  )
+  expect_silent(
+    result_val <- mantel_fleiss_crit(tbl, TRUE)
+  )
+
+  expect_identical(result, TRUE)
+  expect_identical(result_val, result, ignore_attr = TRUE)
+  expect_equal(attributes(result_val), list(value = 5.231818), tolerance = 1e-6)
+})
+
+test_that("mantel_fleiss_crit() returns NA when all cell counts equal zero", {
+  tbl <- array(rep(0L, 16L), dim = c(2L, 2L, 4L))
+
+  expect_silent(
+    result <- mantel_fleiss_crit(tbl)
+  )
+  expect_silent(
+    result_val <- mantel_fleiss_crit(tbl, TRUE)
+  )
+
+  expect_identical(result, NA)
+  expect_identical(result_val, result, ignore_attr = TRUE)
+  expect_identical(attributes(result_val), list(value = NA_real_))
+})
+
+test_that("mantel_fleiss_crit() handles a stratum with observations in one cell only", {
+  tbl <- array(c(1L, 1L, 1L, 1L, 0L, 4L, 0L, 0L), dim = c(2L, 2L, 2L))
+
+  result <- mantel_fleiss_crit(tbl)
+  result_val <- mantel_fleiss_crit(tbl, TRUE)
+
+  expect_identical(result, FALSE)
+  expect_identical(result_val, result, ignore_attr = TRUE)
+  expect_equal(attributes(result_val), list(value = 1), tolerance = 1e-6)
+})
+
+test_that("mantel_fleiss_crit() includes the MF = 5 boundary", {
+  tbl <- array(c(5L, 5L, 10L, 10L), dim = c(2L, 2L, 1L))
+
+  result <- mantel_fleiss_crit(tbl, include_value = TRUE)
+
+  expect_identical(result, TRUE, ignore_attr = TRUE)
+  expect_identical(attributes(result), list(value = 5))
+})
+
+test_that("mantel_fleiss_crit() handles data with no non-responses", {
+  tbl <- array(c(2L, 4L, 0L, 0L), dim = c(2L, 2L, 2L))
+
+  result <- mantel_fleiss_crit(tbl)
+  result_val <- mantel_fleiss_crit(tbl, TRUE)
+
+  expect_identical(result, FALSE)
+  expect_identical(result_val, result, ignore_attr = TRUE)
+  expect_identical(attributes(result_val), list(value = 0))
+})
+
+test_that("mantel_fleiss_crit() handles data with no responses", {
+  tbl <- array(c(0L, 0L, 4L, 0L), dim = c(2L, 2L, 2L))
+
+  result <- mantel_fleiss_crit(tbl)
+  result_val <- mantel_fleiss_crit(tbl, TRUE)
+
+  expect_identical(result, FALSE)
+  expect_identical(result_val, result, ignore_attr = TRUE)
+  expect_identical(attributes(result_val), list(value = 0))
+})
+
+test_that("mantel_fleiss_crit() works with observations from one group only (Gr1)", {
+  tbl <- array(c(46L, 0L, 4L, 0L), dim = c(2L, 2L, 2L))
+
+  result <- mantel_fleiss_crit(tbl)
+  result_val <- mantel_fleiss_crit(tbl, TRUE)
+
+  expect_identical(result, FALSE)
+  expect_identical(result_val, result, ignore_attr = TRUE)
+  expect_identical(attributes(result_val), list(value = 0))
+})
+
+test_that("mantel_fleiss_crit() works with observations from one group only (Gr2)", {
+  tbl <- array(c(0L, 30L, 0L, 3L), dim = c(2L, 2L, 2L))
+
+  result <- mantel_fleiss_crit(tbl)
+  result_val <- mantel_fleiss_crit(tbl, TRUE)
+
+  expect_identical(result, FALSE)
+  expect_identical(result_val, result, ignore_attr = TRUE)
+  expect_identical(attributes(result_val), list(value = 0))
+})
+
+test_that("mantel_fleiss_crit() validates inputs", {
+  # tbl
+  expect_error(mantel_fleiss_crit(matrix(1L, nrow = 2, ncol = 2)))
+  expect_error(mantel_fleiss_crit(array(1L, dim = c(2L, 2L, 2L, 1L))))
+  expect_error(mantel_fleiss_crit(array(1L, dim = c(3L, 2L, 2L))))
+  expect_error(mantel_fleiss_crit(array(1L, dim = c(2L, 3L, 2L))))
+
+  # Missing / invalid values.
+  dim3d <- c(2L, 2L, 2L)
+  expect_error(mantel_fleiss_crit(array(NA_integer_, dim = dim3d)))
+  expect_error(mantel_fleiss_crit(array("1", dim = dim3d)))
+  expect_error(mantel_fleiss_crit(array(NA_real_, dim = dim3d)))
+  expect_error(mantel_fleiss_crit(array(NaN, dim = dim3d)))
+  expect_error(mantel_fleiss_crit(array(-1, dim = dim3d)))
+  expect_error(mantel_fleiss_crit(array(-1L, dim = dim3d)))
+  expect_error(mantel_fleiss_crit(array(Inf, dim = dim3d)))
+
+  # include_value
+  tbl <- array(1L, dim = c(2L, 2L, 3L))
+  expect_error(mantel_fleiss_crit(tbl, include_value = c(TRUE, FALSE)))
+  expect_error(mantel_fleiss_crit(tbl, include_value = 1L))
+  expect_error(mantel_fleiss_crit(tbl, include_value = 1))
+})