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Clinical Evaluation

SFDA requirement​

The SFDA requires manufacturers to provide a Clinical Evaluation Report (CER) as part of the MDMA technical file for most device classes. The depth and extent of clinical evidence required scales with device risk class.

What clinical data is required by class?​

ClassClinical evidence expectation
Class A (non-As/Am/Ar)Abbreviated; may rely on equivalence, literature review, and general safety data
Class A (As, Am, Ar)More detailed; specific performance data required
Class BCER required; equivalence to predicate acceptable with evidence; literature and/or PMS data
Class CCER required; clinical data specific to device type preferred; equivalence requires strong justification
Class DComprehensive CER required; clinical investigation data preferred or strong equivalence demonstration

Clinical Evaluation Report (CER)​

The CER must follow a structured approach:

  1. Scope of clinical evaluation — intended purpose, claims, populations
  2. Literature review — systematic search of published evidence for this device type
  3. Equivalence — demonstration that equivalent devices share same intended use, technical and biological characteristics (with documented evidence)
  4. Clinical investigation data — where available or required
  5. Post-market clinical data — PMCF and PMS data for marketed devices
  6. Overall conclusion — whether clinical evidence supports the intended purpose and that the benefit-risk profile is acceptable

Using foreign clinical data​

The SFDA accepts clinical data generated in other countries provided it is relevant to the Saudi patient population and intended use. Data from GHTF member country trials (EU, US, Canada, Japan, Australia) is generally acceptable.

Clinical investigations in Saudi Arabia​

Where new clinical data must be generated in-country, manufacturers must obtain SFDA approval for clinical investigations conducted in Saudi Arabia. This involves:

  • Submission of a clinical investigation plan
  • Ethics committee approval
  • SFDA authorisation before investigation commencement

PMCF as pre-market input​

For higher-risk devices, the SFDA expects a PMCF plan to be in place from the time of initial MDMA. PMCF data collected post-market feeds back into the CER at renewal.

Further reading​