Clinical Evaluation & PMCF
Medical device and IVD manufacturers are under increasing pressure to demonstrate and maintain clinical evidence under EU MDR, EU IVDR, UK, and other regulatory frameworks. Clinical evaluation is no longer a one-time activity. It is an ongoing requirement tied directly to market access, post-market surveillance, and continued compliance.
AJW Technology Consultants, Inc. prepares clinical evaluation documentation and defines clinical strategies used directly in regulatory submissions and ongoing updates. The work is centered on Clinical Evaluation Reports (CER) and the PMCF activities that maintain them.
Where Clinical Activities Occur
Clinical evidence is developed and maintained across the product lifecycle. Early-stage work defines what evidence is required. Market access depends on a complete and defensible clinical evaluation. Once the device is on the market, that evaluation must be maintained through PMCF
and ongoing updates.
The clinical evaluation is the central document throughout this lifecycle. PMCF activities exist to generate the data required to keep it current.
Early Stage — Defining Clinical Approach
Clinical work begins with determining what evidence is required for the device, its intended use,and its claims.
This includes defining how safety and performance will be demonstrated, whether existing literature is sufficient, and where additional data may be required. The output is a clear clinical approach that can be used to build the Clinical Evaluation Plan and avoid rework later in the process.
Market Access — Clinical Evaluation (CEP & CER)
The Clinical Evaluation Report is the primary document used to demonstrate safety and performance for regulatory review. Its quality directly affects market access and review outcomes.
AJW Tech prepares:
- Clinical Evaluation Plans (CEP) tied to device claims, intended use, and risk profile
- Systematic literature reviews with defined search, screening, and selection methodology
- Appraisal of clinical data, including relevance, quality, and weight of evidence
- Demonstration of conformity with applicable safety and performance requirements
- Identification, justification, and documentation of residual clinical gaps
- Clinical Evaluation Reports (CER) prepared for submission and notified body review
Post-Market — Maintaining Clinical Evidence (PMCF)
Clinical evaluation does not end at market access. The CER must be maintained as new data becomes available and as part of ongoing compliance expectations.
PMCF activities generate the data required to support that process.
AJW Tech prepares:
- PMCF Plans based on identified clinical gaps and CER conclusions
- Selection of PMCF methods appropriate to the device, risk, and available data
- PMCF Evaluation Reports documenting results and conclusions
- Updates to the CER incorporating PMCF data and post-market information
PMCF activities are part of broader post-market surveillance requirements.
Additional detail on post-market surveillance and PMCF activities is available here →
When Manufacturers Engage AJW Tech
Manufacturers typically engage AJW Tech when clinical documentation does not meet current expectations or requires update.
This includes situations such as:
- Clinical Evaluation Reports developed under MDD that require update for MDR or IVDR
- Notified body feedback identifying deficiencies in clinical evaluation or PMCF
- Clinical evidence that does not adequately support device claims or intended use
- PMCF activities that are undefined or not clearly connected to the clinical evaluation
How the Work Is Performed
Clinical documentation is prepared for direct use in submissions, technical documentation, and audit review. The work is connected to risk management, post-market activities, and regulatory strategy so that the outputs remain consistent across the system.
AJW Tech can work independently or alongside your internal team and existing partners.
Contact AJW Tech About Clinical Services
If you are preparing for regulatory submission, updating a Clinical Evaluation Report, or addressing PMCF requirements, AJW Tech prepares the clinical documentation required for regulatory use.