Clinical Evaluation & PMS for Class IIa/IIb/III Medical Devices

What this is about

The clinical evaluation is the central document with which you demonstrate to your Notified Body that your medical device is safe and fulfils its intended clinical benefit. The MDR sets clear requirements in Article 61 and Annex XIV — and Notified Bodies are reviewing these requirements with increasing rigour.

For manufacturers of Class IIa, IIb and III devices, this means: a clinical evaluation that was sufficient three years ago often no longer meets today’s expectations. Literature searches must be systematic and traceable. Equivalence arguments must be robustly justified. Demonstration of safety and performance must be based on clinically evident data. PMCF can no longer be a placeholder.

I help manufacturers meet exactly these requirements — with documentation that holds up under review.

My services in detail

Clinical Evaluation (CER)

I write complete Clinical Evaluation Reports in accordance with MDR Annex XIV or revise existing evaluations that no longer meet current requirements.

This includes:

• Definition of the clinical evaluation plan
• Identification and appraisal of relevant clinical data
• Systematic literature search following defined protocols
• Appraisal and summary of the clinical evidence
• Conclusions on safety and performance
• Identification of open questions and residual risks

Literature Search

The literature search is the foundation of every clinical evaluation. Notified Bodies pay particular attention to whether the search is systematic, reproducible, and fully documented.

I conduct literature searches that meet these requirements:

• Defined search protocol with databases, search terms, and inclusion/exclusion criteria
• Documented execution and screening results
• Appraisal of identified literature against defined criteria
• Full traceability for the Notified Body

Robustness of Existing Clinical Data

Demonstration of safety and performance relies on clinically evident data.

I provide you with my assessment of:

• Whether the existing clinical data for your medical device can be considered clinically evident and sufficient for certification/re-certification
• How you can close this gap as efficiently as possible in advance

Equivalence Assessment

If you rely on an equivalent device, the justification must meet the strict requirements of the MDR — clinically, technically, and biologically. Under the MDR, without contractual access to the technical documentation of the equivalent device, demonstrating equivalence for Class IIa/IIb/III becomes difficult.

I support you with:

• Assessing whether an equivalence argument is viable
• Systematic comparison of clinical, technical, and biological characteristics
• Documenting equivalence in a form that is traceable for the Notified Body
• An honest assessment of when an equivalence argument is realistic — and when it is not

PMS Plan

The PMS plan describes how you will systematically collect clinical data on your device after market placement. It must be product-specific and cannot consist of generic statements.

I write PMS plans that:

• Define concrete PMS activities including PMCF (not just “literature search will be continued”)
• Address the open questions from the clinical evaluation
• On request, I develop study designs for you
• Specify timelines, responsibilities, and methods
• Meet the requirements of MDCG 2020-7 and MDCG 2020-8

PMS Evaluation Report

The PMS evaluation report (PSUR) documents the results of your PMS activities and their impact on the clinical evaluation. Many manufacturers underestimate this document — yet Notified Bodies are increasingly checking whether PMS has actually been conducted and evaluated.

I write reports that:

• Summarise the activities performed and their results
• Draw conclusions for updating the clinical evaluation
• Clearly state whether the benefit-risk ratio is confirmed
• Provide a traceable justification for the clinical evaluation update cycle

Typical queries I resolve for manufacturers

Notified Bodies repeatedly raise similar questions. If you recognise one or more of these, I can probably help:

“The literature search is not sufficiently systematically documented.”

The search must follow a defined protocol — with documented search strings, databases, time periods, and inclusion/exclusion criteria. I make sure your search meets these requirements.

“The clinical data cited is not sufficient or not acceptable.”

This requires urgent action. Frequently, the scope and/or quality of the collected data is questioned, meaning it cannot be considered “clinically evident”. Often, no further clinical data is collected after initial certification of a device. However, safety and performance must be demonstrated throughout the entire product lifecycle.

“The equivalence argument is not sufficiently justified.”

Often the detailed comparison at clinical, technical, and biological level is missing. Or the argument is inconsistent with the available data. I review your equivalence and revise it where necessary.

“The PMS plan is too generic.”

A PMS plan consisting only of standard phrases will be challenged. I write product-specific plans with concrete activities that address the open questions from your clinical evaluation.

“The clinical evaluation does not reflect the current state of the art.”

The evaluation must show that you know the state of the art and measure your device against it. I update your evaluation with current data and standards.

“The conclusions of the clinical evaluation are not traceable.”

The conclusions must follow logically from the appraised data. If the Notified Body cannot see the thread, there will be queries. I structure your evaluation so that the argument is seamless.

Which devices

I work with manufacturers of Class IIa, IIb and III medical devices. Typical product areas:

• Implantable devices (Class IIb/III)
• Electromedical devices / Active therapeutic devices (Class IIa/IIb/III)
• Software as a Medical Device (SaMD), Class IIa/IIb/III devices

If you’re unsure whether your device falls within my area of focus — let’s clarify that in the initial consultation.