How can your SaMD pass the clinical evaluation phase in the EU?

Before we dive into clinical evaluation, what is SaMD (Software as a Medical Device) exactly?

A SaMD refers to software intended for medical purposes without being part of a physical medical device. Examples include applications for computers, mobile phones, or tablets designed to treat, diagnose, relieve, monitor, or cure medical conditions. FibriCheck—a certified smartphone app detecting cardiac irregularities—exemplifies pure SaMD, installed directly on users’ smartphones rather than embedded in physical hardware.

SaMD offers substantial benefits including rapid data collection and analysis, quicker efficiency than clinician-conducted monitoring, and early detection of patient condition changes. This enables preventative care and reduces risks of serious illness progression.

Clinical evaluation for SaMD in EU markets

Clinical evaluation ensures SaMD conforms to regulatory requirements. The process analyzes clinical data to verify safety and clinical usefulness while identifying previously undetected risks.

Why do you need to perform clinical evaluation for SaMD?

In the EU, clinical evaluation follows five stages: planning, identification of relevant data, appraisal, potential new data generation through clinical investigation, and reporting.

What is the MDR and the IVDR, and why do they matter when building SaMD?

The MDR (Medical Device Regulation) governs medical device manufacture and distribution in the EU, effective May 26, 2021, ensuring high quality and safety standards. The IVDR (In Vitro Medical Device Regulation) regulates in-vitro medical devices, entered into force May 26, 2017, with full application by May 26, 2022. Both frameworks establish essential requirements for SaMD development and compliance.

The three main components in the EU clinical evaluation stage

1. Valid Clinical Association of the SaMD

Developers must prove valid association between SaMD output (measurements, conclusions) and targeted clinical conditions using clinical research findings, trials, or secondary data analysis.

2. Analytical / Technical Validation of the SaMD

Manufacturers must demonstrate that SaMD correctly processes input data to produce accurate, reliable output while proving proper software construction according to regulatory requirements.

3. Clinical Validation of the SaMD

Developers must establish that SaMD-produced data is clinically meaningful and beneficial. Clinical data collection methods include: published clinical experience data, clinical investigations, clinical investigations with equivalent devices, or combinations thereof.

How to improve the likelihood of passing the clinical evaluation phase for a SaMD

How is the clinical evaluation phase regulated?

Clinical evaluation is regulated under MDR Article 61, paragraph 3, with additional requirements in Annex XIV. The Annex XIV process requires following a Clinical Evaluation Plan with these stages:

1. A planning stage
2. An identification stage of relevant clinical data
3. An appraising stage for data
4. Potential new data generation through clinical investigation (if necessary)
5. A reporting stage

Three MDR points exceed MEDDEV requirements:

1. Clinical Evaluation Plan establishment must include:

   • Identification of safety and performance requirements requiring clinical data support
   • Specification of intended device purpose
   • Specification of intended target groups
   • Description of intended clinical benefits
   • Specification of methods examining clinical safety qualitative and quantitative aspects
   • Parameters listing for benefit-risk ratio determination
   • Clinical development plan showing progression from exploratory to confirmatory investigations
   • Resulting Clinical Evaluation report

2. PMCF (Post-Market Clinical Follow-up Studies) Plan outlining post-market SaMD follow-up methods.

3. PMCF Evaluation Report requirement during post-market phase.

Ensure that your SaMD processes data in a compliant, secure way

SaMD with connectivity components must prove data integrity—demonstrating accuracy, consistency, completeness, and secure processing compliant with GDPR requirements. Utilizing medical Backend-as-a-Service platforms like Extra Horizon implements data protection standards from inception, simplifying GDPR-compliant SaMD development.

Make sure you build a strong QMS from day one

Effective Quality Management Systems from development onset prove invaluable for clinical evaluation. QMS documentation ensures proper procedure and process recording while promoting continuous improvement. During analytical and technical evaluation phases, QMS generates evidence of proper input data processing and regulatory-compliant software construction.

Quality management for SaMD primarily involves ISO 13485:2016 standard compliance—an international requirement for EU sales. CE Mark acquisition requires MDR compliance, which mandates ISO 13485:2016 certification.

How Extra Horizon can help carry the burden of passing the Clinical Evaluation phase

Saving precious time and money

Extra Horizon’s medical Backend-as-a-Service enables configuration rather than in-house construction, conserving time and resources for focusing on clinical evaluation phases.

Regulatory certifications

Extra Horizon holds multiple certifications:

• ISO 13485:2016 — Quality Management System standard for medical devices and CE-approval prerequisite.
• ISO 27001:2017 — Information and data security standard demonstrating internationally acknowledged best practices.
• ISO 27701:2019 — Specifications for Privacy Information Management Systems.
• IEC 62304:2015 — Safe design and maintenance specifications for software.
• EU Cloud CoC (Code of Conduct) — Demonstrating commitment to safe, compliant cloud backend environments and GDPR requirement compliance.

To conclude

Clinical evaluation presents substantial challenges, but regulatory attention and robust QMS development ensure successful navigation. Extra Horizon’s pre-compliant, ready-made medical BaaS further alleviates clinical evaluation pressures.