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Clinical evaluation — overview

Regulatory basis

MDR Art. 61 and Annex XIV. Clinical evaluation is mandatory for all MDR devices regardless of class. It is a continuous, lifecycle process — not a one-time pre-market exercise.

Disclaimer

This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.

What is clinical evaluation?​

A clinical evaluation is a systematic and planned process to continuously generate, collect, analyse, and assess clinical data pertaining to a device — in order to verify its safety and performance, including clinical benefits, when used as intended.

It is not simply a literature review. It is a structured scientific methodology that results in a Clinical Evaluation Report (CER) and feeds into the risk management file, technical documentation, and post-market activities.

Clinical evaluation is mandatory for all classes​

MDR Art. 61(1) is unambiguous: clinical evaluation is required for all devices, irrespective of class. There is no "de minimis" exemption for simple Class I devices.

However, the depth and nature of the clinical evaluation scales with device risk:

ClassTypical clinical evaluation approach
Class ILiterature-based; often brief; clinical investigation rarely needed
Class IIaLiterature + equivalence (where applicable) + some clinical data from PMS
Class IIbLiterature + substantial clinical data; equivalence heavily scrutinised
Class IIIFull clinical evidence; equivalence increasingly difficult to establish; clinical investigation often required

The clinical evaluation process — Annex XIV Part A​

Annex XIV Part A defines the required stages:

Stage 1 — Identify applicable GSPR requiring clinical evidence​

Review the GSPR and identify which require clinical data for their demonstration. For most devices, this includes at minimum:

  • GSPR §1 (fundamental safety and performance — clinical benefit vs. risk)
  • GSPR §3 (performance as claimed under conditions of use)
  • GSPR §6 (biological safety, where clinical performance data informs biocompatibility)

Stage 2 — Identify available clinical data​

Sources of clinical data include:

  • Clinical investigations of the device itself (pre- or post-market)
  • Clinical investigations of an equivalent device
  • Published peer-reviewed literature on the device or equivalent device
  • Post-market clinical follow-up (PMCF) data
  • Post-market surveillance data (complaints, vigilance, registry data)

Stage 3 — Appraise the clinical data​

Each data source is critically appraised for:

  • Relevance to the device under evaluation
  • Scientific validity (study design, methodology, bias risks)
  • Clinical weight (how much confidence the data supports)

A literature search protocol (with documented search strategy, databases, inclusion/exclusion criteria) is required.

Stage 4 — Generate new clinical data if necessary​

If existing data is insufficient to demonstrate safety and performance, new clinical data must be generated — through a clinical investigation (pre-market) or PMCF (post-market).

Stage 5 — Analyse the clinical data​

Synthesise all appraised data to reach conclusions on:

  • Whether the device achieves its claimed performance
  • Whether the benefit-risk is positive and acceptable
  • Whether GSPR requiring clinical evidence are met
  • Whether residual uncertainties exist and how they will be addressed through PMCF

Stage 6 — Write the Clinical Evaluation Report​

Document all of the above in a structured CER. See Clinical Evaluation Report (CER).

The equivalence pathway​

If the manufacturer does not have sufficient clinical data from their own device, they may use clinical data from an equivalent device. Equivalence under MDR is strictly defined — all three criteria must be met:

CriterionWhat is required
ClinicalSame intended use, same medical indication, same user population, same part of the body
TechnicalSame design, same materials in contact with the body, same deployment method, similar specifications
BiologicalSame materials, same duration of contact, same absorption characteristics

Access to equivalence data: MDR Art. 61(5) requires the manufacturer to have sufficient access to the technical documentation of the equivalent device. For a device from a different manufacturer, this requires a contractual arrangement granting access. This is a significant change from MDD practice, where publicly available literature was often deemed sufficient.

For Class III and implantable Class IIb devices: equivalence to a device from a different manufacturer is only permitted in exceptional, justified circumstances. The expectation is that Class III devices will have their own clinical investigations.

When clinical investigations are required​

MDR Art. 61(4) states that for implantable Class III devices and Class III devices, clinical investigations must be performed unless:

  • The device has been modified from a device already marketed by the same manufacturer, and
  • The modifications have been shown by clinical evaluation data not to significantly affect the safety and performance

In practice, for novel Class III devices with no genuine equivalent, a clinical investigation is expected.

See Clinical investigations.

The clinical evaluation and the lifecycle​

Clinical evaluation is not completed at CE marking — it continues post-market through PMCF. The CER must be updated:

  • Whenever significant new clinical data is available
  • At minimum annually for Class IIb and III devices
  • When PMCF data identifies new safety or performance findings
  • When the device is modified

The current CER and PMCF evaluation report are reviewed by the notified body at each surveillance audit.

Official references​

ReferenceDescription
MDR Art. 61Clinical evaluation requirements
MDR Annex XIV Part AClinical evaluation stages
MDR Annex XIV Part BPMCF requirements
MDCG 2020-5Clinical evaluation guidance
MDCG 2020-6 rev.2Guidance on CER
MDCG 2021-6Guidance on sufficient clinical evidence for legacy devices
EN ISO 14155:2020Good clinical practice for medical device investigations