MDR clinical evaluation: what Article 61 really requires

Clinical evaluation is one of the most structuring requirements of the MDR 2017/745. It concerns every manufacturer, whatever the device class, and is a living document, not a one-off exercise. Here is what Article 61 actually requires, and how to approach it without getting lost.

Why MDR clinical evaluation differs from the Directive

Under Directive 93/42/EEC, clinical evaluation often came down to a brief literature review. The MDR changed the game on three points:

1. Equivalence became restrictive: it is demonstrated simultaneously on technical, biological and clinical characteristics (Annex XIV, Part A, section 3). For an implantable or class III device, claiming equivalence with another manufacturer's device also requires a contract giving full, ongoing access to its technical documentation (Article 61(5)).
2. Clinical evaluation is updated continuously with post-market clinical follow-up data. For class III and implantable devices, the PMCF evaluation report and, where indicated, the SSCP are updated at least annually (Article 61(11)).
3. PMCF becomes the rule: a manufacturer who considers it unnecessary must justify this in its post-market surveillance plan (Annex XIV, Part B).

What Article 61 sets out

• Clinical evaluation follows a defined and methodologically sound procedure and relies on sufficient clinical data to demonstrate conformity with the general safety and performance requirements (Article 61(1) and (3)).
• For implantable and class III devices, clinical investigations are performed, except in the cases of Articles 61(4) to (6): modification of the same manufacturer's device with equivalence demonstrated and endorsed by the notified body, equivalence with another manufacturer's device under a data-access contract, or devices lawfully placed on the market under the Directive with sufficient clinical data.
• Article 61(6) also exempts certain well-established devices: sutures, staples, dental fillings, braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.
• For class III implantable devices and class IIb active devices intended to administer or remove a medicinal product, a clinical evaluation consultation procedure with an expert panel is added to the notified body assessment (Article 54).

The Medical Device Coordination Group has detailed these requirements in several documents:

• MDCG 2020-5: clinical equivalence
• MDCG 2020-6: sufficient clinical evidence for legacy devices
• MDCG 2020-7 and MDCG 2020-8: PMCF plan and PMCF evaluation report templates
• MDCG 2020-13: the clinical evaluation assessment report template used by notified bodies

The three sources of clinical data

1. Device-specific data

The strongest source: results of clinical investigations on the device, post-market surveillance and PMCF data, documented clinical experience.

2. Equivalence

You demonstrate that your device is equivalent to another for which clinical data exist, on three simultaneous dimensions:

Dimension	What must be demonstrated
Technical	Similar design, conditions of use, specifications and properties, principles of operation and critical performance requirements
Biological	Same materials or substances in contact with the same tissues or body fluids, for a similar kind and duration of contact
Clinical	Same clinical condition or purpose, same site in the body, similar population, same kind of user, similar expected performance

⚠️ Critical point: for an implantable or class III device, equivalence with another manufacturer's device is only admissible with a contract giving full, ongoing access to its technical documentation. In practice, few manufacturers obtain one, which steers most towards their own data.

3. Scientific literature

Literature review remains admissible, but it must be methodical: documented search protocol, databases queried, inclusion and exclusion criteria, appraisal of study quality and relevance. A handful of abstracts is no longer enough.

The structure of a clinical evaluation report (CER)

The MDR sets the requirements (Annex XIV) without imposing an outline. Most manufacturers still follow the structure of MEDDEV 2.7/1 revision 4, adapted to MDR requirements:

1. Scope: device description, intended purpose, indications, target population, users
2. Clinical evaluation plan: method, data sources, acceptance criteria, expected clinical benefits
3. Data analysis of safety and performance: preclinical data, own or equivalent clinical data, literature
4. Equivalence analysis, where applicable, on the three dimensions
5. Benefit-risk assessment, consistent with ISO 14971 risk management
6. Conclusions: sufficiency of clinical evidence, residual uncertainties
7. PMCF plan, or justification for its absence
8. References

ISO 14155, often wrongly cited here, does not govern the CER: it sets good clinical practice for clinical investigations.

PMCF: clinical evaluation after market entry

Annex XIV, Part B, describes PMCF as a continuous process that updates the clinical evaluation. Its methods may be general (gathering clinical experience, literature review, surveillance data) or specific: follow-up studies, registries, user surveys.

PMCF results feed the PSUR for class IIa, IIb and III devices, and the post-market surveillance report for class I.

The link with the SSCP

For implantable and class III devices, the SSCP (summary of safety and clinical performance, Article 32) is mandatory. Validated by the notified body and published in EUDAMED, it summarises for users and, where relevant, patients:

• the device's clinical performance;
• residual risks, undesirable side-effects and warnings;
• the conclusions of the clinical evaluation and PMCF.

It is updated at least annually with PMCF data (Article 61(11)), and is drafted directly from the CER.

Mistakes notified bodies frequently raise

1. A frozen CER, when it should evolve with PMCF and surveillance data
2. Incomplete equivalence: the biological dimension is often neglected
3. A missing or vague PMCF plan, with no timeline, method or owner
4. Literature without a protocol, with no justification for the studies selected
5. Evaluators whose qualifications are not demonstrated: the MDR requires the evaluation to be carried out by suitably qualified persons

What MedQara monitors for you

Clinical evaluation rules evolve regularly:

• MDCG documents on clinical evaluation, equivalence and PMCF;
• common specifications published for certain device families;
• expert panel opinions issued in the consultation procedure;
• changes to transition rules for legacy devices.

The platform automatically ranks these publications by criticality and provides a contextual analysis of each, across 64 sources including 49 official authorities and institutions.

Need structured monitoring of clinical evaluation and PMCF? Try MedQara for free, no credit card required.