The European regulatory landscape has significantly changed over the past 10 years, particularly concerning requirements for Clinical Evaluation (CEP/CER).
This fits well with the definition of ‘clinical data’ in Article 2(48), which implies that the purpose of the clinical evaluation is ‘to verify the clinical safety and performance, including clinical benefits, of the device when used as intended by the manufacturer’.
MDD (93/42/EEC) Article 2 of the MDD states: “Intended | MDR 2017/745 In the MDR 2017/745 intended purpose |
The requirements from Article 61 and Annex XIV of the EU MDR with the additional clarifications provided by guidance such as MDCG 2020-5 and 2020-6, the clinical evaluation must also:
Clearly identify the intended purpose and associated clinical benefits of the device(s) as well as the conditions of use and specific contraindications, in a way that the available clinical evidence can justifiably support.
Establish outcomes achievable with other state of the art (SOTA) therapies for the same patient populations and treatment indications to determine benchmarks for safety, performance and benefit-risk of the subject device:
- Justify the sources of data used, including the use of equivalence and non-clinical evidence, if applicable
- Conclude not only regarding performance, clinical safety and benefit-risk, but justify the completeness of the evidence to support:
- All indications (including those implied by broad intended purpose statements)
- All potential patient populations regarding high-risk devices
- All device variants, combinations and accessories if applicable
- Usage with accessories and other devices, where applicable
- Device lifetime in clinical conditions of use
- Risk identification/confirmation of risks identified through the manufacturer’s risk management processes
- Acceptability of residual risks
It is essential to identify these parameters to demonstrate that a medical device achieves its intended purpose, clinical safety, and benefits. The manufacturer needs to state how those parameters can be measured or indicated (i.e., what the associated objectives/endpoints are), and what acceptable outcomes look like (i.e., similar benchmarks or performance measures).
To do this, it is necessary to start with a clear and comprehensible description of the medical device’s intended purpose, indications and a specification of the standard of care for that intended purpose (state of the art).
The definition of the intended purpose and indications for use of the device is a fundamental step that describes all the following aspects of the clinical evaluation.
It helps to define the following:
- The objectives of the clinical evaluation
- The evaluation of sufficient clinical data for the demonstration of clinical evidence
- Criteria for selection of SOTA devices and therapies
- The scope of literature searches
- The scope of the risk evaluation
Although Article 2(12) of the MDR provides the same definition of »intended purpose« as the former Directives, Annex I Section 23.4 confirms that the intended purpose includes indications, where these exist:
The IFU should contain all the following points:
- (b) the device’s intended purpose with a clear specification of indications, contra-indications, the patient target group or groups, and the intended users, as appropriate
It is important to note that not all devices have indications, as clarified by the definition of »indication« in MDCG 2020-6:
´indication´ or ´indication for use´: refers to the clinical condition to be diagnosed, prevented, monitored, treated, alleviated, compensated for, replaced, modified or controlled by the medical device. It should be distinguished from »intended purpose/intended use« which describes the effect of a device. All devices have an intended purpose, but not all devices have an indication (e.g., medical devices with an intended purpose of disinfection or sterilisation of devices).
At the same time, considering that the scope of the clinical evaluation is determined according to the “(…)nature, classification, intended purpose and risks of the device in question, as well as to the manufacturer’s claims in respect of the device”, any statements that appear in the labelling, IFU and promotional materials must be included in the current CER.
“In the labelling, IFU, making available, putting into service and advertising of devices, it shall be avoided to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient related to the intended purpose, safety and performance of the subject device“.
If a device has indications, confirmation of conformity with the relevant General Safety and Performance Requirements (GSPRs) of Annex I must include clinical data relating to these indications.
Annex XIV Section 1a specifies that the clinical evaluation plan must include:
- A clear specification of the intended target treated population with clear indications and contra-indications and
- An indicative list and specification of parameters to be used to determine, based on SOTA, the acceptability of the benefit-risk ratio for the various indications and the intended purpose or purposes of the device.
It is important to note that broad intended purpose statements will not be satisfactory for most devices under the MDR.
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