Key MDCG Guidance Documents for a Clinical Evaluation (EU MDR)

by | Jan 23, 2024 | Clinical Writing, IMed Consultancy, MDR

Key MDCG Guidance Documents for a Clinical Evaluation (EU MDR)

When producing a Clinical Evaluation for a medical device under the scope of the EU MDR 2017/ 745, MDCG guidance documents play a crucial role in enabling the manufacturer to demonstrate conformity to the regulation. This blog will introduce a number of MDCG documents that are often pivotal to a Clinical Evaluation for certain medical devices, and will describe both when and how you should use the guidance offered.

1. MDCG 2020-1: Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software.

When you may need it: when producing a Clinical Evaluation on a medical device software.

The MDCG 2020-1 guidance document provides a framework for the determination of the appropriate level of clinical evidence required for a Medical Device Software (MDSW) to fulfil the requirements set out in the EU MDR. Three key components are recognised to have to be considered when compiling clinical evidence for every MDSW:

  • Valid Clinical Association – understood as the extent to which, the MDSW’s output (e.g. concept, conclusion, calculations) based on the inputs and algorithms selected, is associated with the targeted physiological state or clinical condition. This association should be well founded or clinically accepted, e.g., through the State-of-the-Art Analysis. The valid clinical association of a MDSW should demonstrate that the principle with which it operates is expected to correspond to the clinical situation, condition, indication or parameter defined in the intended purpose of the MDSW.
  • Technical Performance – refers to the demonstration of the MDSW’s ability to accurately, reliably, and precisely generate the intended output, from the input data. Evidence supporting technical performance can be generated through verification and validation activities.
  • Clinical Performance – validation of a device’s clinical performance is the demonstration of a MDSW’s ability to yield clinically relevant output in accordance with the intended purpose. The clinical relevance of a MDSW’s output is a positive impact:
  • on the health of an individual expressed in terms of measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, prediction of risk, prediction of treatment response(s), or
  • related to its function, such as that of screening, monitoring, diagnosis, or aid to diagnosis of patients, or
  • on patient management or public health.

By evaluating the clinical evidence and data collated within the Clinical Evaluation Report (CER) against the criteria above, it can be determined whether there is an appropriate level of information in the CER to facilitate an evaluation against the GSPRs of the EU MDR.

2. MDCG 2020-5: Clinical Evaluation – Equivalence.

When you may need it: when using clinical evidence for a predecessor device to evaluate the safety and performance profile of the current device, or, for the application of clinical evidence on an alternative device on your own device.

Using the criteria laid out within the MDCG 2020-5, which refer to a device’s clinical, technical, and biological characteristics, you can evaluate whether two devices are equivalent to one another, meaning the devices share no expected difference in their safety and performance profile when used as intended in their clinical use environment. If demonstrated successfully, this will allow the Clinical Evaluation to consider evidence on the equivalent device as directly applicable to the device under evaluation, and subsequently may be the route with which manufacturers collect enough evidence to evaluate GSPR conformance, especially in instances whereby the amount and quality of evidence available on the device under evaluation itself is lacking.

Considerations of equivalence must always be based on proper scientific justification. For assuming equivalence, all three characteristics (clinical, technical, and biological) need to be fulfilled. The differences between the device under evaluation and the device presumed to be equivalent will be identified, fully disclosed, and evaluated in terms of impact on the clinical performance and clinical safety. Should the differences in characteristic be responsible for a clinical impact that cannot be addressed by means other than clinical investigations, the devices will not be considered as equivalent. Should the differences be associated with no expected clinical impact for any of the three features, equivalence will be considered as demonstrated, and clinical data generated with the demonstrated equivalent device will be used for clinical evidence.

3. MDCG 2020-6: Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC.

When you may need it: to achieve leniency in the level of clinical evidence required for your medical device under the condition that the device was previously placed on the market under MDD, classifies as a legacy device, and meets the criteria of a ‘Well-Established Technology’.

In instances where your medical device has a long history on the market and has been placed on the market under the Medical Device Directive (93/42/EEC), the device can be classified as a legacy device as per MDCG 2020-6. When a device is classified as a legacy device, the level of clinical evidence needed for the device to meet requirements of the EU MDR can be understood to be more lenient, under the condition that this device can be identified as a ‘Well-Established’ Technology’ (WET). The criteria that can be used to determine whether the device under evaluation can be defined as a WET is also set out in the MDCG 2020-6 document:

  • Relatively simple, common, and stable designs with little evolution.
  • Generic device group has well-known safety and has not been associated with safety issues in the past.
  • Well-known clinical performance characteristics and the generic device group are standard of care devices where there is little evolution in indications and the state of the art.
  • A long history on the market.

If the devices under evaluation are not Class III legacy devices or implantable legacy devices, but can be recognised as a ‘Well-Established Technology’, a device is able to evaluate their conformity with the relevant GSPRs as part of the Clinical Evaluation Report using the cumulative evidence from a number of additional sources:

  • Equivalence data
  • Evaluation of state of the art, including evaluation of clinical data from similar devices
  • Complaints and vigilance data; curated data
  • Proactive PMS data, such as that derived from surveys
  • Individual case reports on the subject device
  • Compliance to non-clinical elements of common specifications considered relevant to device safety and performance
  • Simulated use/ animal/ cadaveric testing involving healthcare professionals or other end users
  • Pre-clinical and bench testing/ compliance to standards

By using this MDCG guidance document and through the consideration of these sources, the emphasis on the need and use of direct clinical evidence on the device under evaluation itself within the CER is reduced. This guidance document serves to ensure that in instances whereby a device is well-established within the medical field and has a long history of use, for example surgical forceps which have been used for decades as part of surgical procedures, that the manufacturer is not required to launch unnecessary clinical investigations or PMCF activities for a technology that has a somewhat proven and assured clinical profile.

Do you need help figuring out which MDCG guidance documents should you use in drafting your Clinical Evaluation? Contact us at hello@imedconsultancy.com

Jacob Tyson

Jacob Tyson

Medical Writer

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