MDR Clinical Evaluation: definitions
EU Regulation 2017/745, commonly referred to as Medical Device Regulation (MDR), requires the assessment of the safety and performance of the device under its intended use through the compliance of the General Safety and Performance Requirements (GSPR). According to the Medical Device Regulation (MDR) article 61, the assessment of safety and performance shall be done with the clinical evidence, obtained from the clinical evaluation of the clinical data. The information collected from the clinical evaluation process is assessed and documented in a report called the clinical evaluation report (CER).
MDR definitions for clinical evaluation, clinical data, and clinical evidence.
Clinical evaluation
means a systematic and planned process to continuously generate, collect, analyze and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer
Clinical evidence
means clinical data and clinical evaluation results pertaining to a device of sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s) when used as intended by the manufacturer
Clinical data
means information concerning safety or performance that is generated from the use of a device and is sourced from the following:
– clinical investigation(s) of the device concerned,
– clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated,
– reports published in the peer-reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated,
– clinically relevant information coming from post-market surveillance, in particular, the post-market clinical follow-up
MDR Clinical Evaluation: requirements and clinical data
The MDR article 61 and annex XIV specifies the requirements for the Clinical Evaluation process. The clinical data in the CER shall provide sufficient clinical evidence, and the level of clinical evidence depends on the characteristics and intended purpose of the device.
The required level of (sufficient) clinical evidence is defined by the risks associated to the use of the device under evaluation and its classification.
The clinical evaluation shall follow a defined and methodologically sound procedure which includes the critical evaluation of the existing:
- Scientific literature on the device under evaluation or an equivalent device
- Clinical investigations using the device under evaluation
- Alternative treatment options for that purpose
One of the most frequently asked questions is whether a clinical investigation is always required. For lower-class devices, enough clinical evidence can be obtained from the scientific literature, the results of non-clinical testing methods (usability, bench and pre-clinical testing), and the risk management to provide proof of compliance with the applicable GSPR without a clinical investigation.
Clinical investigations are not always required.
For implantable and class III devices, although a clinical investigation is generally required. A few exceptions can be found in the MDR (article 61 sections 4 to 6) and are summarised below:
- Manufacturers of devices placed on the market under AIMDD or MDD and for which there is sufficient clinical data;
- Manufacturers of devices for certain well-established technologies;
- Manufacturers of devices with an equivalent device placed on the market by the same manufacturer for which there is a sufficient clinical evaluation;
- Manufacturers of devices with demonstrated equivalence to a device placed on the market by another manufacturer for which there is sufficient clinical data(a contract between both manufacturers is required).
The clinical evaluation is a live document that has to be updated periodically throughout the life cycle of the device, to include data from post-market clinical follow-up (PMCF) studies.
Additional guidance on how to follow the MDR requirements is provided on the MDCG guidelines MDCG 2020-5, MDCG 2020-6, and MDCG 2020-13.
MDR Clinical Evaluation: major changes
Compared to the MDD, CER requirements under MDR have gained importance. However, when compared with the MEDDEV 2.7/1 revision 4, the requirements are similar. Some changes worth mentioning:
- The MDR includes the concept of expert panel consultation for manufacturers of class III and IIb devices.
- The CER has to include a summary Clinical Evaluation Plan
- Increased emphasis on clinical investigations (as detailed in the previous section)
- The requirements to claim equivalence vary slightly from the MEDDEV requirements (AKRN is preparing a separate whitepaper discussing this topic and the MDCG 2020-5)
- Clinical evidence for the evaluated device has to be compared to alternative devices to determine safety and performance
- Essential Requirements are substituted by GSPR
Experts in CER development and MDR
AKRN specializes in Clinical Evaluation Report development compliant with the Regulation (EU) 2017/745. As part of our regulatory services, AKRN can assist medical device manufacturers to fulfil the requirements needed to develop a CER for your new medical device.
We can also assist your company with the update of the CER to an MDR compliant document for an existing medical device. Our regulatory experts at AKRN can perform MDD to MDR gap assessments, provide guidance to complete a CER transition from MDD or MEDDEV 2.7/1 revision 4 to the new MDR, and develop required documentation (literature review reports, clinical evaluation plan, clinical evaluation reports, etc) adapted to your needs.
