Clinical and Performance Evaluation under EU-MDR – New CE Market Rules
Clinical evaluation of medical devices is a systematic and planned process that contributes to the continuous generation, collection, analysis and evaluation of clinical data on a particular device. That way, it also verifies the safety and performance including the clinical benefit of a device for its intended use just as indicated by the manufacturer. In the MDR, the scope and emphasis of the clinical evaluation is more important than in the MDD. The clinical evaluation is part of medical device development and must comply with the general safety and performance requirements (GSLA) so that the device can be approved, and CE marked. This means that every medical device manufacturer has to go through this process with his device.
The main objective of any clinical evaluation is to demonstrate the safety and performance of a medical device in its clinical use. As a part of the conformity assessment procedure to obtain the CE marking it is an important process. Apart from the MDR, there are some guidelines/standards that must be observed when creating a clinical evaluation, such as the MEDDEV 2.7/1 Rev. 4 (2016), MDCG 2020-5 and 2020-6 or requirements from the ISO 14155.
Clinical evaluation and the MDR
The clinical evaluation is regulated in MDR section 61 and annex XIV, the term on its own is also defined in the general definitions. The transition from MDD to MDR also has some impact on the clinical evaluation, but the clinical evaluation should continue to be created based on existing clinical data.
- Updating throughout the entire product life cycle is still required
- As a general rule for class III devices and implants, clinical data should be obtained from clinical investigations; the MDR allows for exemptions under certain conditions, for details see MDCG 2020-5.
- There is no exception for active implantable medical devices
- For class III devices and some class IIb devices an authority or an expert panel may be consulted in addition “with the aim of reviewing the intended clinical development strategy and proposals for clinical investigation.” (Article 61, Subparagraph 2 MDR)
The MEDDEV 2.7/1 Rev. 4 (2016) and MDCG 2020-5 and 2020-6 as guidelines
The implementation of the requirements for the clinical evaluation is performed along the guideline of the MEDDEV 2.7/1 Rev. 4 (2016) as well as the MDCG Guidance’s 2020-5 and 2020-6. These guidelines are commonly recognized by the notified bodies and outline strict requirements for the demonstration of safety and performance of medical devices, as well as the equivalence of devices and clinical data on legacy devices. An important aspect is the continuous update of data throughout the entire product life cycle!
According to the guidelines, the clinical evaluation should observe the following steps:
- Step 0: Planning
explain objective and structure of the clinical evaluation, classification of product development (known/new technology, new application), intended use - Step 1: Identification
collecting clinical data, equivalence, possible sources: academic literature, clinical experience, clinical investigation - Step 2: Assessment
individual data evaluation, assessment according to defined criteria (Is the source reliable? Does the source give information on benefit and product safety?) - Step 3: Analysis
entire evaluation of the relevant data to assess whether proof of performance and safety of the medical device is given. Criteria: significance of data, conclusions on product benefit and safety; qualitative or quantitative evaluation is possible - Step 4: Report
Logically structured report on the evaluation including justifications and documentation of the steps, documents all individual steps (clinical evaluation report)
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