With the stricter European Regulations (MDR 2017/745) coming into full effect in 2020, the subject of clinical evaluation has become a sore point for medical device manufacturers. Regardless of their risk class, all Medical Devices marketed in Europe are subject to the clinical evaluation process, pursuant to section 6a of Annex I to Directive 2007/47/EC. Gone are the days when the Clinical Evaluation Report (CER) alone was enough.
Once considered just one element of the Technical File, the CER according to latest version of MEDDEV 2.7/1 (rev.4) is, in fact, only the final and conclusive stage of a thoroughly planned clinical evaluation process. Even if their products are already CE marked, manufacturers must keep up with increasingly higher standards because the scrutiny of the Notified Bodies (NBs) around clinical evaluation and CERs will only intensify as 2020 approaches.
MEDDEV 2.7/1 rev.4 defines the clinical evaluation as a procedure involving the collection, appraisal, analysis, and evaluation of the available clinical data to support the compliance of the medical device with the Essential Requirements (ERs). In other words, the clinical data serves as proof that, if used according to the manufacturer’s IFUs, the medical device it is safe, performs as claimed and any undesirable side effects are deemed acceptable when weighed against the clinical benefit of the device.
So, how can manufacturers make sure that their clinical evaluation process and CERs meet the latest regulatory expectations expressed in MEDDEV 2.7/1 rev.4?
Here are some useful ideas to take into consideration:
- Define clear CER objectives. Identify the pertinent ERs that need to be supported by clinical evidence (based on the device specifications) and define the scope of the clinical evaluation, meaning the specific and measurable objectives relative to safety, performance, and risk/benefit endpoints;
- Define whether a clinical investigation is required. Make sure the available clinical evidence is sufficient and adequate to address all the pertinent ERs. As a rule of thumb, high risk and Class III devices are always required to undergo clinical investigation, as well as those based on innovative or unproven technologies and those claiming a new clinical use;
- Prepare a bulletproof Demonstration of Equivalence. Based on the comparison between the subject device and several CE-marked equivalent devices available on the market, the demonstration of equivalence is assessed in terms of clinical, technological and biological parameters (defined by the manufacturer) and needs to be fully detailed in the CER. To provide an adequate equivalence demonstration, thoroughly documented information on each equivalent device is required. Additionally, the differences between the subject device and equivalent devices need to be identified, disclosed, evaluated and justified;
- Monitor post-market activities (PMS and PMCF). Plan an adequate PMCF, document all the conclusions in the CER, and make sure to have the PMS and PMCF processes in place. These are meant to be “living” documents because the safety and the performance of a device must be confirmed throughout its entire lifecycle;
- Update the CER frequently. Define the CER update frequency and justify it. The CER is a “living” document as well and so, whenever new post-market surveillance data that could affect the CER conclusions surfaces, it needs to be revised. Moreover, changes in the state-of-the art and current knowledge on equivalent devices should trigger a CER overhaul. The devices used for comparison should be kept relevant at all times.
Under the stricter MDR requirements reflecting the high expectations of the European Commission, NBs will challenge both the clinical evidence quality (therefore the criteria including such data in the clinical evaluation) and the foundation for establishing the equivalence with another device. The stakes are high: they must ensure that only safe and effective high-quality Medical Devices enter the European market.
The manufacturers preparing for the new legislation have MEDDEV 2.7/1 rev.4 at their disposal to act as a roadmap and guide their transition. CERs based on clinical equivalence demonstration alone will no longer be enough, particularly for high-risk devices, which are very likely to require clinical investigations. Only by aligning and integrating the CER with risk management, vigilance, and post-market surveillance activities, will compliance be achieved under the European MDR.
Otilia Maya Tanase, PhD
Regulatory Affairs & Marketing Specialist
- MEDDEV 2.7/1 rev.4 Clinical evaluation: a guide for manufacturers and notified bodies under directives 93/42 and 90/385;
- Medical Device Directive 93/42/EEC amended by Directive 2007/47/EC;
- Medical Device Regulations (EU) 2017/745.
Thema is passionately dedicated to saving lives and preserving the health of men, women, children and animals. Our professionals are by your side, ready to support you for:
- Developing a new Clinical Evaluation Plan (Stage 0);
- Updating the QMS documentation relative to the Clinical Evaluation;
- Conducting a gap analysis of MEDDEV guidelines vs. your existing CER;
- Preparing or updating your existing CER in compliance with MEDDEV 2.7/1 rev.4.
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