EU MDR CLINICAL EVALUATION
We are here for you every step of the way. With our support and advice, you can be confident of meeting your regulatory clinical evaluation requirements right from the start.
Our team can assist you with various clinical evaluation tasks, including:
- Build a clinical evaluation strategy aimed at waiving or reducing clinical investigations
- Write Clinical Evaluation procedure (SOP)
- Analyze and demonstrate equivalence to the comparator device
- Write or review the Clinical Evaluation Plan
- Write or review the Clinical Evaluation Report
- Write Literature Plan and Report
Could the company use the clinical data from a similar device during MDR clinical evaluation?
MDR does not define the term similar device. Instead, the clinical data definition mentions only the device in question and its equivalent device (MDR, Article 2(48)). MDCG 2020-6 Clinical Evidence needed for the legacy devices defines similar devices as those belonging to the same generic device group. The MDR defines a generic device group as a set of devices with the same or similar intended purposes or commonality of technology (MDR, Article 2(7).
MDCG 2020-6 states that it is vital to identify all available clinical data sources from both the pre-market and post-market phases, including all clinical data generated and held by the manufacturer and clinical data for equivalent or equivalent or similar devices. In addition, one of the proposed uses of similar devices’ clinical data mentioned in MDCG 2020-5 Clinical Evaluation – Equivalence (section 5) is to provide input for clinical investigation design or PMCF design and the PMS system.
MDR clearly states that Notified Body’s assessment of clinical evaluations should cover (among others): the validity of equivalence claimed concerning other devices, the demonstration of equivalence, and the suitability and conclusions data from equivalent and similar devices (Annex VII, 4.5.5; 4.10).
Further, according to MDR, the PMCF plan should include evaluating the clinical data relating to equivalent or similar devices (Annex XIV, Part B, 6.2(f)).
Based on this, we argue that clinical data from similar devices are subsumed in the last paragraph of MDR clinical data definition, for it is stated: clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up (as it is clarified in MDCG 2020-5 and 2020-6).
Thus, we can conclude that similar devices are a useful and important source of clinical data. For a more specific response, we need to review all pre-clinical & clinical data generated or identified for the product in case.
See 31 tips for Successful MDR Clinical Evaluation and CER here
Clinical Evaluation is an ongoing procedure to collect, appraise and analyze clinical data on a medical device or its equivalent to conclude whether sufficient clinical evidence exists for compliance with relevant General Safety and Performance Requirements (GSPR). Clinical Evaluation is required for all medical devices (MDR, Article 61).
Clinical Evaluation is part of manufacturer QMS and should be aligned with and reflected in Risk management, Post-market surveillance (PMS), Post-market clinical follow-up (PMCF) plan, and, where appropriate, the PMCF report, and Instructions for use.
The Notified Body’s expectations regarding the company’s clinical evaluation process and documentation are clearly presented in the guidance of the MDCG 2020-13 Clinical evaluation assessment report template (July 2020).
Clinical Evaluation is based on the company’s Clinical Evaluation Plan (see MDR Article 61 and Part A of Annex XIV).
A Clinical Evaluation Report (CER) summarizes the clinical evaluation methodology and results.
See our blog about Clinical evaluation here.
For more information, don’t hesitate to contact the BioReg team.
What clinical guidelines and standards are binding according to MDR & IVDR?
The text of the MDR (IVDR) is the only which is authentic in law – legally binding.
The Medical Device Coordination Group issues MDCG documents to assist stakeholders in effectively applying MDR and IVDR (as per Article 105 of the MDR and Article 99 of the IVDR).
So, although MDCG guidance are not legally binding, you should consider them since there are considered a “state of art” interpretation of MDR and IVDR requirements. At the moment, you will find a dozen documents related to the clinical investigation and Evaluation on the official European commission MDCG page.
Even though MEDDEV 2.7/1 Rev. 4 guidance is related to MDD, compliance with this guidance is expected in addition to MDR requirements when writing Clinical Evaluation Report (CER) and Literature search report. Some experts advised not citing this guidance in the CER list of standards but still following it. We prefer a more traditional approach – if you followed the standard, state so. In addition, you should review MDCG 2020-6, Appendix I for the sections of MEDDEV 2.7/1 rev. 4, which are specifically relevant under the MDR.
Do not forget ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice.
Regarding the standards in general, you should follow the most updated standard (even if it is not harmonized under MDR). You are expected to justify if you partially followed the updated standard or followed non-updated standard or guidance to demonstrate compliance with MDR.
Some Notified Bodies advised following the guidance documents in this descending order of significance: common specifications, harmonized standards (under MDR), and MDCG documents.
If you plan to write your first Clinical Evaluation Report (CER) and don’t know how to start – we advise you to use our CER template.
In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.