Regulatory Affairs Consulting for Medical Devices
Regulatory Affairs Consulting for Medical Devices
Key elements of the IVDR are the significant reinforcement of the risk classification, clinical evaluation, conformity assessment procedures, vigilance, and post-market surveillance while ensuring transparency and traceability. Due to the extended requirements for documenting the quality and conformity of the medical devices imposed by MDR, many manufacturers seek professional help in preparing the necessary documentation. The specific requirements of the documentation for MDR are set in the main body and annexes of Regulation (EU) 2017/745. Our experts at New Criteria Consulting can help you prepare the necessary documentation and provide technical consulting during this process.
The initial step for demonstrating compliance is to go through the General Safety and Performance Requirements (GSPRs) that need support from clinical data. These requirements are explained in Annex I of the MDR regulation (Regulation (EU) 2017/745). GSPRs are the basic requirements that are necessary to demonstrate the safety and performance of the devices. GSPRs need to be supported by performance evaluation and clinical data and need to be documented according to the MDR.
To effectively clinically evaluate any device, the first document that needs to be prepared is the Clinical Evaluation Plan (CEP). To plan, continuously conduct, and document a clinical evaluation, manufacturers shall establish and update a clinical evaluation plan. For medical devices, the manufacturers shall plan, conduct and document a performance evaluation in accordance with the Annex XIV of MDR. The clinical evidence that is documented should be able to support the intended purpose of the device as stated by the manufacturer and be based on a continuous process of clinical evaluation, following a clinical evaluation plan. According to the MDR, the clinical evaluation should follow a defined and methodologically sound procedure that is demonstrated by the scientific validity, identification of the general safety and performance requirements, identification of available clinical data relevant to the device and its intended purpose and any gaps in clinical evidence through a systematic scientific literature review, and properly designed clinical investigations in accordance with the clinical development plan.
Clinical Evaluation Report is a core requirement of the Medical Device Regulation (MDR). Clinical evaluation is a methodologically sound procedure to collect, appraise and analyze clinical data about a medical device and to analyze whether there is sufficient clinical evidence to confirm the essential requirements for safety and performance when using the device according to the manufacturer’s instructions for use. The Clinical Evaluation Plan will form the basis of the Clinical Evaluation Report (CER) which is described in MDR Annex XIV. The clinical evidence should be documented in the Clinical Evaluation Report, which should include the scientific validity report, and a comprehensive analysis of available pre and post-market clinical data relevant to the intended purpose of the device in question, including clinical performance data and clinical safety data.
The scientific validity of the device should be demonstrated by a Scientific Validity Report (SVR) that identifies the available data relevant to the device and its intended purpose through a systematic scientific literature review and identify any remaining unaddressed issues or gaps in the data and appraise all relevant data by evaluating their suitability for establishing the safety and performance of the device.
The Clinical Evaluation Plan should also include a Literature Search Plan (LSP) which explains the literature search methodology that will be applied when performing the literature search and writing the Literature Search Report (LSR).
The SSCP is intended to provide public access to an updated summary of clinical data and other information about the safety and clinical performance of the medical device. The information in the SSCP should be sourced entirely from the technical documentation of the device. The SSCP shall be kept updated in Eudamed. The SSCP shall be objective and adequately summarise both favorable and unfavorable data.
The clinical evaluation of a device should be performed through a clinical investigation that will be performed in accordance with the ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice. These studies should be performed after obtaining an Internal Review Board approval. In order to apply for approval of such as study, the application forms should accompany Clinical Investigation Plan (CIP) and Investigator’s Brochure (IB). A clinical investigation plan is a document that states the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct, and record-keeping of the clinical investigation. The investigator's brochure (IB) shall contain the information on the device for performance study that is relevant for the study and available at the time of application. Clinical investigations should be performed on the basis of a clinical investigation plan (CIP). The CIP should clearly define the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct, and record-keeping of the clinical investigation as explained in Annex XV of the MDR.
As per Annex XV of the MDR, the Clinical Investigation Report (CIR) should be signed by a medical practitioner or any other authorized person responsible and contain documented information on the clinical investigation plan (CIP), and results and conclusions of the clinical investigation, including negative findings. It is imperative that the results and conclusions are presented transparently, free of bias, and clinically relevant. The CIR shall contain sufficient information to enable it to be understood by an independent party without reference to other documents and include as appropriate any protocol amendments or deviations, and data exclusions with the appropriate rationale.
Post-Market Clinical Follow-Up (PMPF) is a continuous process that updates the clinical evaluation and that shall be addressed in the manufacturer’s post-market surveillance plan as stated in part B of Annex XIV of the MDR. The manufacturer shall analyze the findings coming from the activities foreseen in the PMCF plan and document the results in this PMCF evaluation report which should be part of the clinical evaluation report and the technical documentation. Before conducting PMCF, the methodology should be documented in a PMCF plan. PMCF should be conducted by the manufacturer by proactively collecting and evaluating clinical and relevant scientific data from the use of the device with the aim of confirming the safety, performance, and scientific validity throughout the expected lifetime of the device. Its purpose is to ensure the continued acceptability of the benefit-risk ratio and detect emerging risks on the basis of factual evidence.
For each device, manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device. The requirements for the PMSP documentation are detailed in Annex III of the Medical Device Regulation (EU) 2017/745 (MDR). Manufacturers shall prepare a post-market surveillance report (PMSR) summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan together with a rationale and description of any preventive and corrective actions taken.
The manufacturer shall prepare a periodic safety update report (PSUR) that includes data gathered as a result of the post-market surveillance plan, a description of any preventive and corrective actions taken, conclusions of the benefit-risk determination, and the main findings of the PMCF. If the PSUR contains information rendering any information in the SSCP incorrect or incomplete, the SSCP shall be updated to be in line with the information in the most recent PSUR. The manufacturer shall submit a PSUR to the Notified Body at least annually, or for class IIa implantable devices at least every two years according to MDCG 2019-9 Rev.1.
