OUR SERVICES

 

WHAT WE DO BEST

We Provide comprehensive support and guidance in preparation of Clinical and Performance Evaluation Reports, Systematic Literature Search, State of the Art, Scientific Validity, Analytical Performance, and Clinical Performance Reports for devices. Requalite is proud to be house of expert Medical Writers with strong scientific background in Medical Device and In vitro diagnostic fields.

Regulatory Consulting

We consult manufacturers of IVDs and Medical devices on the planning, preparation, execution, and reporting of all required technical documentation for existing as well as novel devices to ensure the compliance with EU IVDR and EU MDR. We provide services for planning, writing, and documentation of evaluations and reports provisioned in IVDR. This includes:

  • Clinical Evaluation Plan (CEP)
  • Clinical Evaluation Report (CER)
  • Performance Evaluation Plan (PEP)
  • Performance Evaluation Report (PER)
  • Literature Search Plan (LSP)
  • Literature Search Report (LSR)
  • Analytical Performance Report (APR)
  • Clinical Performance Report (CPR)
  • State of the Art (SOTA)
  • Post-market Surveillance (PMS) Plan
  • Post-market Surveillance (PMS) Report
  • Periodic Safety Update Report (PSUR)
  • Post-market Performance Follow-up (PMPF) Plan
  • Post-market Performance Follow-up (PMPF) Report
  • QMS in accordance with ISO13485
  • RMS in accordance with ISO14971

 

We also provide resources for the manufacturers in helping them navigate the system, keep current with the changes in the regulation, and train their personnel responsible for regulatory and quality compliance.

Quality Management Consulting

Requalite can help you establish your Quality Management System (QMS) according to ISO 13485 and in compliance with MDR and IVDR to bring your medical devices into European market safely. Please contact us for further details.

Performance Evaluation Report

 

What is Performance Evaluation Report (PER) ?

 To get CE approval for an in vitro diagnostic device, the manufacturer assesses all relevant scientific validity, analytical and clinical performance data to verify the conformity of its device with the general safety and performance requirements. The amount and quality of that data allow the manufacturer to make a qualified assessment of whether the device will achieve the intended clinical benefit or benefits and safety when used according to its intended purpose. The data and conclusions drawn from this assessment constitute the clinical evidence for the device. The clinical evidence scientifically demonstrates that the intended clinical benefit or benefits and safety will be achieved according to the state of the art in medicine.

 The clinical evidence is derived from the scientific validity data, the analytical performance data and the clinical performance data, and their assessment. The clinical evidence shall be such as to scientifically demonstrate, by reference to the state of the art in medicine, that the intended clinical benefit(s) will be achieved and that the device is safe. The clinical evidence derived from the performance evaluation provides scientifically valid assurance, that the relevant general safety and performance requirements are fulfilled under normal conditions of use.

 

 

The performance evaluation report (PER) is the document in which the clinical evidence is presented. The notified body reviews the clinical evidence provided by the manufacturer in the PER. This report includes the scientific validity report, the analytical performance report, the clinical performance report, the PMPF report (if available) and an assessment of those reports allowing demonstration of the clinical evidence.

The PER, in particular, includes the justification for the approach taken to gather the clinical evidence;  the literature search methodology and the literature search protocol and literature search report of a literature review; the technology on which the device is based, the intended purpose of the device and any claims made about the device’s performance or safety;  the nature and extent of the scientific validity and the analytical and clinical performance data that has been evaluated; the clinical evidence as to the acceptable performances against the state of the art in medicine;  and any new conclusions derived from PMPF reports.

 PER is updated throughout the life cycle of the device concerned with data obtained from the implementation of the manufacturer’s PMPF plan as part of the performance evaluation and the post-market surveillance system. PER is a part of the technical documentation of the device.

 

 

 

Clinical Evaluation Report

 

What is a Clinical Evaluation Report (CER)?

 

European Union (EU) Medical Devices Regulation (MDR) (MDR 2017/745) requires that all medical devices are evaluated for its clinical performance, whether the device performs as intended in clinical settings. Clinical evaluation refers to the continuous process of collecting, appraising, and analyzing the clinical data related to a medical device. A medical device’s clinical evaluation and the clinical evidence derived from this evaluation are documented in a clinical evaluation report (CER). The CER is a part of the technical documentation submitted by the manufacturer to the Notified Body during the approval process for CE marking, a requirement for devices to be marketed in the EU.

 

The CER

  • demonstrates the equivalence of the device in question to an existing certified device (if claimed),
  • presents the clinical data from the manufacturer and/or the literature,
  • appraises the clinical data, and
  • analyzes the clinical data for safety, benefit/risk profile, performance, acceptability of side-effects

 

The structure of a typical CER for a medical device is laid out in the Guidelines on Medical Devices (MEDDEV 2.7/1 Rev. 4), published as a guideline by the European Commission.

 

Note for PERs: Since there is no exclusive guideline for the performance evaluation report (PER) mandated in the In Vitro Diagnostic Regulation (IVDR 2017/746, counterpart of MDR for in vitro diagnostics devices – IVDs), PERs follow the guidelines provisioned for CERs.

 

Literature Search Report

The literature search plays a critical role in the performance evaluation. A systematic literature search on the device under evaluation contributes to demonstrating scientific validity, analytical performance, and clinical performance, which are the three pillars of the performance evaluation. Additionally, preparation of the PMPF plan also requires screening of scientific peer-reviewed literature.

As a general methodological principle, the manufacturer identifies the data through a systematic literature review relating to the safety, clinical benefits to patients, design characteristics, scientific validity, clinical and analytical performance, and intended purpose of the device and/or equivalent similar devices.

The search and the literature review protocol should specify the background and purpose of the review. The review protocol includes the methods of searching, determining, selecting, collecting, and appraising the gathered scientific literature. The selection of literature should be objective and justified, i.e. include all relevant favorable and unfavorable data.

A literature search report should be prepared following the search to present the execution, any deviations from the literature search protocol, and the search results. The adequacy of the searches should be verified. The performance evaluation report includes the literature search methodology and the literature search protocol, and the literature search report of a literature review. The assessment by notified bodies of procedures and documentation addresses the results of literature searches. The notified body’s assessment of performance evaluations referred to in Annex XIII covers relevant documentation from the literature search report and the literature search methodology. The notified body conducts an in-depth review of the performance evaluation based on clinical literature relevant to the condition being treated with the device or clinical literature relevant to similar devices.

MEDDEV 2.7/1 Revision 4, A5 provides general guidance on the literature search and gives information about how to do a literature search, literature review, and document for the clinical evaluation.

Post-market Surveillance Report

What is a Post-Market Surveillance Report (PMSR)?

 Post-Market Surveillance (PMS) is the continuous, active and systematic process of gathering, recording and analysis of relevant data on the quality, performance and safety of a medical device (MD) (including in vitro diagnostics devices – IVDs) throughout its entire lifetime. The PMS is conducted by the manufacturer within the framework of a PMS plan (PMSP). Post-Market Surveillance Report (PMSR) is the document that summarizes the results and conclusions derived from the analysis of the PMS data. The PMSR also includes the description of any preventive and corrective actions taken as a result of incidents related to the MD. PMSP and PMSR are a part of the technical documentation on PMS for a device.

According to the European Union (EU) Medical Devices Regulation (MDR) (MDR 2017/745), manufacturers of class I MDs are required to prepare a PMSR, to update when necessary, and to make available to the competent authority upon request. Similarly, manufacturers of class A and B IVDs are required to prepare, update, and make available the PMSR for their IVD according to the In Vitro Diagnostic Regulation (IVDR 2017/746).

 

Periodic Safety Update Report (PSUR)

What is a Periodic Safety Update Report (PSUR)?

A continuous process of Post-Market Surveillance (PMS) produces data on the quality, performance and safety of a medical device (MD) (including in vitro diagnostics devices – IVDs) throughout its entire lifetime. According to the European Union (EU) Medical Devices Regulation (MDR) (MDR 2017/745), manufacturers of class IIa, IIb, and III MDs are required to prepare a Periodic Safety Update Report (PSUR) for each device, or each category or group of devices, to summarize the results and conclusions derived from the analysis of the PMS data, including the benefit-risk determination, main findings of the post-market clinical follow-up (PMCF), and market statistics (i.e., volume of sales, size of the population using the device, and the frequency of use). PSUR is a part of the technical documentation on PMS for a device.

Manufacturers of class IIa devices must update the PSUR when necessary and at least every two years. Manufacturers of class IIb and III devices must update the PSUR when necessary and at least annually. Manufacturers of class III devices and implantable devices must submit the PSUR through the electronic system on vigilance and on PMS, others must make it available for the notified body involved and the competent authorities.

Similarly, manufacturers of class C and D IVDs are required to prepare and update PSURs for these IVDs according to the In Vitro Diagnostic Regulation (IVDR 2017/746). PSURs for IVDs should incorporate the main findings of the post-market performance follow-up (PMPF). Manufacturers of class C and D IVDs must update the PSUR when necessary and at least annually. Manufacturers of class D IVDs must submit the PSUR through the electronic system on vigilance and on PMS, others must make it available for the notified body involved and the competent authorities.

.

Training

We can provide IVDR, MDR, QMS technical documentation training to your Regulatory teams and help them create customised report templates that can be utilised in all the products.” Please use contact form to get in touch with us to learn more about training opportunities!

Gap Analysis

 

Requalite can provide you a comprehensive Gap Analysis for your product in readiness for compliance process and help identify potential improvement model and approach for a stress- and failure-free Conformity Assessment event.

EU Authorised Representative (EC REP)

Requalite can provide the non-European manufacturers an authorised representative service, EC REP, as their point of contact with notified bodies and competent authorities within Europe in obtaining of CE-marking, This is described in IVDR as following: “For manufacturers who are not established in the Union, the authorised representative plays a pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person established in the Union. Given that pivotal role, for the purposes of enforcement it is appropriate to make the authorised representative legally liable for defective devices in the event that a manufacturer established outside the Union has not complied with its general obligations.