The evidence-based approach is getting more and more important not only for regulatory purposes but also for marketing medical devices. It is always asked to provide evidence to demonstrate that your medical device “offers required performance without compromising patient health and safety” and the “foreseen risks regarding the intended use of the device are mitigated properly”. Clinical data provides this evidence and ensures information for clinical safety and performance of a medical device.
Clinical data sources:
• Clinical investigation for the device under evaluation, or
• Clinical investigation of similar/equivalent devices
AdviQual and DeSia Clinical Research offer best solutions for the collection of clinical data of your medical device.
Clinical Evaluation Report, which is an ongoing process of a lifecycle of the medical device, is a critical part to present a strong evidence.
Clinical Evaluation Report is usually prepared in accordance with MEDDEV 2.7.1 Rev.4 “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC”, which requires assessment of present clinical data of the medical device, an equivalent/similar device assessment and a systematic literature screening.
Clinical Evaluation Report, that was prepared before clinical investigations, includes critical points for clinical investigations to be designed for your medical device.
As AdviQual we can ease your workload by supporting you with our experienced team in
- Determining Essential Requirements required to be supported with a Clinical Evaluation,
- Reviewing available published literature and selecting the appropriate ones,
- Conducting a systematic review to prepare Clinical Evaluation Report in line with MEDDEV 2.7.1 Rev.4,
- Reflecting the findings of the Clinical Evaluation to the risk analysis and product literature (labeling and Instructions for Use) documents.
Post-Market Surveillance (PMS) is the cumulative and systematic data sum of post-market safety and performance of a medical device based on real-world evidence. PMS activities are conducted in accordance with pre-defined and documented procedures and include the actions to be taken in case of any non-conformities regarding the device safety and performance deduced.
PMS activities are conducted in accordance with a “Post-market Surveillance Plan” which was formed for a specific device or device family. Post-Market Surveillance data collected in line with this plan are then processed, analyzed and documented in “Post-Market Surveillance Report”.
Post-Market Surveillance can be proactive by means of activities such as customer surveys or post-market surveillance studies; or can be retrospective through activities including customer complaints, technical service reports or literature search.
Post-Market Surveillance data are also fed into the Clinical Evaluation Report and, as a result, may require revision of risk analysis and instructions for use (or product literature) of the device in question.
We, AdviQual, are ready to serve you when you need our support for preparing Post-Market Surveillance plan and report.
Post Market Clinical Follow-Up (PMCF), is an ongoing process of the clinical evaluation of a medical device, to prove the sustainability of clinical performance and safety of the device in the post-marketing phase.
Post-Market Clinical Follow-Up study is a proactive post-market surveillance activity.
PMCF has been regulated in accordance with “MDD 93/42/EEC as amended by 2007/47/EC” and “Guidance document Medical devices - Market surveillance - Post Market Clinical Follow-up Studies (MEDDEV 2.12/2 Rev.2)”. Now, PMCF has even more critical position since the Medical Device Regulation 2017/745, published officially in May 2017, firming more clear and tighter rules for PMCF requirements.
PMCF studies are conducted in accordance with a pre-prepared plan, similar to device-specific clinical investigations. However, PMCF studies differ from device-specific clinical investigations on follow-up duration, population size, and design characteristics since they usually conducted:
- To focus on the residual risks of the device in question when used as intended,
- To assess specific patient populations
To reinforce clinical evaluation where conformity assessment based on equivalence
PMCF plan and report are device-specific documents.
We and our sister company DeSia Clinical Research are offering the best solution for Medical Device manufacturers for preparation of PMCF plans and management of whole PMCF processes which will be duly demanded by Notified Bodies in line with Medical Device Regulation 2017/745.
Clinical investigation is a systematic study that designed to confirm safety and performance claims of a medical device when used as intended. Clinical investigations of medical devices, similar to the clinical investigation of pharmaceuticals, are conducted in line with a pre-prepared and pre-approved “Clinical Investigation Plan”.
Generally, clinical investigations of medical devices are performed at the pre-CE-mark stage. However, it is now mandatory with the Medical Device Regulation 2017/745, which was officially published in May 2017, to perform a device-specific clinical investigation for implantable and Class III medical devices.
For all matters of clinical investigations, we and our sister company DeSia Clinical Research are working with local and global business partners to offer the best solution for different needs of the medical device manufacturers.