Post-market surveillance (PMS) is a significant portion of the regulatory obligations for medical devices in Europe. The Medical Device Regulation (MDR) places superior stress on collecting clinical and safety- data after the consent/CE certification process and market admittance.
Analyzing product performance of CE approved products is vital to methodically recognizing risks in the real-world application of the product, as some risks only become visible when medical devices are utilized, warehoused, shifted or subjected to a cleaning activity. Therefore, merely through constant and methodical post-market surveillance can manufacturers confirm that medical devices are harmless and that there are no uncontrolled risks for example defects or unnoticed security complications. PMCF is an important part of the PMS.
Post-Market Clinical Follow-up (PMCF)
The PMCF is the systematic process for collecting clinical data with the objective of responding significant queries related to the medical device safety or performance and modifying its clinical evaluation as per the needs.
Post-market surveillance data and analysis has to be incorporated in the post-market part of the Clinical Evaluation Report (CER). The process to regularly posting the clinical evaluation with the post-market collected data is known as Post-Market Clinical Follow-up (PMCF) and described in Annex XIV Part 2. The MDR helps manufacturers to robustly collect and assess clinical data from the end operators of the medical devices to verify the device safety and performance throughout its anticipated lifetime. This aids them ascertain the suitability of already recognized risks and to notice developing risks on the foundation of truthful indications.
Producers have to develop their PMCF process on a comprehensive plan; the outcomes of the PMCF have to be recorded in a PMCF evaluation report, which is one important area of the clinical evaluation report and the related technical documentation. The deductions of the PMCF may also result in updating documents related to risk management.
Post-market statistics has to be utilized to regularly to reevaluate the risk-benefit analysis in the CER and to modify the risk management portion of the technical documents. Any regulatory measure (for example recalls and notifications) has to be explained, incidents should be exhibited in a table and (high risk) adverse events stated in depth (with an emphasis on the assessment of whether an incident is device-oriented or not).
Data Types to be gathered to comply PMCF requirements
PMCF can comprise of data collected from the complaints, vigilance system, technical information and publicly accessible info, and does not specify only to PMCF studies. The MDR references the collection of clinical experience and understanding learned, comments and recommendations from users, evaluation of scientific literature as universal approaches and procedures of accumulating pertinent data. It manages the assessment of appropriate registers or studies related PMCF studies as definite methods. The PMCF plan necessitates a justification for the suitability and correctness of the procedures and methodology; a manufacturer selects to implement.
PMCF Study Under the Presently Enforced MDD
Some of the applicable MDR articles and the gist of their texts are:
• Article 75 MDR explains considerable changes to clinical investigations. It is probable to modify an continuing investigation, but be careful that the authorities are included, if the modifications are prospective to meaningfully influence safety, health, or other rights of the subjects.
• Article 76 MDR explains actions adopted by Member States concerning clinical investigation does not applicable yet, but article 15.6 of the prevalent MDD does the identical function: if an investigation is instigating worry about public health, the regulatory bodies and concerned authorities may need to hinder.
• Article 77 MDR explains details that needs to be furnished at the completion of an investigation (or early termination) does not yet put on. But, if a study or investigation is intimated to the authorities, they should be updated about the changes. The Notified Body should also be made aware of the changes..
• Finally, occurrences where a patient or end-user was wounded or potentially have been injured due to a failure or defect of the medical device or its consumer details should be reported to the pertinent authorities just as in any other vigilance case.
Professionals have seen occurrences in numerous countries where the Competent Authority modify the investigation from a PMCF to a usual clinical study. These clinical studies were liable to Competent Authority’s endorsement because the therapeutic, diagnostic, or patient monitoring schedule(s) changed from the IFU or from recognized medical practice. It is significantly imperative to assess the likelihood for this consequence for every proposed study, as the expenses and time variables are significantly affected.
Steps for PMCF Compliance under new MDR
In Europe, PMCF and PMCF studies are not new ideas for medical device compliance. But, the MDR’s meaning of PMCF left few producers pondering how to fulfill or continue compliance under the new regulation. Remember these important points to get ready for Notified Body requirements for PMCF under the new MDR:
1. Initiate PMCF studies now, regardless if your devices are already still CE Marked under the MDD so as to be ready for compliance under the new MDR.
2. Prepare a gap analysis on clinical data regarding the new MDR.
3. Develop studies with the new MDR requirements in perspective, to empower appropriateness of these data for authorization under the MDR.
4. Confirm whether the study could cause a status modification to “pre-CE-marking” or usual, which is dependent on Competent Authority approval. Confirm the restructured, revised Clinical Master Plan with your Notified Body to safeguard future acknowledgement and deal with unwanted surprises.
TS Q & E can offer suitable consultancy on the changes which should be tailored in your PMCF studies and data for your devices. Please contact us through our inquiry form.