The European Union Medical Device Regulation (EU MDR, 2017/745) established an appropriate structure that ensures the device’s safety and efficiency. Some of many other guidelines, clinical evaluation and post-market surveillance are regarded as among the most important.
The safety of medical devices must be proven throughout their lifetime and during the manufacturing process. Clinical Evaluation Report and Post-Market Clinical Follow-up are two vital components of this ongoing surveillance.
For monitoring and ensuring the long-term security and function of medical devices, these two technologies are important. PMCF is the procedure for collecting and analyzing clinical data to ensure that a device continues to function as intended after it is placed on the market.
CERs are complete papers that evaluate the clinical and associated data related to the device’s security and efficacy.
In order to ensure that medical devices not only satisfy EU MDR criteria but also adhere to the suggestions and expectations within the MDCG and EC, this blog post examines the relationship between PMCF and CERs.
When put together, they ensure that medical supplies fulfill the necessary safety and performance standards for the duration of their operation.
Understanding Clinical Evaluation Reports (CER)
A communicated review of the clinical data proving a medical device’s validity, safety, and efficacy is known as a clinical evaluation report. Demonstrating that a device satisfies the EU MDR’s standards and will be both safe and highly efficient for usage is the primary objective of the CER.
The clinical evaluation report analyses the existing clinical evidence pertaining to the literature review, pre-marketing clinical studies, and other clinical data types that are being considered.
Clinical evaluation is an ongoing process under the EU MDR. It is a continuous responsibility rather than a one-time task for manufacturers. Whenever new clinical data is available, manufacturers must update the CER to reflect the most recent findings, especially once a device has been put on the market.
Understanding Post-Market Clinical Follow-up (PMCF)
PMCF, in technical terminology, means process for monitoring and evaluation a firm conducts after releasing the product for sale into medical devices post their launch.
Through PMCF, it tries to find at the post-marketed stage with experience in its clinical use, what safety and performance such device, as applied to real-world condition or wherever during premarketing it would have got no experience may demonstrate.
Activities under PMCF include clinical studies, registry data, and other post-market evaluations of how the device performs in different patient populations and different clinical settings.
PMCF not only identifies any potential safety-related problems but will look at whether a device over a period works for long-term benefits, though it has certain complications arising later. Therefore, the input taken through PMCF is essential for upgrading the CER, hence, clinical evaluation is established using the current, most appropriate and reliable input available.
PMCF and CER Alignment under the EU MDR
Under the EU Medical Device Regulation (MDR) 2017/745, continuous clinical evaluation is a cornerstone of device lifecycle management. Manufacturers periodically review and update their Clinical Evaluation Reports, integrating both pre-market data and post-market clinical data, with Post-Market Clinical Follow-up being a vital source of this post-market data.
This integration ensures that the clinical evaluation remains dynamic and reflective of real-world performance, ensuring the ongoing safety and effectiveness of the device.
Several key provisions of the MDR highlight the importance of aligning PMCF with CERs:
Article 61: This article outlines that clinical evaluation must be based on both pre-market and post-market clinical data, emphasizing that PMCF data plays a crucial role in the post-market assessment of the device’s safety and performance.
Annex XIV (Part A): The MDR stresses that clinical data should span the entire lifecycle of the device, with post-market evidence providing continuous value. It underscores the importance of integrating PMCF data into the CER to ensure it reflects the device’s real-world performance and remains comprehensive.
The European Commission’s guideline documents, including MDCG 2020–7 and MEDDEV 2.7/1 Rev. 4, further promote the alignment between PMCF and CER. These suggestions make clear that according to EU MDR how manufacturers must handle clinical evaluation.
MEDDEV 2.7/1 Rev. 4 stipulates that clinical evaluation ought to constitute an ongoing procedure rather than a one-time event. It underlines how crucial it is to regularly include pre-market and post-market data in the CER, particularly the data gathered from PMCF activities. This ensures that the CER is up to date and correctly represents the greatest clinical evidence currently available.
Additional information on PMCF’s function in post-market surveillance may be found in MDCG Guidance on PMCF (MDCG 2020–7). It indicates a manufacturer’s entire approach to assessing the device’s performance ought to include PMCF as an essential element.
The MDCG guidance highlights the quick integration of PMCF results into the CER in order to ensure compliance with the EU MDR and to keep the report updated with the most recent clinical data.
Manufacturers can ensure that their clinical evaluations are in line with the most recent research by consistently adding PMCF data into the CER. This will encourage patient safety and regulatory compliance during every phase of the device’s lifecycle.
The Synergy Between PMCF and CER in Strengthening Clinical Evaluation
Post-market clinical Follow-up data must be included into the Clinical Evaluation Report in order to continuously verify improve the safety and performance of medical devices. This synergy ensures that the clinical evaluation process remains dynamic by combining real-world information with real-time updates.
This method is crucial for preserving the device’s effectiveness in real-world clinical settings since it not only enhances regulatory compliance and guarantees ongoing patient safety, but it additionally promotes the CER’s accuracy by detecting novel risks and adding post-market data.
1. Continuous Clinical Evaluation and Real-Time Updates: CERs have to be updated on an ongoing basis with latest clinical data as they are continuous. Manufacturers can add novel information to the CER via the PMCF’s real-world performance data from clinical settings. This ensures that since the clinical evaluation develops in conjunction with the device’s performance, it will remain relevant over time.
2. Real-World Evidence and Identification of Emerging Risks: PMCF provides real-world clinical data that shows how a device works across a range of patient demography and clinical environments. Risks, adverse results, or performance problems that were not noted in pre-market study may be exposed by this data. By including this input into the CER, the report is ensured to convey the most recent clinical reality and draw notice to any new safety or performance issues.
3. Building Clinical Evidence and Reinforcing the CER: PMCF data may improve the CER’s body of evidence, particularly if it confirms or expands on pre-market trial results. The CER is strengthened by long-term safety and performance data from PMCF, offering insightful information about the device’s performance over time. The CER’s continuous update ensures that it remains to be a true reflection of the device’s clinical performance.
4. Practical Applications of PMCF-CER Alignment: For manufacturers, the alignment of PMCF findings with the CER has significant implications. In addition to ensuring regulatory compliance, it encourages informed decisions and ongoing product development. Manufacturers can ensure the performance, safety, and continual improvement of their medical devices by smoothly merging PMCF data into the CER, in compliance with patient safety standards and regulatory standards.
Conclusion
In conclusion, the alignment of PMCF with CERs is crucial in ensuring that the medical devices are safe, effective, and in compliance with the EU MDR throughout their lifecycle. PMCF provides very valuable real-world evidence that complements and strengthens the clinical data within the CER, allowing manufacturers to continuously monitor and validate the performance of their devices.
The CER’s integration of PMCF data will ensure that the generated devices fulfil the most rigorous safety and effectiveness criteria, conform to legal requirements, and eventually enhance patient outcomes. In addition to aiding in regulatory compliance, the relationship between PMCF and CER supports the sustainability and safety of medical devices on the market.
Author Name: Athira Unnikrishnan
Author designation: Junior Consultant (CER)
REFERENCES
1. European Union MDR: EU. (2017). Medical device regulation (EU) 2017/745. The European Union’s official journal
2. Commission for Europe (2015). Clinical Evaluation: A Guide for Manufacturers and Notified Bodies, MEDDEV 2.7/1 Rev. 4.
3. MDCG, the Medical Device Coordination Group (2020). MDCG 2020–7: Clinical Evaluation-Equivalence: A Guide for Notified Bodies and Manufacturers. European Commission.