Who this guide is for
- Medical device manufacturers who want to track evolving industry regulations to stay compliant and build a successful regulatory strategy.
- Clinical data professionals who work on medical device studies and need to understand how to collect EU MDR-compliant data.
- Regulatory affairs professionals who seek to improve their skills in the regulatory environment.
- Individuals who want to update their knowledge on European (EU) regulatory affairs and clinical trial data collection.
What you’ll learn
- What PMS and PMCF are, how they relate to each other, and the EU MDR
- Challenges and benefits of PMCF for medical device companies
- How to create a PMCF plan
- How to collect EU MDR-compliant PMCF data
- ISO 14155 and GCP requirements related to PMCF
- How to choose a PMCF solution
- Using ePRO and physician surveys to satisfy the EU MDR and PMCF
The European Medical Devices Regulation (EU MDR) is a new set of regulations that govern medical devices’ production and distribution in Europe, effective May 26, 2021. The EU MDR requires more stringent clinical evidence for medical device manufacturers than previous guidance (Directive 90/385/EEC, Directive 93/42/EEC). As a result, many medical device manufacturers will need to collect more evidence via clinical investigations or other post-market clinical follow-up (PMCF) activities to obtain and renew their Conformitè Europëenne (CE) Mark certifications.
The EU MDR also introduces new classification rules for software as a medical device (SaMD) and emphasizes a lifecycle approach to safety, backed up by clinical data. An integral component of this approach is PMCF, which collects structured post-market data on devices.
Read on to learn the full impact of PMCF under the EU MDR and how to best prepare your medical device studies.
What is post-market surveillance (PMS)?
Post-market surveillance (PMS) is a process that producers and manufacturers employ to take corrective and preventive action (CAPA) on a medical device. PMS actively and systematically gathers, records, and analyzes relevant data on quality, performance, and safety throughout the device’s entire lifecycle.
The data collected under PMS allows manufacturers to monitor a device’s real-world risk continuously and implement necessary changes in real-time. Manufacturers may incorporate a PMS system in the ongoing risk management and clinical evaluation processes throughout the device life span. The method by which a manufacturer conducts PMS depends on the device classification and type.
To conduct PMS, a manufacturer develops a plan that defines the following criteria:
- What data they must collect
- How to analyze the data
- Which actions to take on the data
The plan must also specify the PMCF’s methods and procedures.
Consult this whitepaper for details on the role of PMS during your device’s lifecycle, the specific PMS requirements under the EU MDR, and how an electronic data capture (EDC) system can help you cost-effectively comply with these requirements.
What is a post-market clinical follow-up (PMCF)?
PMCF refers to activities that help provide data, documentation, and evidence regarding a medical device’s safety or performance. PMCF is one component of post-market surveillance (PMS) activities for medical devices. The purpose of PMCF is to confirm the clinical performance and safety of the device in real-world use and help manufacturers manage acceptable risk. PMCF and PMS data safety and performance data collected from real world device usage, is expected to feed back into re-evaluation of Risk determination over the life cycle of the device.
PMCF activities occur after the product receives its CE Mark and supplement the existing pre-market clinical and non-clinical data. Manufacturers must implement PMCF with statistical rationales in patient numbers, device usage, follow-up period, outcomes, and criteria.
Regulatory guidance does not prescribe a specific format for a PMCF study. Numerous options are acceptable, including formal clinical studies, systematically curated evidence available in literature and surveys to generate feedback from medical experts and patients. It is not surprising that manufacturers might find regulatory guidance confusing. Partnering with the right PMCF solution can help.
How does the new EU MDR impact PMCF?
The new EU MDR goes into effect on May 26, 2021: at this date, the recent PMS, vigilance, and market surveillance requirements will apply, and manufacturers must submit device certification applications. New requirements include increased clinical data requirements for manufacturers, which entail more rigorous planning for companies intending to certify or gain re-certification under the new regulation. In summary:
- Regulators require PMCF with PMS and clinical evaluation reporting (CER) obligations and risk assessments and reassessments.
- The EU MDR includes PMCF studies previously addressed under MEDDEV 2.12-2 guidance and reinforces the need to conduct PMCF.
- Manufacturers should develop PMCF plans, including all PMCF activities for the expected lifecycle of their devices. Article XIV Part B section 6.2 of the EU MDR details the specific components manufacturers should include in their PMCF plan.
Challenges and benefits of PMCF for medical device companies
We’ve discussed how the increased clinical data requirements caused by PMCF under the EU MDR will likely be more challenging for most medical device manufacturers. The goal of PMCF is to help manufacturers establish the continued safety of their devices and high-quality data—such as data captured via EDC and electronic Patient-Reported Outcomes (ePRO)—and provide insight into the device’s safety and performance post-market. Data collected using PMCF helps identify device usage problems and clinical outcomes.
While the EU MDR has substantially increased data requirements, PMCF can bring significant value to medical device companies. This blog discusses three critical benefits of PMCF that your company can leverage:
- Helps you stay ahead of the competition
- Provides data that can help your business case
- Facilitates customer connection
How to create a PMCF plan
Medical device manufacturers must outline their PMCF process in a plan and document their PMCF findings in an evaluation report. The PMCF evaluation report is part of both the CER and the device’s technical documentation.
It is essential to select appropriate endpoints for the plan to ensure that you appropriately measure the device’s safety and effectiveness. The overarching goal of PMCF is to demonstrate a favorable benefit-to-risk profile of the medical device throughout its expected lifetime.
- The PMCF plan defines the source of data and data collection method and should be proportional to the device risk.
- The plan may include these components:
- Complaints handling
- Return products analyses
- Vigilance reports
- Literature review
- Registry review
- PMCF studies
- PMCF methods and procedures
- Regulatory feedback
Check out the Castor step-by-step tutorial on creating a PMCF plan.
When is PMCF required?
The EU MDR requires every medical device manufacturer to examine the criteria laid out in the European Commission regulation that governs PMCF MDDEV 2.12/2 and determine whether their device requires a PMCF study. While regulators do not require a PMCF study for every device, manufacturers who believe their device does not need one must include their rationale in their technical documentation.
In summary, risk and novelty are the primary criteria that drive the need for PMCF study. If your device is in a high-risk category and is novel, it will likely require PMCF study. Manufacturers might not find the guidance clear as to whether or not their device needs a PMCF study based on the guidelines and must make a judgement call on whether or not to perform a PMCF study.
To avoid losing existing CE certification from the transition to EU MDR, manufacturers must be proactive: specifically, review the regulation, evaluate the clinical evidence, and develop a gap assessment for their current devices. If clinical data gaps exist, a manufacturer may need to perform a PMCF study as part of their EU MDR transition.
Collecting EU MDR-compliant PMCF data
Collecting high-quality data is the goal for any clinical study, and PMCF studies are no exception. The key is to rely on excellent guidance and sound technology. Since PMCF can include data from various sources, manufacturers should include exact steps for data capture that comply with EU MDR requirements.
Castor has extensive experience guiding European medical device manufacturers through high-quality data capture to comply with EU MDR and other regulations. To learn more about the high-quality data capture during PMCF, download our white paper “PMCF in 5 Steps.”
Understanding ISO 14155 and GCP requirements
Manufacturers should comply with Good Clinical Practice (GCP) for clinical investigations and PMCF studies. In Europe, the International Organization for Standardization (ISO 14155) sets the rules for conducting clinical investigations. Depending on a device’s risk class, market approval status, and study design, manufacturers may need to notify European Competent Authorities before the clinical study starts.
Learn more about “The Impact of ISO 14155 on PMCF Investigations Under the MDR” by downloading our white paper.
Choosing a PMCF solution
With the EU MDR date approaching, it is critical to correctly align your PMCF data collection and compliance for the transition. Castor has extensive experience helping companies with PMCF and offers an end-to-end PMCF solution, where we:
- Help you determine if they require a PMCF study.
- Guide you through the entire PMCF process with time saving and cost-effective strategies.
- Help you develop and implement checklists, tools, and templates for data collection, and directly support and facilitate the actual PMCF studies.
- Provide subject matter experts who partner with you to determine the objectives, endpoints, trial model, sample size, and monitoring plan to ensure PMCF success.
Using ePRO and physician surveys to satisfy the EU MDR and PMCF
PMCF data could include both patient and physician surveys. Using ePRO software for clinical trials provides a survey method to collect this data. Even though this tool’s name implies patient-reported outcomes, manufacturers can use the tool for more broad data collection. Combined with an integrated EDC for seamless data capture and ingestion, ePRO can be a powerful tool for PMCF studies.
Consider these ePRO survey use cases for PMCF:
- A participant answers an ePRO survey/questionnaire before using the medical device. This survey response becomes the patient’s baseline data.
- A healthcare professional responds to an ePRO survey and provides relevant clinical and device information.
Devices intended for patient use, such as insulin pumps or wearable devices, may be best suited for ePRO forms. Using ePRO, you can increase the quality of data available for regulatory affairs, enhance the customer experience with your device, and improve the device’s market performance.
Learn how to quickly set up ePRO to send patient and physician/HCP surveys and leverage another way to satisfy your PMCF requirements.
For medical device manufacturers, the new EU MDR will require more planning, but it also presents an opportunity to improve processes and increase device lifecycles. With the right tools and resources, and the guidance of an expert partner, you can fulfill PMCF requirements and achieve market success. Find out how Castor can help you on your path to compliance. Schedule a demo today.