The concept of post-market clinical follow-up (PMCF) has been a part of the EU medical device legislation since the introduction of the Active Implantable Medical Device Directive (AIMDD) 90/385/EEC and the Medical Device Directive 93/42/EEC. However, the introduction of the Medical Device Regulation (MDR) (EU) 2017/745 has brought a new emphasis to PMCF, explicitly setting several requirements that manufacturers must meet to achieve and maintain CE certification.
This article provides practical, informative guidance to assist manufacturers in integrating the requirements for PMCF into their quality management system and technical documentation, ensuring that they meet the requirements of the MDR, now and in the future.
Table of Contents
- What is PMCF?
- Device Lifetime/Lifecycle
- Importance of PMCF
- Integrating PMS/PMCF into Your QMS
- Writing a PMCF Plan
- Sources of PMCF Data
- Documentation Maintenance Challenges
- PMCF Reporting
What is Post-Market Clinical Follow-Up?
PMCF (MDR Annex XIV, PART B, 5) is a continuous process that updates the clinical evaluation (Article 61, Annex XIV, Part A). The manufacturer must proactively collect and evaluate clinical data from the use of their CE-marked device in or on humans with the aim of confirming the safety and performance throughout the device’s lifetime.
Clinical data (MDR Article 2(48)) is defined as information concerning safety or performance that is generated from the use of a device and is sourced from the following:
- Clinical investigations or studies on the device concerned
- Clinical investigations or studies reported in the scientific literature of equivalent devices
- Reports published in the peer-reviewed scientific literature on other clinical experiences of the device in question or the equivalent device
- Clinically relevant information coming from post-market surveillance, in particular, post-market clinical follow-up
The requirements often seem daunting because they appear to require manufacturers to run post-market clinical investigations, which are costly, time-consuming, and, in some cases, unnecessary. In reality, the type and scope of post-market activities will be based on the risk profile of the device. A high-risk, novel, Class III implantable device may require a PMCF study for the device’s lifetime spanning several years. However, a Class I device may need a simple survey to collect user feedback, which, to some degree, must include some clinical data, e.g., questions concerning the intended purpose and indications for use.
Fundamentally, post-market surveillance (PMS), which includes PMCF, is the system used to collect real-world data (RWD), providing real-world evidence (RWE) that supports the manufacturers, performance, safety, and clinical benefit claims for their device.
Figure 1 provides an overview of the clinical evaluation process. PMCF is an integral part of the post-market feedback process and comprises the PMCF plan and PMCF report.
Figure 1: Clinical Evaluation as Part of the Risk Management Process
The diagram above shows the relationship between lifetime and lifecycle with respect to post-market surveillance. The PMS lifecycle can start before market release, as PMS data from existing equivalent or similar devices can be used to inform the design of new devices.
PMS/PMCF and the Device Lifetime/Lifecycle
The MDR often refers to device lifetime with respect to the duration of processes, such as PMS (Article 83) and PMCF. There are two aspects to this. Firstly, the manufacturer is expected to collect PMS data, including that collected through PMCF, which supports the manufacturer’s claims for the operational lifetime of the device. Collecting operational lifetime data is essential for those devices, such as implants, that may have been approved without the whole lifetime being validated with clinical data from its use in humans. Secondly, there is the expectation that PMS will continue until the device is removed from the market, i.e., PMS shall continue until the lifecycle of the device is complete and it is no longer marketed.
Figure 2: Lifetime and Lifecycle of a Medical Device
The Importance of PMCF
Post-market surveillance, as well as being a regulatory requirement, provides the manufacturer with the assurance that their devices continue to work as expected. Unfortunately, historically, once a device has been released to the market, manufacturers tend to be less proactive in collecting and analyzing post-market clinical data. Therefore, the MDR has addressed this issue by requiring manufacturers to write a PMCF plan, which is an integral part of their post-market surveillance system. The Notified Body will review the PMCF plan as part of the CE-certification process and view it as a binding commitment by the manufacturer. The Notified Body will review progress against the plan during periodic surveillance audits and certificate renewals. Failure to carry out the agreed plan may result in CE certification suspension or cancellation.
For legacy devices (those previously certified under the MDD or AIMDD), the manufacturer may be required to collect PMCF data before MDR CE certification is granted because, as per MDR Article 120(3d), manufacturers, from 26 May 2021, should have adopted the PMS, including the PMCF requirements of the regulation. Notified Bodies can raise major non-conformances against manufacturers who have failed to meet their PMCF obligations.
For devices that gained certification through equivalence, PMCF is essential to ensure that clinical data is collected for the actual device. Again, Notified Bodies may raise major non-conformances against manufacturers who have failed to collect PMCF data on their devices.
For new or novel devices, the Notified Body may restrict the use of the device by limiting the scope of the CE certificate to PMCF studies only, therefore ensuring a controlled rollout of the device and limiting any potential patient risk. Once the manufacturer has collected sufficient PMCF clinical data, they can obtain approval for unrestricted use of their device in the intended patient population.
What is the Purpose of PMCF?
As stated in MDR Annex XIV, Part B, 6.1(a-e), the objective of collecting post-market clinical data is to:
- Confirm the safety and performance of the device throughout its expected lifetime
- Identify previously unknown side effects and monitor the identified side effects and contraindications
- Identify and analyze emergent risks on the basis of factual evidence
- Ensure the continued acceptability of the benefit-risk ratio
- Identify possible systematic misuse or off-label use of the device, with the view to verifying that the intended purpose is correct.
Integrating PMS/PMCF Into Your Quality Management System (QMS)
Post-market surveillance, including PMCF, must be integrated into the manufacturer’s quality management system (QMS) as a set of processes, procedures, and work instructions, as applicable.
MDR Article 10 details the general obligation of the manufacturer, including QMS requirements. Article 10, 9(i) sets out the general requirements for setting up, implementing, and maintaining a PMS system in accordance with Article 83.
Article 83 defines the requirements for the manufacturer’s post-market surveillance system.
Article 84 defines the requirements for the post-market surveillance plan, referencing Annex III.
Annex III outlines the requirements for the post-market surveillance plan, including 1.1(b), 10th indent requiring the PMS plan to cover the PMCF plan as referred to in Part B of Annex XIV, or a justification why it is not applicable.
Annex XIV, Part B defines the requirements for post-market clinical follow-up.
EN ISO 13485:2016/A11:2021 is harmonized with the MDR and provides a presumption of conformity with the applicable MDR QMS requirements. Within EN ISO 13485, Annexes ZA, 1-3 offer helpful references to determine if the application of the standards covers the relevant QMS requirements of the MDR. Although harmonized, EN ISO 13485 does not provide the presumption of conformity with all the QMS requirements of the MDR. Therefore, some MDR requirements will need to be written into the quality management system in their own right, including PMS and PMCF requirements.
A traceability matrix, based on EN ISO 13485 Annex ZA, should be developed to detail how the relevant QMS clauses of the regulation have been met. The traceability matrix can be used to support the internal audit process, which should include the clauses of EN ISO 13485 and the relevant provisions of the MDR.
PMCF Consulting Services
Writing a PMCF Plan
Typically, the PMS and PMCF plans will be written as separate documents because the PMS plan is broadly based on the application of established QMS procedures and work instructions. In contrast, the PMCF plan details device or device-family-specific activities.
The PMS plan is based on established procedures for post-market surveillance, clinical studies, risk management, complaints handling, trending, incident determination/reporting, corrective and preventative action, device traceability, change control, technical file construction/maintenance, post-market surveillance reporting, and periodic safety update reporting (PSUR).
The PMCF plan and its subsequent report should be written using the following Medical Device Coordination Group (MDCG) templates:
- MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template, A guide for manufacturers and notified bodies
- MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template, A guide for manufacturers and notified bodies
MDCG 2020-7 provides a standard template for presenting the PMCF plan to the Notified Body. The PMCF Plan consists of the following sections:
- Section A – Manufacturer contact details. Ensure that all information is presented as required. Per the guidance, the person responsible for regulatory compliance (PRRC) should be named. The PRRC is responsible for ensuring that the PMCF plan is executed as described.
- Section B – Medical device description and specifications. Use pictures and tables to describe models and variants. Ensure that descriptions are complete and aligned with other key documents, such as the instructions for use (IFU), clinical evaluation plan (CEP), and clinical evaluation report (CER). The lifetime claim should be backed up by verification and validation testing and considered when determining the duration of the PMCF plan, i.e., as per MDR Annex XIV, Part B, 6.1(a), the PMCF plan should be designed to collect clinical data with the aim of confirming the safety and performance of the device throughout its expected lifetime.
- Section C – Activities related to PMCF: general and specific methods and procedures. Per MDR Annex XIV, Part B, 6.2(a), general methods of PMCF include but are not limited to, literature searches, user satisfaction surveys, and other sources of clinical experience gained. It is advisable not to repeat any general PMS activities that are covered by the PMS plan in the PMCF plan, such as complaints and vigilance, to limit errors and inconsistencies and facilitate document maintenance. The PMS plan and PMCF plan should be complimentary but effectively standalone.
Per MDR Annex XIV, Part B 6.2(b), specific methods of PMCF are registries or studies. Studies can include high-quality case-based surveys.
General and specific methods of PMCF are discussed in more detail later.
- Section D – Reference to the relevant parts of the technical documentation. The purpose of this section is to identify any parts of the clinical evaluation and risk management that need to be analyzed, followed up on, and evaluated as part of the PMCF activities. For example, the clinical evaluation may have identified gaps in the data for specific populations, such as pediatrics, that need to be addressed by the PMCF plan, or it could be that the risk management needs to be updated with long-term undesirable side effects.
There is a tendency for manufacturers to emphasize favorable clinical data and to play down the unfavorable when presenting their clinical evaluation to reduce the PMCF burden. This strategy works sometimes, but Notified Bodies are trained to identify these gaps and will expect these to be addressed, and this can lead to delaying certification. Within the spirit of the MDR, clinical evaluations should be an honest and balanced assessment of all available clinical/safety data.
- Section E – Evaluation of clinical data relating to equivalent or similar devices. Literature searches are a general method of PMCF and should encompass the actual device, equivalent devices (if applicable), and similar devices. This section is used to identify equivalent and similar devices so that they can be considered in the literature searches. Data on equivalent and similar devices is used to update the state-of-the-art analysis and identify emerging safety issues.
- Section F – Reference to any applicable common specification(s), harmonized standard(s), or applicable guidance document(s). List the common specifications, standards, and guidance that have been applied and ensure continued compliance with the latest versions as part of the PMCF activities. Maintain a master list of the common specifications, standards, and guidance to ensure consistency across all technical documentation.
- Section G – Estimated date of the PMCF evaluation report. State the date by which the PMCF report will be published. When determining the PMS/PMCF schedules, consideration should be given to the interdependencies between the documents, e.g., the PMCF report will feed CER and PSUR updates, etc.
Sources of PMCF Data
General methods of PMCF
Per MDR Annex XIV, Part B, 6.2(a), general methods of PMCF include gathering clinical experience gained, receiving feedback from users, screening scientific literature, and other sources of clinical data. The MDR does not indicate how these activities are to be carried out, and MDCG guidance is limited. Therefore, the following sections provide some practical advice.
1. Gathering of clinical experience gained
The gathering of clinical experience gained is a general requirement that applies to all methods of data collection listed in the PMS and PMCF plans.
2. Feedback from users
Feedback from users can be gathered using surveys. In the context of general methods, this type of survey would focus on customer satisfaction, usability, and general questions about the intended purpose and indications for use. Users will complete the survey once after gaining experience using the device. It is not a case-based survey and does not collect specific patient data such as short or long-term outcomes, etc. Per MDCG 2020-6, Appendix III, data gathered using user satisfaction surveys would be considered Rank 8, Proactive PMS data, such as that derived from surveys. MDCG 2020-6 is aimed at legacy devices, those previously CE marked under the MDD or AIMDD. However, in lieu of any other methods to rank clinical data, it is pragmatic to apply it to new devices under the MDR to support the manufacturer’s sufficiency (see page 8 in this PDF) claims regarding clinical data.
Other methods of general feedback include that gathered from marketing events, technical shows, sales support meetings, etc. The information may be less formal, but it may identify issues that have not been previously reported.
3. Screening of scientific literature
By incorporating the screening of scientific literature, the PMCF plan effectively formalizes the periodic updates of the clinical evaluation as described in MDR Annex XIV, Part A. Although the MDR does not specify how often the clinical evaluation should be updated, for Class IIa, IIb, and III devices, updates will generally align with the frequency of the PSUR because the PSUR provides a summary of the PMCF data, which includes literature searches. Therefore, the frequency of the PMCF plan literature searches and the clinical evaluation updates should be aligned with the PSUR schedule. This assumption is supported by MEDDEV 2.7/1 Rev. 4, Section 6.2.3, (a) Frequency of updates, which recommends the clinical evaluation is updated annually for high-risk devices and every 2 – 5 years if the device is not expected to carry significant risk. For Class I devices, an update frequency of 2 – 5 years might be justified. However, for Class IIa devices, the update frequency will be no greater than 2 years, and for Class IIb and III devices, it will be annually.
When writing the PMCF plan, consider leveraging the CEP and avoid duplication of activities across documents, i.e., the screening and analysis of clinical literature will be performed as per the Clinical Evaluation Plan.
The results of the clinical literature searches are typically analyzed within the CER and not the PMCF report. Unfortunately, the MDR only states what should be done but not how. The critical point is to reduce repetition across the documentation as much as possible and decide which master documents are for analysis and which are for summarizing and reporting results.
Literature searches must include the actual, equivalent, and similar devices, alternate therapies, healthcare guidance, and international vigilance databases.
4. Other sources of clinical data
This requirement is a catch-all, i.e., it allows the manufacturer to include any other sources of clinical data. However, from a practical perspective, the majority of different sources, such as complaints and vigilance data, will be gathered following the PMS plan, and duplication in the PMCF plan should be avoided.
Specific methods of PMCF
Per MDR Annex XIV, Part B, 6.2(b), specific methods of PMCF include registries or PMCF studies.
Specific methods of PMCF will not be required in all cases, particularly if the device is considered well-established technology (WET), a standard of care device, or a legacy device, and the manufacturer can justify the sufficiency of the existing clinical data, including that to support device lifetime claims.
The clinical evaluation should be used to determine the scope and type of the specific methods of PMCF by identifying any gaps in the clinical data and considering performance, safety, and clinical benefits that need to be addressed. The types of gaps may be, but are not limited to the following:
- There is no long-term data for a new permanent implant.
- The device family has many variants, not all of which have pre-CE marking data.
- Limited data for specific high-risk populations, e.g., pediatrics or older people.
- The risks associated with the use of the device are not fully quantified.
- New risks identified from the literature require follow-up.
- Verification of the device is required when exposed to a more extensive and more varied population of users.
MEDDEV 2.12, Rev. 2, Market Surveillance – Post Market Clinical Follow-up Studies, provides some valuable and relevant guidance that remains applicable to the MDR.
All ongoing studies on the device should be included in the PMCF plan, for example, studies that are being run to expand the intended purpose or indication for the use of the device or studies that are continuing to collect long-term data because they will provide new insights into the device’s performance and safety.
In designing post-market clinical investigations, consideration should be given to the requirements of ISO 14155:2020, Annex I. The standard includes a section on post-market clinical investigations and registries. In particular, section I.7 refers to the applicability of the principles of ISO 14155:2020 to these studies, in part or in full, depending on the clinical development stage and type of clinical investigation design, with justifications for exemptions from the standard. Section I.7 provides examples of suitable exemptions, e.g., regulatory authority approval, investigator’s brochures, investigational labeling requirements, etc.
Registries
A registry is a database used to collect case-specific clinical performance and safety data. Each record typically pertains to a single patient/user and their experience with the device.
Registries, such as National Joint Registries, are most commonly employed to collect long-term medical device outcomes. However, they can also be utilized for short-term surveillance in small or niche populations where it could take several years to collect the data.
Registries are ideal for bridging the safety and performance gaps between devices in pre-CE mark clinical trials (where there are strict controls) and their routine use in the real world.
Public healthcare bodies or associations usually mandate registries. However, manufacturers can also choose to establish a registry to meet their PMCF obligations. Healthcare facilities will be enrolled to participate in the registry and enter data after each use of the device.
For practical reasons, including cost, registries are not suitable for all devices, and they are typically used for implantable devices, where long-term safety and performance data over the lifetime of the device, which could be several years or decades, is required.
Clinical investigations or studies
The MDR Article 2(45) defines a clinical investigation as a systematic investigation involving one or more human subjects undertaken to assess the safety and performance of a device.
In the context of PMCF, clinical investigations aim at minima to confirm the safety and performance profile of the device throughout its expected lifetime. In some cases, the CER may result in gaps in the clinical evidence of the device, and additional activities outside the routine assessments may be required to address these gaps.
There are three main types of PMCF studies for CE-marked devices that are being used as intended:
- Studies without any additional activity outside the routine assessments (observational standard of care studies): Observational studies can be prospective (studying and following up on new cases as they occur) or retrospective (reviewing existing medical records). In some EU countries, registries can be used to collect observational study data.
- Studies with additional procedures that are invasive or burdensome: Participants in these studies are subjected to high-risk procedures in addition to those performed under the normal conditions of use of the device.
- Studies with additional procedures that are not burdensome. These activities that are additional but not burdensome may include, for example, a prospective quality of life questionnaire or an extra blood sample of limited mL.
On the matter of additional study procedures, MDCG 2021-6 gives some general indications of what could be considered burdensome. It is, however, the responsibility of the Sponsor to define it from the perspective of the person bearing the burden. For example, the same activity could be considered not burdensome to a younger adult but burdensome to an elderly patient.
For legacy devices, which have been on the market for several years and have a well-known history of safe use, the challenge for manufacturers that have limited resources is determining how to collect the minimum required amount of PMCF data most efficiently. This problem can be compounded if, historically, the manufacturer has failed to collect any PMCF data, particularly for devices where the initial certification was based on equivalency. If performed objectively, the clinical evaluation will identify gaps in the clinical data and provide a guide on what data is needed. The manufacturer can then select the appropriate data collection method and tune it based on the legacy status of the device and its history of safe use.
High-quality surveys
High-quality surveys are case-based and prospective or retrospective or a mix of both, i.e., they collect information on the use of the device on one patient at a time. Typically, they aim to collect quantitative data covering the intended purpose, indications for use, and outcomes.
The manufacturer should develop a survey protocol that, ideally, follows EN ISO 14155, Annex A, to ensure that all aspects of the investigation have been considered.
For legacy devices that have a well-known performance and safety profile but lack sufficient clinical data for CE marking under the MDR, it may be possible to justify a wholly anonymized survey, where data cannot be traced back to individual patients.
When developing the statistical analysis plan for a high-quality survey, the chosen model should be proportionate to the type of study questions that are being answered. For many legacy devices, the study may not need to be powered by any particular endpoint or individual question. Therefore, sample sizes could be based on the expected population using the device, the required confidence level, and the margin of error. An additional approach could be to set a performance goal instead of formal hypothesis testing. For devices with a well-established market history or those considered standard-of-care devices, it may be possible to justify a wider confidence interval and higher error rate to reduce the sample size and number of surveys required. No matter which approach is selected, a detailed justification for the statistical methodologies used should be presented.
When writing the questionnaire, it is crucial to ask relevant questions, understand the purpose behind asking each question, and determine how the answers will be analyzed and presented in the PMCF report. Taking this approach will prevent unnecessary questions from being asked. The number of questions should be limited to ensure that the survey is not overly burdensome for the survey participants, who are typically doctors or nurses with limited time.
To ensure that clinical data is gathered, questions must cover the intended purpose, indication for use, any quality/safety issues, adverse events, and outcomes. However, if the intention is to follow up with patients after the initial procedure, the survey may need to be pseudo-anonymized to allow patient identification at a later stage. In this case, informed consent will likely be required.
One of the challenges with surveys, or any PMCF study, is identifying the scope. In the majority of cases, particularly for devices with a well-known performance and safety profile, where there is sufficient clinical evidence to support the use of the generic device group, it is not necessary to demonstrate long-term clinical benefit. For example, the manufacturer of a blood pressure monitor does not need to continually prove that monitoring blood pressure results in a better outcome for the patient. They need to demonstrate the performance of their blood pressure monitor within the clinical environment. Therefore, the PMCF activity will be more targeted to usability, quality, and safety.
A helpful concept is to consider a device’s technical success vs. its clinical benefit. As indicated above, the clinical benefit of many devices is well-established, so the PMCF should focus on technical success. For example, consider a peripheral arterial balloon catheter for Percutaneous Transluminal Angioplasty (PTA) used to dilate a blocked artery. The use of balloon catheters is well-established. Therefore, it is not necessary to reverify the efficacy of balloon angioplasty but to focus on the ability of the device to dilate the blocked blood vessel without complications, i.e., its technical success. The catheter must be able to be inserted in the artery and maneuvered to the blockage. The balloon must be inflated to enlarge the vessel at the blockage site and improve the blood flow. The balloon must be deflated and the catheter removed.
From a survey perspective, only two questions are necessary: was the blood vessel successfully dilated at the target site, and were there any complications or adverse events related to the catheter? If the response to these questions is yes and no, respectively, technical success is assured, and the intended purpose has been validated. Other questions concerning the patient’s age, sex, and disease state (the answers to which can be completely anonymous) will validate the indications for use. In this example, once used, the balloon catheter has no bearing on the medium to long-term clinical outcome for the patient, i.e., it can only dilate the vessel. It cannot make it stay dilated. A stent may be required for this. Therefore, it can be justified that long-term follow-up is not required. It pays to be pragmatic so as not to over-engineer the PMCF survey, particularly for standard-of-care devices. The concept of technical success may help.
Consideration should be given to how the data is collected. In a high-quality observational survey, it may be necessary for a third party to observe the use of the device and collect the data or for the user (doctor/nurse/patient) to complete the survey. Each comes with the challenges of time and cost.
Any limitations of the survey must be identified, documented, and, where possible, mitigated or justified to support sufficiency claims.
EU Technical Documentation
The Role of National Competent Authorities
Regarding the post-market activities that we have presented in the previous sections, there is no harmonized approach among the member states at the moment.
For PMCF studies with additional burdensome activities, Article 74(1) applies. The National Competent Authority (NCA) should be notified by the Sponsor at least 30 days prior to commencement of the study. In some countries, the NCA will provide feedback. In others, it won’t.
The situation may even be more complex for observational studies. In some countries, these studies fall under Article 82 and consequently are handled by national provisions, while in others, they are studies outside the scope of the regulation. Because observational studies on routine assessments may be considered studies on data and not on human subjects, they do not fall under the definition of clinical investigation of Article 2(46). Studies of data generally can be waived and do not need any regulatory or ethical approval before commencing.
Another case that could be applicable for innovative medical devices that just obtained the CE mark is the consideration of what the standard of care is. If a new innovative device is still not in use in a hospital, it is unlikely that the ethics committee will consider the PMCF study as observational.
Documentation Maintenance Challenges
Within the systems created by the MDR, there is a lot of repetition of the same information across several documents, which can lead to inconsistencies and difficulties with maintenance unless carefully managed. For example, the IFU, CEP, CER, summary of safety and clinical performance (SSCP), and PMCF plans require a detailed device description. Also, the PMCF report, CER, periodic safety update report (PSUR), and SSCP all need to reference the output of the literature searches, etc.
When maintaining the technical documentation, it is crucial to identify the approved master sources of information before dissemination into the other documents, especially if multiple people are involved. For example, maintain an approved standards list, which also includes the common specifications and guidance applicable to the device. The approved master standards list can then be referenced within other documents, assuring consistency. Considering the device descriptions, it may be that the IFU is the master document, and all other documents containing device descriptions are aligned with it.
It is also necessary to determine where the analysis of information is carried out. For example, although a general method of PMCF is literature searches, the assessment of the literature should, ideally, be carried out in the CER and not the PMCF report. However, the data gathered from a survey may be analyzed in the PMCF report and summarized in the CER. A manufacturer’s procedures must allow the flow of information between processes to avoid unnecessary repetition of information or different analyses and conclusions to be drawn on the same dataset.
In many cases, the generation and maintenance of the documentation becomes a cyclic process as data is analyzed, conclusions drawn, and then the information disseminated into the relevant documents. It can be a slow process, particularly during the analysis stage, where the information is in a state of flux.
To ensure consistency, one person should oversee the critical documents for each device or device family, and this may be the PRRC or a delegate.
Notified Bodies are keen to pick up on inconsistencies, which result in questions and delays in the certification process. Furthermore, if incorrect data is supplied to the user or patient, it may result in field safety corrective action. Therefore, it is essential to invest the time and get it right.
PMCF Reporting
The PMCF plan must provide an estimated due date for the PMCF report. The PMCF report should be compiled following the template presented in the guidance document MDCG 2020-8. It should not be forgotten that the results of the PMCF plan should be used to update the clinical evaluation, and potentially, this may require other documents, as described in the previous section, to be updated.
Scheduling of all PMS activities and updates is essential to ensure continued compliance with the MDR.
Reporting Changes to the PMCF Plan
The PMCF plan for Class IIa, IIb, and III devices is a controlled document approved by the Notified Body as part of its CE certification assessment. Therefore, any significant changes to the plan, including the device scope, type of study/survey, methodology, statistical methods, sample size, etc., must be reported to the Notified Body. Failure to report and agree to changes may result in a major non-conformity and, in some cases, lead to CE certificate suspension.
For Class I devices, where there is no Notified Body involvement in assessing PMCF activities, it is not necessary to report changes.
The Duration of PMCF
PMCF is a continuous process that updates the clinical evaluation referred to in MDR Article 61. Because Annex XIV, Part B, 6.1(a) requires the general methods of PMCF to include literature searches, as a minimum, the general methods of PMCF will likely continue for the lifecycle of the device, i.e., until it is removed from the market, and after that if data has not been collected for the lifetime of the device (e.g., an implant that is removed from the market before longterm lifetime data has been collected). However, specific methods of PMCF per Annex XIV, Part B, 6.2(a) can be ended once there is sufficient clinical data to address gaps in the clinical evaluation.
Annex III, 1.1(b), Indent 10, allows for the manufacturer to justify why PMCF is not applicable. However, this is only likely to be appropriate for devices where it can be demonstrated that there is no new or emerging clinical data or developments in the state-of-the-art.
Conclusion
The gathering and analysis of real-world data through the PMCF plan supports the ongoing performance and clinical benefit of the device and is essential in maintaining patient safety.
Manufacturers are encouraged to develop robust systems for PMS and PMCF, where possible, standardizing pre-CE and post-CE clinical data collection methods to ensure devices are brought to market in a timely fashion and certification is adequately maintained.
PMS and PMCF are integral parts of the MDR. Failure to plan and execute PMS and PMCF activities may result in the Notified Body refusing certification at the application stage or suspending already issued certificates.
NAMSA’s clinical and regulatory teams are able to support you with all your MDR documentation needs and have experience in the development and implementation of customer satisfaction surveys, observational studies (including high-quality surveys), registries, and interventional studies.
