Marketing a device in the European market means complying with the numerous safety and technical requirements of the Medical Device Regulation (MDR). In practice, this can be an extremely challenging process, particularly for startups or companies who are new to marketing devices in Europe.
That’s why we’ve created this ultimate guide to break down the device class requirements under the European MDR. Along with instructions on how to classify and categorize your devices, you’ll learn exactly what you need to know for preparing technical documentation, conducting clinical evaluations, running postmarket studies, and ensuring your device is safe and effective.
Without any further preamble, let’s take a look at classifying your device and what it means for your path toward CE marking and legal sale under EU MDR. If you want to skip our summary, you can go straight to downloading our eBook.
There are a number of different routes of assessment to obtain CE marking for your product, and the route you take depends on the risk class of your device under the MDR. In addition to the classification requirements detailed in MDR, the Medical Device Coordination Group (MDCG) published the guidance document MDCG 2021-24 as a simplified resource to help manufacturers determine the class of their medical devices under Regulation (EU) 2017/745.
The MDR designates four medical device classifications:
Each of these risk classes requires a different conformity assessment route, which will determine the steps you’re required to take for CE marking. The EU uses a rule-based system for determining the risk class of a medical device. In Annex VIII of the MDR, you’ll find 22 rules for classifying any medical device.1
The rules are divided into four sections, and the rules of each section apply to a specific category of devices.
Additionally, the duration of the device’s use is used to determine which rule(s) apply within a given category.
The three types of duration specified in the MDR are:
Choose the rule(s) most applicable to your device in order to determine the risk class of your medical device in the EU. If several of the rules apply to your device, the MDR stipulates that you should use the strictest rule that results in the highest level of classification.
Overall, MDR is less focused on the pre-approval stage of medical device manufacturing, and instead, promotes a lifecycle approach to medical device regulation. This can be found in changing safety requirements and technical documentation.
The general requirement under the new MDR is that all currently approved devices must be re-certified to ensure their compliance with the new medical device requirements. Even medical devices that obtained CE markings under the previous directive must demonstrate compliance with the new EU MDR.
Additionally, manufacturers of Class IIa and IIb medical devices will need to review their existing clinical evaluations to determine whether they satisfy the updated regulations. Certain medical devices that were previously exempt from requiring clinical evaluations may now.
In this blog we are going to look at the EU MDR requirements for class I devices. If you want to see an overview of your device class' requirements, click here to get the eBook.
Class I medical devices in the EU have the lowest perceived risk. In many cases, the manufacturer can self-certify Class I devices without the involvement of a notified body. This risk class includes products like stethoscopes, bandages, or glasses.
As seen in the graphic above, Class I devices must fulfill obligations and technical requirements for:
Without further ado, let’s jump into the specifics of each safety and technical requirement for your Class I device under EU MDR.
The clinical evaluation report (CER) is documentation of the clinical evaluation that is required of every medical device sold in the EU. Its purpose is to prove your device performs as intended without compromising the safety of its end users.
Article 61 of EU MDR requires every medical device manufacturer to document the clinical evaluation of their device in a CER.3 This requirement is expanded upon in Annex XIV Part A, which states:
The results of the clinical evaluation and the clinical evidence on which it is based shall be documented in a clinical evaluation report which shall support the assessment of the conformity of the device.
MDCG-2020-5 and MDCG 2020-13 are guidance documents for clinical evaluations, and contain instructions and specific requirements for the clinical evaluation report.5
MDCG-2020-5 states that your CER should contain sufficient information for anyone reading it to understand the search criteria, the included data, and all assumptions made as well as all conclusions reached.
MDCG-2020-13 provides a sample table of contents, which indicate the CER should include:
- Medical device name model and type
- Manufacturer(s) name and SRN
- Notified body
- Type of assessment
- Intended purpose
- Check of clinical evaluation report authors
- Clinical evaluation plan
- Information materials supplied by the manufacturer
- Common specifications and harmonised standards applied
- Demonstration of equivalence
- State of the art
For Class I devices, the CE Report must be updated every 2-5 years. Because Class I devices are low-risk, the guidance allows for you to define your own update schedule based on the device’s intended use, frequency of usage, and overall level of risk. However, if at any point you receive new and pertinent information about your device through post-market surveillance or new clinical evaluations, then the CER must be updated to reflect that.
A successful clinical evaluation report hinges on the quality of clinical data and the processes for collecting and analyzing it. To do so, researchers use Case Report Forms (CRFs) completed by investigators for each patient during the investigation.
In the past, CRFs from a clinical study would be completed on paper, packed into boxes, and shipped from the study location to a secondary location for analysis. But today, a growing number of medical device companies are going paperless and using web-based Electronic Data Capture (EDC) systems to collect, store, and manage clinical data.
EDC systems give clinical study managers the ability to streamline the data collection process, capture more accurate data, and enhance data security and accessibility - all while saving time and reducing the cost of completing a clinical study. EDC systems are also an essential pairing with a well-developed quality management system to ensure that best practices are being followed.
With SMART-TRIAL by Greenlight Guru, medical device companies can create customized electronic case report forms (eCRF) and digitize data collection for clinical investigations, in-human studies, and post-market surveillance activities.
The post-market surveillance (PMS) plan is part of a device’s required technical documentation, detailing your strategy for continuously monitoring and collecting data and safety information on the device. The plan is part of the requirements for a PMS system, and is intended to outline the criteria for the benefit-risk assessment of the device and processes for:
Additionally, the PMS plan is used to determine whether or not a post-market clinical follow-up plan (PMCF) is required.
Article 84 requires that the PMS system is based on a plan. However, the details of the plan are specified in Annex III, 1.1.
A compliant PMS plan should consider information concerning serious incidents, records of non-serious incidents, available data on side-effects, information from trend reports, any feedback or complaints provided by users, distributors or importers of the medical device, and publicly available information about similar devices.
Annex III of EU MDR requires the following topics to be covered in the PMS plan:
Your PMS plan must be established and documented prior to placing the medical device on the EU market for the first time, and updated as necessary during its lifecycle.
Post-market surveillance is a defining pillar of MDR. Throughout the regulation, we see many ways the PMS system touches or feeds into every part of the total product lifecycle, including the ongoing risk management and clinical evaluation processes.
If that wasn’t enough, the PMS plan must also address the processes used to collect and assess the massive amounts of data produced for a single device. This can be cause for concern among manufacturers, especially for those using a paper-based data collection process which carries high risk of missing and erroneous data.
SMART-TRIAL by Greenlight Guru makes it much more efficient to collect PMS data with direct data capture (DDC). Our electronic data capture (EDC) software lets medical device manufacturers seamlessly enter clinical data contemporaneously (during visits) or at a later point in time. Designed to fit MedTech needs, you don’t need technical skills to get started. Our ready-to-use templates, modules and features will help you to easily design the optimal clinical study.
Another benefit of our EDC software is that it allows clinicians to collect patient reported outcomes electronically on any device, thanks to bring-your-own-device (BYOD) capabilities. Our clients make full use of the ePRO capabilities by tailoring it to their clinical study needs as they solidify their device’s PMS plans.
A post-market surveillance report (PMSR) is a summary of the results and conclusions drawn from the data generated as part of the PMS plan. As part of a device’s technical documentation, it primarily serves as proof of your compliance with MDR requirements for post-market surveillance.
Post-market surveillance reports are used only for Class I devices, as opposed to the periodic safety update report required for higher-risk device classes.
Technical Documentation on Post Market Surveillance (Annex III 1.2.) or the equivalent for custom made devices (Annex XIII, Section 2).
Article 85 states that a PMSR must contain information summarizing the results and conclusions of the post-market data generated by the PMS plan. It also must be presented with a rationale and description for any preventive and corrective actions taken.
Additionally, while the PMSR is not required to be part of the feedback systems from the 8 or 9 processes laid out in Article 83, it may be beneficial to include status updates on each process for consistency’s sake.
The PMS report can be updated whenever the manufacturer considers it necessary and/or delivered upon request by an authority. But that means it must be produced/updated from time to time. At least once every three years is recommended.
One of the most significant thematic changes in MDR is the requirement of manufacturers to now proactively gather input and data about device safety and clinical efficacy. Doing so requires your team to proactively collect information about safety issues, like adverse events (AEs) and severe adverse events (SAEs), which can be done by conducting customer surveys.
Depending on the PMS plan, surveys can be conducted with distributors, customers, and other actors that might have knowledge about safety issues or AEs. Surveys can then be scheduled out and performed routinely to identify any new events that originate in the market. This procedure for the constant monitoring of AEs should also be connected to your QMS, particularly for CAPA procedures..
With Greenlight Guru’s eQMS platform, risk management activities can be linked to ensure full traceability. Additionally, SMART-TRIAL by Greenlight Guru was built with AE reporting modules that make it easy for clinical investigation teams to document, categorize, and report on AEs, SAEs, and medical device deficiencies in clinical investigations.6
While traditional EDC solutions require users to create a separate form or eCRF for reporting an AE/SAE, SMART-TRIAL by Greenlight Guru gives investigators access to ready-to-use AE form templates that reduce set-up time and eliminate duplicate documentation.
The Post-market clinical follow-up plan (PMCF) specifies the methods and procedures used to proactively collect and evaluate clinical data on a device’s performance and safety. As part of your technical documentation, PMCF is connected to and used to update the PMS plan and CER. It also serves as the template for your PMCF report.
The goal of PMCF is to identify previously unknown side-effects, assess emergent risks, and prevent off-label misuse. This data can be captured through general PMCF activities, such as gathering feedback from end users and information from scientific literature.
However, in order to substantiate the data, it often is necessary to use specific PMCF activities—higher-level operations which can be used to scientifically illustrate safety and clinical performance, often based on case-specific data.10
These PMCF activities include:
Post-Market Clinical Follow-Up activities are required by Part B of MDR’s Annex XIV, and further guidance and a template are available in the guidance document MDCG 2020-7.13
The PMCF is a formal activity and cannot be performed in an ad hoc manner. You’ll need to create a post-market clinical follow-up plan that outlines the process you intend to use to gather and evaluate data for your PMCF evaluation report.
Generally speaking, your PMCF plan will have seven sections:
By definition, post-market clinical follow-up activities occur after a medical device has been placed on the market. However, PMCF plans are part of the PMS system, and should there be any corrective actions taken as a result of the clinical studies, the PMCF plan should be updated to reflect those changes.
A common pitfall for medical device companies planning their PMCF activities are communication breakdowns, such as the need for approval of ethical committees, as well as data silos that prevent key stakeholder opinions from staying connected. PMCF planning is a time-consuming task and the increased cost from this step is often a surprise for medical devices companies with limited PMCF experience.
With SMART-TRIAL by Greenlight Guru, you can use specific templates engineered for medical device data collection, reusable across products and markets. Your team can make generic product-related questions for safety and performance. Also, you can select specific scales to track both.
You can also benefit from the centralization of both your clinical data and your quality management system data, thanks to Greenlight Guru’s industry-leading eQMS solution. Linking all these items in a single workflow environment means you won’t be looking for missing documentation, lost signatures, or any of the other frustrations that come with outdated paper-based tracking.
The Post-market Clinical Follow-up Report is the structured summarization of the resulting data from the PMCF plan. Recording and reporting of adverse events and serious adverse events is a key aspect of a successful clinical investigation and staying on top of regulatory changes is a must.
PMCF reports are required under Annex XIV Part B of the MDR.2 Further guidance can be found in MDCG 2020-8, which outlines the reporting requirements and provides a template.
PMCF activities conducted for your device must follow the latest requirements for GCP (Good Clinical Practice). As part of GCP, you are required to notify competent authorities of serious incidents that were previously left undocumented, such as previously unknown side-effects. Additionally, you’ll need to clearly describe this incident in the product documentation prior to introducing your device into the EU market.
Just like PMCF plans, the PMCF reports will naturally come during your post-market surveillance phase, and will subsequently require being updated whenever appropriate.
One of the critical quality requirements for both clinical investigations and PMCF under the MDR is compliance with GCP. To ensure that the data collected in a PMCF survey complies with the quality standards of the EU MDR, sponsors have to use solutions that can fulfill the ISO 14155:2020 requirements for electronic data capture.
This means that if you use survey software that does not comply with ISO 14155:2020, you risk not being able to use the PMCF survey data in your clinical evaluation report. Which then can potentially lead to a loss of CE mark.
To avoid this, you’ll need to ensure your EDC software provider can:
With SMART-TRIAL by Greenlight Guru, you can rest assured knowing that our EDC solution is prevalidated and compliant with both ISO 14155:2020 and GCP. It’s also why our medical device-specific solution is designed to stay up-to-date with the latest FDA, ISO, and EU MDR guidelines for post-market and clinical study needs.
Regardless of your device class, all MedTech companies need quality clinical processes that produce and collect high-quality clinical data. And for good reason—clinical processes are continuous and critical to ensure your device is safe and effective throughout the product lifecycle. It’s also the reason why you need the right partner for your EDC and QMS solution.
With SMART-TRIAL by Greenlight Guru, you’ll leverage the only Electronic Data Capture (EDC) platform designed for MedTech manufacturers that fits the future of the MedTech industry and its regulatory framework. Users also gain access to an in-depth, pre-validated toolbox for Post-Market Clinical Follow-Up (PMCF), Post-Market Performance Follow-Up (PMPF), Clinical Investigations, and Clinical Performance Studies.
And of course, Greenlight Guru offers the only Quality Management Software designed by medical device professionals specifically for medical device professionals. Our comprehensive, out-of-the-box solution is based on the latest industry standards and regulations, as well as best practices of medical device market leaders.
Want to learn more about how SMART-TRIAL by Greenlight Guru can help you? See a personalized demo.