Staying on Top of MDR, IVDR, and Surveillance Requirements With Cloud QMS
Getting new medical equipment on the market is only half the struggle in today’s regulatory environment, which is always evolving. Even when devices are released, more work still needs to be done, such as the beginning of post-market surveillance (PMS).
The Importance of Post-Market Surveillance in Medical Device Manufacturing
Manufacturers of medical devices must carry out post-market surveillance once they are commercially available, according to regulatory authorities in the majority of markets, including the United States and the European Union (EU). A crucial step in the product lifecycle is post-market monitoring, which requires medical or in vitro diagnostic device manufacturers to continuously track the device’s performance and compile empirical data to back up the products’ efficacy and safety. Additionally, it enables these firms to swiftly put the required remedial measures into place and lessen unfavorable situations.
In the past, reporting major incidents such as device malfunctions and patient injuries has been the focus of the PMS requirements for medical devices. The introduction of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) has shifted toward more proactive planning and monitoring.
What are MDR and IVDR and why are they important?
With significant scientific and technological advancements, there was a need to come up with a more comprehensive and strict set of regulations to govern the production and distribution of medical devices. As a result, the European Union Medical Device Regulation (EU MDR) and In vitro Diagnostic Device Regulation (EU IVDR) were approved in March 2017 by the European Council and in April 2017 by the European Parliament.
MDR entered enforcement on May 26, 2020, and IVDR on May 26, 2022. The MDR was created to ensure the efficacy and safety of medical devices on the European market. All businesses that want to sell their goods in Europe are required to abide by these rules.1
Post-market surveillance requirements of MDR and IVDR
The process through which medical device producers keep an eye on their products while they’re on the market is called post-market surveillance. It involves the methodical development and gathering of data about the product and its actual use, which producers can then use in a variety of methods, such as:
- Discovering safety issues with the design or use of the device
- Accurately understanding how the device is used once it’s on the market
- Gathering clinical evidence on device use in the market, to promote commercial use cases or improve product and services
- Collecting information for the development of iterations or new devices
- Complying with regulatory requirements
Navigating Regulatory Changes and Ensuring Compliance
Post-market surveillance is vital because regulators all around the world mandate it. You must monitor your product for its complete lifecycle, including the period it spends on the market.
The transition to the new MDR and IVDR, which establish new rules for placing on the market medical devices (including diagnostics) in the EU, and were adopted in 2017, has been plagued with uncertainty and delays. Many manufacturers are still not ready. This leads to the risk of shortages of many devices in the EU, given the upcoming deadlines for compliance with the new rules and the fact that noncompliant devices will be banned.
Proposed Regulation and Its Implications: Extending Market Access for Medical Devices in the EU
On January 6, 2023, the European Commission issued a Proposal for a Regulation extending the period during which devices compliant with the old EU legislation on medical devices can continue to be placed on the EU market. The Commission has also proposed to eliminate any sell-off restrictions for devices legally placed on the market during the transition time.
The Proposal has been widely welcomed by industry representatives while not being immune from some criticism. It must be adopted by the European Parliament and Council through an accelerated co-decision procedure before it can become law. Medical device manufacturers selling in the EU should monitor the legislative process initiated by the Proposal, as well as guidance issued on the interpretation of its provisions.2
New requirements in EU MDR
Every medical device must have appropriate clinical evidence to establish conformity, depending on the device class, according to a new rule in the EU MDR. Manufacturers marketing current technology without readily accessible clinical data will be significantly impacted by this new requirement.
Changes to IVDR
The IVDR is in effect as of May 26, 2022. The European Parliament and Council decided in January 2023 to extend the transition period in stages, starting with high-risk in vitro diagnostics on May 26, 2025, moving to lower-risk in vitro diagnostics on May 26, 2027, and ending with certain provisions involving devices made and used in healthcare facilities on May 26, 2028.
IVDR Timeline:
- May 25, 2025: All IVDD CE certified devices must comply with the IVDR. Class D self-declared IVDD devices must comply with the IVDR.
- May 26, 2026: Class C self-declared IVDD devices must comply with the IVDR.
- May 27, 2027: Class B and A sterile self-declared IVDD devices must comply with IVDR.3
Best practices for meeting new IVDR requirement
As the functionality of medical devices continues to evolve and become more complex, organizations need to examine their transition plans to see how they might adjust them and decide how to collaborate with outside parties in time for the new deadline.
Here are some considerations in your MDR/IVDR planning:
Communicate: During the compliance wait period there were probably a few strategic changes within your company or to the product(s). Determine what’s changed through your talks with other team members within your company. Understand which key modifications the plan needs to be readjusted for. The more collaboration you can foster about what meaningful change entails, the better the business will be at implementing the changes together.
Some typical questions to bring up might include:
- Are the business and product strategies still applicable, or have they changed in a way that will impact compliance with MDR/IVDR?
- Are the distributors and economic operators you were planning to work with in Europe still available? What is their transition status, and what are their plans?
- There are emergency use authorization (EUA) plans in the U.S. that a lot of medtech companies pivoted to support. Will those be launched in Europe as well?
Other changes that can impact strategy are outlined in the International Accreditation Forum (IAF) Mandatory Documents (IAF MD) 9:2017, Section 9.6, which include:
- A change in company ownership.
- Extension to manufacturing and/or design control—which now includes figuring out how to make room for social distancing.
- Modification of the site operation involved in the manufacturing activity, such as relocation of the manufacturing operation to a new site or centralizing the design and/or development functions for several manufacturing sites.
- Modifications to special processes, such as a change in production from sterilization through a supplier to an on-site facility, or a change in the sterilization method.
- Change in the defined authority of the management representative that impacts the quality management system effectiveness, regulatory compliance, or the capability and authority to ensure only safe and effective medical devices are released.
It’s a good idea to review the MDCG document as you identify the changes relevant to your organization.
Start Piloting: Beginning the transition process is difficult, especially if there may still be issues and ambiguities with the new rules that existed before the pandemic. One approach to make the task less overwhelming is to start blocking time to work on your plan. Look ahead a week, two weeks, or a month. However full your calendar is, block off some time for MDR/IVDR transition preparation.
The following starting points can help you decide how much time you need to plan for:
- Start with products highest in revenue or are 80% likely not to change.
- Create a list of the items most volatile to change. Set this list aside to address at a later date when you’ve made some decisions and are more certain about the changes you will implement.
- Start laying the groundwork for new products. Talk with your development teams and identify the new pieces they should be integrating right now that will be necessary for complying with the new regulations.4
Streamlining your post-market surveillance with Cloud QMS
Managing all the paperwork and clinical data needed for post-market surveillance might be overwhelming, especially if you’re still relying on manual, antiquated systems. Adopting a cloud-native quality management system, such as Arena QMS, allows you to electronically link your post-market surveillance papers and other crucial information to the whole product record. As a result, compliance risks are diminished and there is more visibility, traceability, and control across the entire lifecycle.
You can use high-quality templates from Arena to construct your PMS plans and reports, doing away with any guessing on your part. Your PMS data may be readily downloaded and added to your technical file so that you can maintain EU compliance when it’s time for a conformity assessment or in the case of an unforeseen audit.
Staying Informed and Simplifying Compliance for Notified Bodies
The Notified Bodies will want your processes to be set up in a way that is simple for them to follow given the amount of work that has to be done in a short amount of time as well as the scope of changes with the new regulations. Companies must be able to clearly describe their own products, operations, and transition situation to customers.
The most important things to remember are to keep moving forward while staying educated, reviewing your strategy periodically, and continuing to change how you perceive the shift.
Resources Cited
Joseph Prock