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Preparing for MDR: Don’t Forget About Class I Reusable Devices

Preparing for MDR: Don’t Forget About Class I Reusable Devices

Class III medical devices are getting a lot of airtime in the discussion about the EU Medical Device Regulation (MDR) preparation, but we can’t forget about reusable devices. Under MDR, there’s a new subclass for Class I reusable devices (Class Ir), such as surgical instruments and endoscopes, putting such devices under a higher level of scrutiny and introducing new regulatory oversight. Extensions won’t be granted for Class Ir, and grandfathering in legacy devices will be strictly prohibited. As of May 26, 2020, every Class Ir device must have an MDR CE mark to be permitted in the market.

While the standards of the current Medical Device Directive (MDD) place emphasis on validation goals, and International Standards outline how to build a study design, each member state has developed a different set of interpretations and expectations, because validation standards have not been enforced uniformly. In general, it was assumed that device manufacturers were responsible for interpretation, execution and self-determination as to what a validation entailed to meet MDD compliance.

Under MDR, it is not permissible for OEMs to self-designate devices that fall into the Class Ir category. In order to obtain a new CE mark for a Class Ir device, a detailed technical file that proves safety and efficacy of the cleaning, disinfection and sterilization processes outlined in the device’s instructions for use (IFUs) must be submitted. Without a standard definition of “clean”, the responsibility falls to device manufacturers to ensure cleaning, disinfection and sterilization instructions are adequate and comprehensive. Regulators expect manufacturers to validate their instructions to demonstrate a reliable and repeatable process even under worst-case scenarios.

Technical File Review

First, take a look at the technical files for each of your Class Ir devices. Legacy devices that have been on the market for a long time will be more laborious, so start with these. Keep in mind, notified bodies will not rely on historic product performance or reviews to meet MDR requirements—you need data.

Within the gap analysis, evaluate historical data and identify missing or outdated pieces in device design history files. You will need to confirm that validations exist in the design file that support their IFU claims. Keep in mind that if a product family consists of multiple catalog numbers and SKUs, validation evidence must be documented to cover all of those devices. If gaps are identified, engage a contract research organization (CRO) to recommend appropriate validation tests that can rectify gaps and provide supplemental data. Working with a laboratory testing partner will help develop experimental design and validation methods that are compliant with the latest guidance and regulatory documents.

Validation Studies

To prove the robustness of a process design and to validate that normal process variables do not impact a product’s acceptance criteria, a cleaning validation should be executed. A validation package should prove that the manual or mechanical cleaning methods allow the device to be reprocessed effectively, and for devices cleaned in healthcare settings, that they clearly convey proper instructions for the user.

The goal is to generate objective evidence and documentation that the processing methods consistently produce predetermined results. Robustness, repeatability and reproducibility are key validation principles to employ:

  • Robustness: A study needs to test worst-case conditions.
  • Repeatability: Sample sizes need to be statistically sound, and outputs and data consistency should be confirmed.
  • Reproducibility: Multiple efficacy cycles should be performed to account for variations in the test system, which further supplements data integrity.

There are various types of validation services that can be used to prove the safety and efficacy of cleaning, disinfection and sterilization processes.

  • Protocol development: A custom protocol should be written for each study, tailored specifically to the device and instructions for reuse.
  • Cleaning efficacy studies: Manufacturers must validate the efficacy of recommended cleaning processes. Following the manufacturer’s cleaning instructions, cleaning efficacy studies test those processes with simulated use, artificial soils and worst-case parameters to confirm test marker acceptance criteria.
  • Sterilization efficacy studies: Manufacturers must provide healthcare facilities with detailed sterilization instructions for their particular medical device. Sterilization parameters are tested to determine capability of producing a sterility assurance level (SAL) of at least 10-6.
  • Dry time validations: Manufacturers must provide healthcare facilities with an effective dry time to be used in conjunction with the required steam sterilization cycle. Drying cycles are tested to prove the cycle works according to the given parameters.
  • Support for functionality studies: These studies involve exposure to multiple cleaning, disinfection and/or sterilization cycles as a prelude to the functionality studies required to determine the useful life of a device.
  • Disinfection efficacy studies: Disinfection studies determine the effectiveness of a process by evaluating the ability of the selected disinfectants to reduce microorganisms to acceptable levels on the medical device.

Five Rules of Testing to Keep in Mind

  1. At a minimum, proper test controls and two relevant markers are required. Controls include the positive and negative device control, as well as the positive and negative sample control. Common endpoint markers include protein, hemoglobin, carbohydrate and total organic carbon (TOC). The test markers identified should be present in the applicable artificial soil chosen.
  2. Simulated use cycles need to reflect the life of the product or run a minimum of six cycles. The complexity of the product design, lifecycle, and product risk profile are all inputs into cycle determination. Additionally, simulated use should take into account all the processes in a reuse cycle. This includes cleaning but may also include disinfection or sterilization based on the product IFU.
  3. Recovery efficiency should be performed for all studies. Extraction methods have their limitations on the ability to displace residual soil into solution. As a result, the recovery efficiency validation documents the effectiveness of the extraction process and generates a correction factor that is used in the calculation when determining total marker endpoints.
  4. Removal of cleaner and detergent residuals must be tested and evaluated.
  5. Cleaning efficacy and disinfection efficacy studies are performed independently. A cleaning validation and its construct is separate from a disinfection validation. As such, independent protocols and reports for each must be generated to document the effectiveness of each reprocessing step.

Cost of Re-Use Validation Failure

Improperly conducting a study is costly from a time and monetary standpoint. Failing to provide adequate validation may result in slowed time to market, increased total cost of preclinical testing and marketshare loss—to name a few consequences. Watch out for the following common reasons studies fail:

  • Not selecting worst-case test soil
  • Not using worst-case device and parameters
  • Not including proper test controls
  • Not using relevant markers
  • Not including accumulation cycles
  • Recovery efficiency not performed or too low
  • Performing cleaning and disinfection together as one validation
  • Not demonstrating and documenting appropriate test soil drying times

Team Up with a CRO

How you go about selecting a testing partner is just as important as the testing itself. Ask questions before you sign contracts. You want to choose a CRO that is knowledgeable on the ever-changing technical and regulatory landscape. Study designs need to incorporate industry best practices, lessons learned, process validation principles and current regulatory guidelines. While general scientific principles are important, you also want to work with a partner that keeps your organization’s best interest in mind. There is no one-size-fits-all approach to testing, so make sure a CRO considers your unique device and its IFU, the function of the device’s design, the cleaning complexity, device materials and criticality.

Finally, keep in mind that notified bodies must go through a new designation and notification process before they will be eligible review your device’s technical file and approve a CE mark. With the number of notified bodies shrinking, ones that you’ve used in the past may not make the cut or may not have capacity. Also, note that increased specialization of notified bodies is expected. With these factors in mind, it is a wise move to get in touch with your notified body—and CRO—as soon as possible, as the industry anticipates capacity constraints. Contingency plans and proactive communication and scheduling will be important.

May 26, 2020 will be here before you know it. Thoughtful planning, partnership and attention to detail will be your keys to success in getting your Class Ir devices in compliance with MDR. The tips provided here will help get you started down the right path.

Got Your Game Plan? The OEM Playbook to Navigating Preclinical Device Testing Under MDR and ISO 10993-1

Got Your Game Plan? The OEM Playbook to Navigating Preclinical Device Testing Under MDR and ISO 10993-1

When the Medical Device Regulation (MDR) replaces the Medical Device Directive (MDD) in 2020, requirements for medical devices in Europe will present greater regulatory hurdles. In addition, ISO 10993-1, created by the International Organization for Standardization (ISO) Committee and mandated by both the FDA and MDR also introduce new requirements for pre-clinical safety device testing. Medical device manufacturers are feverishly working to navigate the changes and develop their preclinical device testing strategies to overcome what’s not just a regulatory hurdle, but a business challenge.

OEMs have just over a year until implementation of the new regulation. All medical devices — even legacy products that have been on the market for years — will require submissions that are supplemented with new data and updated evaluations. It is estimated that more than half a million different devices CE marked under the MDD must transition to comply with MDR. With much to be done and a shrinking number of notified bodies, time is of the essence. The best way to try to stay ahead of the curve and avoid costly regulatory delays is through thoughtful planning and partnership.

Requirements: What you Need to Know

The new and updated regulations emphasize the role that complete evaluations with robust supporting data play in ensuring medical device safety. ISO 109931 has increased the importance of materials characterization, physical and/or chemical information, and risk assessment to support safety and steer a test plan to meet biological endpoints. As directed in ISO 10993-1, regulators will be looking for detailed chemical information to support the direction of the biocompatibility test plan, and if sufficient information is not provided, additional testing, like extractables and leachables (E/L) studies, will be required. If extractables testing is conducted, regulators will be looking for extraction conditions that demonstrate a device has been challenged (e.g., use of aggressive solvents representing a wide range of polarities, elevated temperatures, and extended timeframes). The expectation is that all chemicals are identified, so avoiding unknowns in chemistry reports is paramount. If unknown chemicals are listed in a report, be prepared for regulators to require you to complete the identification — a complete materials characterization cannot exist with unknowns.

With increased emphasis on chemical characterization, biocompatibility testing alone cannot be relied on to support device safety. Biocompatibility testing can help identify local and systemic effects of your device in a living system, but it only tells part of the story. Detailed chemistry testing and a toxicological risk assessment are necessary to provide information about chemicals present even at minute levels that could be harmful.

Where to Start

Internal due diligence is necessary throughout the testing and submission process. Fire drills, headaches, and delays can be kept at bay with a planful approach and cross-functional team that is apprised of the regulatory changes and business impact. Your internal team should compile existing data on the materials that make up your devices, including adhesives, additives, colorants, polymers, manufacturing aids and more. Procedures used in the manufacturing and sterilization processes should also be reported. This data will help you and your contract research organization (CRO) evaluate what tests are necessary to verify safety and whether a gap analysis should be performed before testing begins.

Sequence of Testing

There are three phases involved in a complete biological evaluation under ISO 10993-1 and MDR — chemical information and/or chemical characterization, toxicological risk assessment, and biocompatibility testing — ideally in that order. Chemical characterization involves exposing the device to aggressive solvents that identify and quantify expected and unexpected chemical constituents contained within the device — an extractables study. Extractables studies are followed by toxicological risk assessments which use the information found in chemistry reports to establish a margin of safety for each chemical and determine what additional tests are needed to further mitigate any safety concerns. The final stage is biocompatibility testing, which looks at how living cells react to the device.

Historically, device manufacturers have been able to reach successful submission with biocompatibility testing alone, but more often than not, this is no longer the case. Beginning with biocompatibility testing is not a best practice because complete chemical characterization often can meet biocompatibility endpoints, such as genotoxicity or subacute/subchronic toxicity; therefore, using chemistry data and risk assessment to develop a biocompatibility test plan can often save unnecessary use of animals in testing and costly test article.

How to Vet a CRO

Outsourcing testing to an experienced CRO that offers a full range of preclinical device testing services can be instrumental in accelerating the process and getting your devices in front of regulators before others. Refer to the following cheat sheet to help determine who to trust with your testing program.

Q: Do you have the capabilities to conduct chemical characterization, toxicological risk assessments, and biocompatibility testing in-house? Enlisting a CRO that has all three capabilities in-house increases efficiency, allows you to address required endpoints, and helps eliminate information gaps. Watch out: If their answer is no, you may have to resort to piecemealing your testing, which can lead to longer timelines, increased cost, miscommunication between parties, loss of information altogether, and unknown impurities getting missed in your chemical reports.

Q: How often do you report unknowns in your chemistry reports? On average, what percentage of compounds in your reports are unknowns? Demand transparency. Working with a chemistry partner that reports unknowns will be problematic. Watch out: Reporting unknowns may indicate that the CRO does not have the expertise, instrumentation and/or the commitment to perform complete chemical characterization. This may cause regulators to reject your submission or issue requests for additional information (AIs). Unknowns are expensive. On average, repeat testing can cost more than $75,000 and 27 weeks of time.

Q: Are your analytical methods sensitive enough to detect constituents at a level low enough to be properly evaluated in a risk assessment? Analytical method sensitivities illustrate the precision and accuracy of the CRO’s equipment and the expertise and experience of their team. Watch out: Extractables reports that include only a small number of reported compounds may indicate that the CRO does not have the instrumentation or expertise necessary to provide complete identification.

Q: What protocol do you follow after testing is complete? Do you provide support after submission? The way a CRO answers this question will speak to their philosophy on customer service. Watch out: If the CRO does not provide follow-up support on the testing that they do, you are on your own if regulators have additional questions or requests. It is in your best interest to select a CRO that will stand by you and their reports.

Q: How do you know your advice is in line with the way regulators are thinking? Staying on top of regulatory changes is one thing — the bigger challenge is understanding how regulations are being interpreted. It’s necessary to spend time watching and interacting with regulators to understand, for example, their expectations on how testing is conducted. CROs with international delegation on ISO committees and that collaborate with ISO by writing standards, participating in round robins, or offering other technical expertise may demonstrate a commitment to getting to know what regulators want on a deeper level. Watch out: Find out if they have international delegates on ISO committees — an indication they may not only know the standards, but also the “why” behind the standards. Also, ask if prospective CROs keep a database of regulatory feedback and questions to track how interpretations change and influence expectations. This intel should be used to advise OEMs on how to prevent requests for additional information.

The regulatory deadlines are approaching quickly. Stay ahead of the curve with strategic planning and partnership.

Q&A: MedTech Industry Still Scrambling as MDR Deadline Nears

Q&A: MedTech Industry Still Scrambling as MDR Deadline Nears

As preparation for compliance with EU MDR should be well underway at most companies that market products in Europe, there is continued buzz about manufacturers being behind the eight ball. In a Q&A with MedTech Intelligence, Sandi Schaible, senior director of analytical chemistry and regulatory toxicology at WuXI Medical Device Testing, shares some advice on how medtech companies should approach their plan for regulatory testing.

MedTech Intelligence: What options do manufacturers have to reach Medical Device Regulation (MDR) compliance?

Sandi Schaible: With the MDR deadline only months away, the industry is scrambling. There are three paths manufacturers can take:

  1. Register the device under MDR. For devices with a good return on investment (ROI) and that wouldn’t benefit from a redesign or upgrade, registering the device under MDR is likely the best path forward.
  2. Develop the next generation under MDR and extend the current product life under the Medical Device Directive (MDD). This is an option to consider if the device has created patient safety issues, is falling behind competitor products, or if it undergoes a hazardous sterilization method, such as ethylene oxide (EO), that could be substituted with another method instead.
  3. Retire the device in Europe. Reasons to consider ending the life of a device in Europe include poor ROI, quality issues or obsolescence due to next-gen devices.

If you’re going down the first path, once all necessary product information and technical file data is gathered, it’s time to develop your test plan. Many manufacturers opt to outsource their regulatory testing needs to a lab or CRO to accelerate the process and get devices in front of regulators as soon as possible. If you’re going to work with a partner, give them visibility to forecasts, intervals, and timelines to help ensure they have the capacity to support your testing and timelines. Being transparent and forthcoming with details will expedite the process and set you up for success.

MTI: What are the advantages of outsourcing testing?

Schaible: Outsourcing pre-clinical device testing can add credibility to device submissions and provide reliability in the timeliness and success of the process. Regulators want to see that you have not introduced any biased views in chemistry reports and technical files; working with an unbiased third party is one way to accomplish this. Working with an outside lab also gives you access to insider knowledge. Labs and CROs have visibility to all types of devices, standards, regulations, questions and requests, which allows them to learn constantly and adapt quickly to changes in the regulatory landscape, as well as respond efficiently to questions, which can allow for faster approvals. Furthermore, when you work with a qualified lab, you’ll have access to experts who specialize in chemistry and toxicology; generalists may not have sufficient experience with E/L testing medical devices, identifying unknown chemicals, or addressing the immune response or toxicity of a specific chemical. Outsourcing also helps ensure testing is done sequentially and that all biological endpoints are met.

For a list of questions and considerations that will help you decide who to trust with your testing needs, read “Preparing for MDR: Partner Up.”

MTI: What are the advantages of performing testing in-house? What steps do manufacturers need to take to execute this effectively?

Schaible: In-house pre-clinical device testing can be advantageous because it allows device manufacturers to have total ownership and direct lines of communication. As the industry faces tight timelines and limited testing capacity, being able to have ownership over timelines and prioritization can be a relief for manufacturers. Furthermore, communicating within your own organization may be less time consuming, if it is well organized. With May 26, 2020 quickly approaching, every day counts.

For manufacturers to make in-house testing a reality is no small feat. If you don’t already have an in-house lab, it’s probably too late to build one. And running a viable testing facility requires an experienced team. This team needs to be up to date on the latest standards and regulations, have experience with extractables/leachables studies, and have written risk assessments for medical devices in the past. Building this from scratch is a significant investment in time and money.

MTI: What advice do you have for manufacturers that are behind?

Schaible: If you’re behind, now is the time to lean more on lab testing partners, if they have bandwidth. Be a good partner by being prepared to answer their many questions about your device so they are able to develop a solid test plan and accurate quote. Providing all of the information asked of you right away will save time, help prevent denied submissions due to inadequate results, and avoid increased costs when studies aren’t designed properly.

Be prepared to share the following with your lab right away:

  • Existing data
    Many devices entering the lab have already undergone some level of testing. If you have existing data, such as aging data, providing this can expedite the test design process by helping scientists understand the make of the device and if there are any compatibility concerns.
  • Parts and composition
    Device composition ranges drastically from products made up of hundreds of small pieces to one large part. Describing how the device comes together and how many parts it’s made of allows the lab to determine correct test specifications.
  • Size, thickness and surface area of the whole device, as well as patient-contacting portions
    Detailed dimensions are necessary because the extraction ratio will depend on wall thickness. Surface area information is important for a lab to be able to provide sample numbers required for the testing. And labs need to know if your device can be cut into pieces.
  • Purpose, category and patient contact time
    Communicating how the device will interact with the patient will aid in creating boundaries and expectations in overall test design. Labs need to understand, for example, where devices contact the patient, the length of exposure, temperatures and fluids the device will contact, etc.
  • Materials, colorants, pigments, adhesives, additives, polymers and manufacturing aids
    It is important to detail device materials so that appropriate test methods, solvents, temperatures and extraction times are selected.

MTI: What are special considerations manufacturers should be aware of related to drug delivery combination devices?

Schaible: Manufacturers of drug delivery combination devices face are not exempt from MDR, and the combination of a medical device with a drug brings added complexity. Mitigating concerns over the success of these combinations will require an understanding of both pharmaceutical and medical device regulations. Both extractables and leachables studies will be expected, as well as the evaluation of compatibility between the device components. Regulators will look for clear awareness of the impact of the drug on the device and vice versa.

MDR Countdown: Know Your Options

MDR Countdown: Know Your Options

MDR is just months away. To prepare for the sweeping changes in regulation, medical device manufacturers around the world are streamlining their product portfolios and rushing to complete pre-clinical device safety testing. It’s a daunting process that runs the risk of products not meeting compliance and being pulled from the European market, but the good news is that there are steps you can take today to make sure you’re ready.

First, now is the time to rationalize your product portfolio. Start by mapping out each of your products and organizing them based on their age, how many generations are on the market, any quality issues that have arisen from them, and the costs that will be incurred with continued production.

The goal here is to streamline your portfolio as much as possible. You might have some products that can be retired because you’re producing newer versions of them. Or, if a product has had past performance problems or is not satisfying your desired ROI, now is the time to decide whether it’s worth continuing to market and sell it in Europe. For products you’re pulling off the market, we recommend consulting with your quality, regulatory and legal teams to make sure you’re removing the product effectively and with low risk.

For the products that have made it through your rationalization process, there are two paths to take: prepare to register them under MDR, or plan to develop their next generation according to MDR guidelines.

To get your device ready for registration, you’ll need to compile data and run tests on its compositional elements. In doing so, you’ll improve the likelihood that your product successfully passes MDR certification. The first step is for your internal team to compile existing data on the materials that make up the device, including adhesives, additives, colorants, polymers, manufacturing aids and more. The procedures used in the manufacturing and sterilization processes should also be reported. This data will help you evaluate what tests will be necessary to comply with the new regulation.

It’s important to note there are three phases of testing involved in a complete biological evaluation under ISO 10993-1 and MDR: chemical characterization, toxicological risk assessment and biocompatibility testing.

Chemical characterization, also known as an extractables study, involves exposing the device to aggressive solvents to identify and quantify chemical constituents contained within the device. Toxicological risk assessments, which use the information found in chemistry reports, establish a margin of safety for each chemical and determine what additional tests are needed to further mitigate any safety concerns. Biocompatibility testing looks at how living cells react to the device. (Note: if chemical characterization meets some biocompatibility endpoints, it may not be necessary to do biocompatibility testing.) Together, these evaluations generate data on the physical and chemical makeup of the device in order to demonstrate its safety and achieve MDR compliance.

Partnering with a lab or contract research organization (CRO) can help you can stay on top of your timelines before MDR goes into effect, as their expertise can serve as a valuable resource in efficiently adhering to the new requirements. Once you’ve begun to work with an outside organization, communication is key: provide a forecast, inform them of what samples they can expect and when, and make sure they have testing capacity. You should also provide them with thorough technical information so they can set appropriate testing parameters. Finally, prepare and provide a test article that is truly representative of the manufactured device to ensure accurate results.

Meanwhile, developing the next generation of your device under MDR guidelines is also an option. This might be valuable to consider if the device has created patient safety issues, is falling behind your competitors’ products, or if it utilizes a hazardous sterilization method – such as ethylene oxide (EO) – that could be substituted with another method instead.

Here too, the data provided to you by a lab can help guide you through the development of the next iteration of products that will meet MDR guidelines. It’s up to you to determine which course of action will be the most effective for your organization.

Getting organized now will help make sure you’re ready for MDR in May. Create a strategy that starts with rationalizing your product portfolio. For the products you’ve identified for continued sale in Europe, consider partnering with an experienced lab to expedite the testing process. You may be hoping Europe will delay MDR implementation, but you shouldn’t count on it. If your company is behind, it’s time step on the gas. For more tips on how to get started, check out “Preparing for MDR: How to conduct a gap analysis.”

WuXi Medical Device Testing offers testing services in St. Paul, Minn., Atlanta, Ga., and Suzhou, China.

Preparing for MDR: How to Conduct a Gap Analysis

Preparing for MDR: How to Conduct a Gap Analysis

With the EU Medical Device Regulation (MDR) drawing near, device manufacturers are under intense pressure to get in gear and evaluate their existing pre-clinical data for compliance. After May 26, 2020, all new medical device submissions will be required to meet the MDR. Medical devices approved under the Medical Devices Directive (MDD) and Active Implantable Medical Device Directive (AIMDD) prior to May 26, 2020 may continue to be marketed until May 27, 2024. Any significant design change to a medical device after May 26, 2020 will be required to meet the requirements of MDR. After May 26, 2024, all devices in EU market are expected to be MDR certified. You may be hoping Europe will delay implementation, but don’t count on it! If your company is behind, it’s time to kick it into high gear. Start the process with a gap analysis.

What’s a gap analysis?

Essentially, a gap analysis identifies data gaps in existing procedures and product portfolios. A comparison of your procedures to the requirements in the MDR will help ensure that your processes generate devices compliant with the new regulation. Gaps in the information provided in product files are identified using the revised procedures. Your products will not be ready for submission to your notified body until all old or incomplete data is rectified. Keep in mind that products with inadequate data packages will lead to lost time, money, retesting, or worse, an all-out product redesign. To begin, build a cross-functional team of internal people from quality, regulatory, R&D, finance, product management, procurement and other departments for a well-rounded understanding of how the new regulation affects your products. Your team must be educated on the regulatory changes before they can conduct thorough evaluations and make informed decisions. Depending on bandwidth and expertise within your organization, it may be possible to complete the gap analysis internally. Otherwise, you can outsource it to a contract research organization (CRO) or a laboratory testing facility that is knowledgeable in performing gap analyses to the current standards and regulatory requirements. If opting for the latter, your respective teams can work together to prioritize products and decide on the best path forward.

Key considerations when performing a gap analysis

Prioritization: Determine the order in which product files will be evaluated. Some factors for consideration include impact of the device not being available to the market, EU device class, and the amount of time since the last submission of documents to your notified body.

  • Impact of the device not being available. For example, devices that could impact the well-being of a large number of patients or devices that are very unique may be prioritized.
  • EU device class. Class I devices have relatively low health risks. However, the documentation for these devices may have significant gaps. Class II and Class IIa devices have moderate health risks but are more likely to require additional time to upgrade their technical files. Class III devices have the highest risk but may require less time to upgrade documentation since these files are reviewed once every five years.
  • Time since last submission. Look at the age of your device to determine where it falls on your list of priorities. Ask: how long has the product been on the market? When was it tested last? If you haven’t tested the product since it was originally manufactured, its technical file data may be noncompliant or outdated. Newer products that have undergone testing more recently may have fewer gaps, requiring less time and effort.

Track record: A history of regulatory success is appealing to regulators and works in your favor. On the flipside, withholding past issues will work against you. Be transparent to avoid unpleasant surprises. If working with an outside lab, this information can also help them make better testing decisions and recommendations.

Changes: You must note in your submission any changes made since you last tested the device. Regardless of whether the change was large or small, it may impact the applicability of existing data. Document changes in manufacturing and sterilization methods, material enhancements, and vendors. Regulators will be looking for supporting documentation that shows changes do not interfere with device chemistry or performance.

Safety issues: Disclose all patient-safety or performance issues that have occurred, and detail how you’ve rectified the problems. This indicates you are dedicated, thorough and take regulatory changes seriously.

With unforgiving timelines and heightened pressures to get through testing fast, outsourcing your gap analysis and testing may be prudent. Labs can be instrumental resources, but they’re not all created equal. For questions and considerations that will help you select testing partners, check out “5 Revealing Questions to Give You Confidence in Your MDR Testing Partner.” WuXi Medical Device Testing offers testing services in St. Paul, Minn., Atlanta, Ga., and Suzhou, China.