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.
