Despite the progress your company has made in preparing for the MDR, don’t overlook how these easy-to-miss factors affect your work.
With the Medical Device Regulation (MDR) delayed until May 26, 2021, we all have some breathing room, but it’s still important to keep full steam ahead. No matter where you are along the preparation and implementation process, the following are important reminders to ensure your submissions are compliant and completed on time.
1) No devices will be eligible for grandfathering under the MDR.
Your legacy products may have been in the market for years without issue. However, submission data must be clinically proven with technical documentation demonstrating device safety and conformity with the MDR, rather than justifying past data that isn’t sufficient from a technical standpoint. While the Medical Device Directive (MDD) approved submissions with supplemental biocompatibility data, all medical device submissions must show robust data to satisfy the MDR’s newest standards.
2) MDR requirements will hold your documentation to the latest standards, but your testing procedure may not be held to those standards.
While you will need to submit complete data packages for all of your devices, the upside is you may not be required to undergo completely new testing to satisfy the standards enforced under the MDR. Regulators will accept testing documentation that doesn’t follow the latest standard, as long as the resulting data still complies.
3) Identifying carcinogens, mutagens, reproductive toxicants and endocrine disruptions applies at 0.1% or above to all invasive devices, regardless of contact duration or class.
Under the MDD, if a device were to be in contact with a patient for less than 24 hours, these identifications wouldn’t face the same level of scrutiny. However, under the MDR, there will be less distinction regarding risk, based on the duration of exposure. Many manufacturers will be directed back to chemistry testing to find answers to questions they haven’t answered before.
4) Expect a shortage of biocompatibility specialists in the foreseeable future.
During the transition to the MDR, staffing for both normal operations and MDR operations put tension on the labor market for biocompatibility specialists. With limited capacity both internally and with contracted partners, it’s essential to plan accordingly and identify areas where you may require additional support early on.
5) Capacity in testing laboratories is limited, which could backlog your submission timeline.
The longer you wait to communicate your submission strategy and timeline with testing labs, the longer it will take to secure a spot in line. Some contract research organizations that perform such testing have taken steps to expand their capacity for MDR preparation, but there are no guarantees.
6) The number of notified bodies for the MDR is greatly limited.
Currently, there are only 13 approved notified bodies. This is a drastic reduction from the capacity under the MDD, when there were more than 100 notified bodies. It’s also important to note that once a notified body is approved under the MDR, it will no longer accept submissions under the MDD.
MDR readiness is no small feat. Clearing up common misconceptions and identifying potential hurdles enables progress, there is always more to learn. If you’d like to share additional tips or info that manufacturers should know as they prepare for MDR, please reach out on our LinkedIn page.
WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps our partners improve the productivity of advancing healthcare products through cost-effective and efficient solutions. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 3,900 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that “every drug can be made and every disease can be treated.”
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