Medical device change control regulations have a lot of boxes to check.
By Matt Lowe, MasterControl
Given the dynamic nature of medical device development, changes are inevitable.
Change control focuses on managing changes throughout a product’s life cycle as a part of current good manufacturing practices (cGMP). Extensive regulations ensure that changes don’t put the safety, reliability and performance of products at risk. Therefore, it’s critical that medical device manufacturers adhere to all of the regulatory change control guidelines.
This article provides four tips for effectively managing change control to remain compliant with cGMP regulations.
1. Know that regulatory changes are coming
The FDA is close to aligning the current cGMP requirements of its Quality System Regulation (QSR) 21 CFR Part 820 with the International Organization for Standardization’s ISO 13485:2016. Once the ruling is finalized, the regulation will be called the Quality Management System Regulation (QMSR) and the techniques used to inspect medical device companies will change.
One of the primary differences is that QMSR will adopt ISO’s greater emphasis on risk management activities and risk-based decision-making. While the current Part 820 explicitly addresses risk management activities in its section on risk analysis within design validation, the FDA said it expects manufacturers to “integrate risk management activities throughout their QMS and across the total product life cycle.”
2. Stay in control to remain compliant
Change is common with life sciences products, but companies can ensure compliance only when making changes in a controlled manner.
Regardless of who is involved in the process, all discussions, meeting minutes, emails, whiteboard notes and the like associated with the change must be included in the change documentation.
For example, all change processes in production must be documented at the time of performance. Then they are reviewed and approved by the quality control unit and other relevant stakeholders. Having all documents, supporting data, and approvals in place during the changes and reviews constitutes a controlled change.
An uncontrolled change refers to modifications made without the review and approval of the quality control unit and other departments affected by the change, which can result in a compliance violation. Uncontrolled changes to any medical device or production processes could impact the quality of a product, jeopardizing the compliance status of the product and the manufacturer.
3. Data management is essential
Change control procedures should include sufficient supporting data to demonstrate that the revised process or change in materials will result in the product retaining the level of quality that is consistent with the approved specifications.
It is difficult and time-consuming to find and retrieve necessary data to support a change and update the documentation when the data is on paper in a filing cabinet. And the proposed change can be delayed by an outdated record or one that does not include its revision history.
Changes typically impact various departments and staff. If other quality areas, such as training, CAPA, supplier management and audits, are not integrated and immediately accessible, the organization will experience miscommunication and possibly a change control compliance violation.
4. Keep regulators in the loop
According to 21 CFR 807, changes may require submitting a new 510(k). The FDA’s “Deciding When to Submit a 510(k) for a Change to an Existing Device” guidance identifies the benchmark for this requirement as when modifications significantly affect the safety or effectiveness of the device.
Effective change control is imperative for companies developing regulated products, and they’re obligated to keep regulators informed of any changes requiring change control procedures. The FDA urges manufacturers to reach out to the agency during the early stages of the change process to eliminate guesswork and duplication of efforts.
When initiating this interaction, ensuring that all data and documentation are up to date, complete and immediately accessible makes this process easier and faster. This gives regulators more confidence in your ability to develop safe and effective products.
Matt Lowe, chief product and marketing officer at MasterControl, is a medical device expert with experience in product development and product management at Ortho Development Corp and Bard Access Systems, a subsidiary of BD. Lowe has launched more than a dozen medical devices, has five patents issued, wrote an FDA-cleared 510(k) and managed a multisite, multiyear postmarket clinical study for orthopedic devices.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.