Why the choice of your MES matters when it comes to meeting changing regulatory requirements and setting up a world-class quality management system (QMS) apparatus!
Medical device manufacturing is a highly regulated industry because products designed, manufactured, and sold has the potential for adverse effects on a patients’ health and safety. Tight regulations mean burdensome documentation throughout the product lifecycle. Most regulatory authorities clearly define QMS requirements for the entire process and the documentation required to ensure the design, production process, end-product, and post-market services are qualified, traceable, and validated.
Industry 4.0 technologies facilitates product design that improves core functions and gathers data from the field/patient to help continuous improvement efforts and product innovation. As products evolve and become more complex, with more electronic components, advanced device software and the ability to receive and transmit more data on patients, regulators must ensure the new devices are safe for use and protect patient’s privacy. Regulators must create regulations to enable automation, innovation, and adoption of Industry 4.0 and do not impede on introducing better products, faster.
Regulators are changing the requirements on manufacturers by graduating to risk-based approaches and reducing the paperwork and repeated validations from the past. For manufacturers, any change in the regulatory landscape translates to increased cost and effort to ensure full compliance.
Changes in the Regulatory Landscape, Explained:
Medtechdive reports the U.S. FDA is making changes to the CFR 21 part 820 regulations to harmonize it with the internationally accepted ISO 13485:2016 QMS standard for medical device manufacturing. This will potentially save hundreds of millions of dollars for manufacturers complying with both FDA and ISO standards and may boost time to market for newly developed products. This effort has been three years in the making and is the first major update to U.S. GMP since 1996. The FDA also states that while most guidelines from the ISO standard are suitable and in sync with its own guidelines, the requirements for labelling and signature/date for records will remain.
The ISO 13485:2016 standard is the internationally recognized and accepted voluntary QMS standard for medical device manufacturing. The ISO 13485:2016 is a modified QMS standard that evolved from the ISO 13485:2003 standard and primarily focuses on the inculcation of risk-based approaches in compliance and quality procedures. It also mandates protecting confidential health information and loss of documentation. The standard lays special emphasis on personnel qualification and documentation. Design control documentation within the standard is aligned with FDA guidelines and explicit new requirements were added for the transfer from design to production. The standard also has specific requirements for purchasing, supplier evaluation, verifications, and failure to meet specs of supplied products procedures. The standard includes using a unique device identification or UDI already required by the FDA, and complaint handling and regulatory reporting, which was not addressed in the 2003 version.
This change happening in U.S. aligns with an internationally accepted standard, which is primarily configured to encourage risk-based decision making in QMS. When the FDA announced the transition from computer system validation (CSV) to computer software assurance (CSA), it showcased the emphasis being put on automation and reduction of documentation, with importance laid on critical thinking, testing and deemphasized tedious documentation. Our post on CSA vs. CSV explains in-depth the impact of moving from a validation focused approach to a risk-based approach. New alignment with ISO 13485 extends the implementation of a risk-based approach to the entire design and manufacturing process.
Deloitte notes that in Europe, changes in the EU MDR and EU IVDR regulations will give national regulators more control and oversight over the medical device industry. With increased oversight at the local level, manufacturers would need to invest significantly in meeting new requirements, adding costs, effort and managing the imminent change so that business isn’t impacted. A major deliverable for manufacturers with the new regulations is to align their portfolios and assess their current risk. Changes may have to be made in operations, purchase, design, and supply based on the new regulations.
The changes in EU regulations are significant because the way products are currently categorized and changes defined. Products which were previously classified as accessories may now be classified as medical devices. This change constitutes massive compliance efforts within an operation and in the extended supply chain. Manufacturers need to set functional requirements based on how these new requirements and increased local oversight affect their operation and product portfolio.
Where the MES fits in the Regulatory Puzzle:
The MES and the extended MOM platform are the foundational building blocks for manufacturers when it comes to Industry 4.0 and digital transformation. In highly regulated industries, the MES you choose can make a great impact on how improvement/transformation efforts align with the evolving regulatory requirements.
For medical device manufacturers there has been a regulatory paradigm shift from validation and extensive documentation to more assurance and risk based. This difference means that while high-risk factors require detailed compliance related documentation, transactional level recording is done by the MES with electronic records created to meet or exceed regulatory compliance.
When it comes to meeting the new U.S. FDA or EU requirements the MES vendor must have the domain knowledge of how the new compliance regulations transition into the application’s functionality and reporting. Manufacturers should learn how the MES supports the functional requirements placed by the changes and the impact on their operation and supply chain. Another aspect to consider is the ease of making changes within the MES. For example, when products classified as accessories are now medical devices, how easy is it to set up controls and protocols to treat appropriately for their new classification? Similarly, how easily can the MES shift from heavy documentation to heavy testing so that compliance-related reporting isn’t affected when manufacturers move software testing and qualification from CSV to CSA?
Depending on how configurable and scalable your MES is transitioning from one regulatory model to another can be relatively straightforward, provided you choose the best MES for medical devices. Using tools like the Gartner Magic Quadrant can help identify the best options for your facility.
The MES you choose should support all compliance and QMS requirements from CAPA to SPC, DHRs to BRs and from Labelling to UDI, while creating automated electronic records in real-time. The MES must comply with ISO 13485:2016 within the QMS and maintain records in accordance with the QMS standard and regulatory oversight for a manufacturing site.
However, the best-in-class application would go beyond, allowing process owners to focus on value adding activities, which can happen only when the MES digitalizes the R&D, quality, and production while providing oversight and control.
An MES that is flexible, agile, and scalable will easily accommodate regulatory changes over time without negatively impacting core operations!