Increasing numbers of device manufacturers are in the process of performing gap assessments to prepare for the new European Union medical device regulations. As noted in our recent blog, these assessments need to examine both existing products and those in development. Costs and resources should be estimated for meeting the Medical Devices Regulation (MDR), which comes into effect on May 26, 2020, and the In Vitro Diagnostic Medical Device Regulation (IVDR), which applies from May 26, 2022.
A question we are hearing from our medical device company clients is, “How do we respond to the outcomes of the gap assessment?”
Many of our clients are identifying similar gaps in the following areas: post-market surveillance (PMS), quality management system (QMS), risk management, technical documentation, labeling, distributor (economic operator) relationships and responsibilities, Notified Body relationships, and clinical data. Device companies should take these next steps as part of a Quality Plan:
- Consider any product rationalization: This involves examining the entire portfolio and determining whether each product’s market value warrants the cost involved in compliance. This rationalization process may involve tough business decisions on what to commercialize in the EU after 2020. For older, legacy devices, the gap may be greater than for newer products, and it can be more challenging to demonstrate that older ones are “state-of-the art.” A critical assessment of existing notified body certificate expiry for each device is an important element of these rationalization decisions.
- Create the value proposition for the organization: Here, the cost of compliance must be balanced against the cost of lost EU sales, also taking into account any collateral costs. For example, if several devices are used together to manage or diagnose a specific disease state, the withdrawal of one may impact the value of the remaining devices to the consumer. This step is critical to product rationalization.
- Quantify the effort to remediate technical documentation files for devices that will be transitioned to the new regulatory environment. We recommend that a company pilot a robust sample of files for documentation that meets the requirements of Annexes I, II and III of each regulation, providing a better sense of the total impact of the changes. The documentation for the pilot should include the Clinical Evaluation Plan and Report for medical devices and the Performance Evaluation Plan and Report for in vitro diagnostic medical devices. Performing these actions for a representative set of products will help determine whether additional work – such as clinical trials or more extensive biocompatibility studies – may be needed, and if so, what resources would be required. For in vitro diagnostic devices, the assessment of the scientific validity of the device is important information to include in the pilot remediation.
- Map the inter-dependencies between the risk management processes, PMS processes, clinical or performance evaluation process and product labeling revisions in the QMS procedures. This will help the organization understand the complexity of the relationships required to maintain a continuous iterative process for risk management. The mapping will reinforce the value of inter-functional communications and logistical integration throughout the organization.
- Quantify the effort to remediate the QMS by piloting the creation of procedures that do not yet exist or need to be strengthened. In contrast with the technical documentation gap analysis, which focuses on existing procedures concerning quality records, the QMS gap analysis identifies areas where there is no current procedural instruction for the new Quality System requirements of the MDR/IVDR. Through selection of a subset of these procedures and piloting change management activity, quantification of the resource requirements needed for documentation preparation, approval and control can be established.
- Identify the business functions required to complete the work. These resources may include the full spectrum of functions, including Quality, Regulatory, Supply Chain, R&D, Operations and others.
- Begin budget planning for 2019 and 2020 to fund the necessary additional content changes during the execution phase, based on resource and cost metrics collected during the pilots of representative products and QMS procedures.
- Continue the communication plan, broadening this to involve all functional areas and the C-suite, as well as the company’s notified bodies, to ensure that the Quality Plan is fully understood and endorsed. Understanding the notified body’s plans regarding transition efforts is critical because it will affect a company’s schedule for QMS and device certifications under the MDR.
Taking these steps results in a Quality Plan that documents overall program steps and the implementation path under the new EU MDR and IVDR. This critical element in a company’s strategy builds confidence among all stakeholders that the organization is firmly on track for compliance.
Contact us for more information on how Validant can help you successfully navigate EU MDR and IVDR compliance.
With Validant, I have the opportunity to work with pharmaceutical companies worldwide that are working to positively impact patient health. My skills from 37 years in industry in Quality System Implementation and Quality Remediation are directly applicable to help our clients.
John M. | Validant Managing Partner since 2016
Validant offers win-win solutions for clients and consultants, continually building and maintaining lasting relationships. Their experts in business development and recruiting ensure that subject matter expertise and skill set is matched for the client and the best consultants are placed on the project.
Janet W. | Validant Consultant since 2013
In the spring of 2015, my firm had a significant FDA audit with serious findings concerning sterility assurance and data integrity. We had utilized Validant for a previous engagement successfully. Before the audit concluded, I was already in contact with the Validant team for assistance. I was very impressed by how quickly they orchestrated data integrity audits at all of our 20+ other sites. We then turned to them for assistance with our third-party oversight of our manufacturing operation and quality control laboratories.