As we transition towards the dates when the new European Union device regulations apply – May 26, 2020, for the Medical Devices Regulation (MDR) and May 26, 2022, for the In Vitro Diagnostic Medical Device Regulation (IVDR) (Figure 1); – many device manufacturers are seeking guidance on how best to prepare.
As mentioned in our recent blog, a key first step is to conduct a thorough gap analysis to evaluate current capabilities and future requirements. This analysis should cover existing products, as well as those in development, estimating the costs and resources required to meet the requirements of the MDR or IVDR. The results can help predict how the changes will impact profitability and inform a company’s decisions on its device portfolio. These tasks are time consuming, making early action essential. Our advice is to start the assessment based on what is known today, and to add to this as more information becomes available.
Figure 1: A timeline for MDR and IVDR implementation
A key step is to identify which risk class each device fits into (Figure 2). Next, companies will need to find out what additional data will be needed, such as further clinical testing, and changes to technical documentation, labeling, quality assurance or manufacturing processes. A route to compliance can then be determined, offering potential for valuable market differentiation.
Figure 2: Risk classes for medical devices under EU legislation
While many companies view changes in regulations as purely a Regulatory or Quality issue, an ideal gap assessment team should in fact be cross-functional, with members from all parts of the business. For example, several of the new device requirements affect Supply Chain (Unique Device Identification, Economic Operator definitions and responsibilities), Operations (suppliers, subcontractors and continuous monitoring to be represented in the technical documentation), Clinical Affairs (clinical evaluation reports and performance evaluation reports), and Commercial (promotional material claims). Engineers should also be included to assess any gaps in the definitions and verification of key performance requirements. Manufacturing experts can help ensure that key manufacturing processes and raw material testing methods have been appropriately validated using robust sample sizes.
In addition to examining new aspects of the MDR or IVDR, the gap assessment should evaluate compliance with existing requirements that will be assessed more strictly in the new regulatory environment. In one example, ‘state of the art’, conformance to current standards, will be assessed with heightened rigor. Benchmarks that may have been acceptable in the past may require improvement to comply with the new regulations.
Focus on Process Integration
It is important to assess individual process compliance, and to look carefully for the integration of processes in the quality management system. For example, it will not be sufficient simply to state that ‘the risk management file (RMF) is compliant with ISO 14971:2012.’ The new regulations require clear integration of a risk management system where feedback loops are evident and functional (Annex I GSPR 3) as a ‘continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating…’. Establishing a robust process for evaluation of the benefit-risk profile for your devices will be key.
IT systems should also be included in the gap assessment, to ensure that they are capable of performing in the new regulatory environment. Employee skills are another essential element in successfully executing to the new requirements, and these should be carefully evaluated and updated as needed.
A new conformity baseline needs to be established. The new regulations aim to ensure ‘a high level of safety and health whilst supporting innovation,’ so any gaps should be identified, and conformance clearly demonstrated.
In conclusion, the gap assessment is a vital step in ensuring compliance with the new EU device regulations. If not already underway, this step should be initiated without delay. The assessment should be carefully documented, with actionable recommendations, to form the basis of a Quality Plan. This will be the topic of the next blog in this series.
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.