Medical devices cannot be placed on the market without conforming to safety requirements. In the U.S., the responsible regulatory agency for medical devices is the FDA’s Center for Devices and Radiological Health (CDRH). If it is a drug and device combination product, it is the CDER, Center for Drug Evaluation and Research, as well. The pathway to approval for a medical device in the U.S. is complex and depends on its device and risk classification and the level of control necessary to provide reasonable assurance of its safety and effectiveness. Under the EU’s Medical Devices Directive (MDD) and In Vitro Diagnostic Directive (IVDD), devices are put on the market following risk-based conformity assessments which typically involve a Notified Body (the organization designated by a particular EU country to assess compliance for a product before it is sold into the market) hired by the Sponsor.
The process for being approved under the MDD has historically been less rigid than that of the FDA, given the MDD presents a list of directives rather than regulations. As such, many U.S. based companies have traditionally found in the past that the path to market is easier if they obtain certification mark (CE) approval first (often in the form of self-certification), establish a customer base in Europe, then apply for FDA approval in the US thereafter once they have actual use data. This approach has usually been a lower barrier method to seeking FDA approval in the United States.
By now it’s no secret that the EU has changed the current MDD and IVDD to the new EU Medical Device Regulation (EU MDR) and In Vitro Diagnostics Regulation (IVDR), effective May 26, 2020, for the MDR and May 26, 2022, for the IVDR. These new regulations set forth by the European Parliament seek to increase medical device safety and effectiveness in the EU Market while addressing weaknesses revealed in the implementation of MDD and IVDD. The modifications brought about by the MDR will significantly affect processes pertaining to product development, manufacturing, distribution and post-market product monitoring.
While the majority of the new requirements are simply more limiting extensions to already existing directives, manufacturers that produce medical devices for the EU market today should not discount the amount of work and rigor that is required to switch from the current MDD to the new EU MDR. In fact, companies will have 123 articles and 17 annexes of dense and complex requirements to meet before the 2020 deadline. Additionally, new conditions that will need to be addressed for most legacy devices include being re-certified in accordance with the new regulations, rather than grandfathered in.
In an ideal world companies should have already formulated a comprehensive step-by-step changeover plan and be implementing it now. Implementing the MDR requires a structured approach, since the transition to new MDR CE certificates can occur over several years. The good news is that devices placed on the market before May 2020 under the MDD and even after May 2020 can remain on the market until May 2025, depending on when you received your CE certification. While you may have a bit more time, you could still find yourself behind the eight ball. Don’t panic though. Here are 5 things you should do to ensure you are on the path to success:
1. Understand the new EU MDR changes and how they apply to you.
If you market your device in the EU in accordance with MDD, understand that the new EU MDR is less focused on the pre-approval stage of medical device manufacturing, and instead, promotes a life-cycle approach to medical device regulation. In addition, there is no grandfathering of devices under the MDR and, in most cases, it is no longer possible to self-certify. Under the new regulations your device classification may have also changed and now may require clinical evaluation and revamping of the Technical File.
Notified Bodies will also play a bigger role in supervising the manufacturer’s Post Market Surveillance (PMS) system. Notified Bodies now hold liability alongside the manufacturer, which will mean more stringent oversight of acceptable clinical support and data, including unannounced inspections. Additional scrutiny comes as certain devices designated as higher risk will now require third-parties to review submissions and provide analysis prior to gaining auditor certification. Many current Notified Bodies may not be up to these new requirements and as such, OEMs may need to identify and change to a new Notified Body.
2. Perform a gap analysis and qualitative review of your existing Technical File.
A gap analysis is the first critical step 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. Depending on how many products a company markets in the EU, this work could take upwards of several months. A thorough gap analysis will include device, clinical and QMS related issues, addressing all aspects of the MDR or IVDR, and will generate a task list for updating your procedures and documentation, while setting the stage for remediation and design changes if necessary. As an example, a device classification change can warrant extra documentation requirements, additional clinical investigation, and a comprehensive risk management review, all of which a complete gap analysis will uncover.
3. Conform to the current quality management and risk standards.
Once a gap analysis has been completed, remediate any necessary changes to process to conform to the newly mandated quality management and risk standards. The new EU MDR requires a comprehensive quality management system (QMS) to be implemented. Most companies meet this requirement by obtaining ISO 13485:2016 certification and conforming to the EN ISO 14971:2012 risk management standard, although having an ISO 13485:2016 conforming QMS will not fulfill all of the new requirements specified in the EU MDR, and risk management goes beyond conforming to EN ISO 14971:2012. The regulation requires the manufacturer’s QMS to include a post-market surveillance system for each device. Newly defined responsibilities for distributors and importers related to post-market surveillance will help manufacturers better understand their device throughout its entire life cycle.
4. Create a master plan for closing the gaps.
Start by examining the entire portfolio and determine if each product’s market value justifies the cost associated with getting into compliance. For legacy products in particular, this can be a tough decision as the gap analysis may reveal a greater level of effort needed to gain compliance than for newer devices, and could be a challenge to demonstrate that they are still considered state-of-the-art without significant design change. You’ll also want to consider the impact to other device usage or collateral costs associated with the removal of a device, especially if there are multiple devices that are used simultaneously to manage or diagnose a specific condition or illness.
Identify detailed sub-projects such as technical documentation updates, clinical evaluation remediation, upgrade of your reporting systems and more. Assign the resources needed and completion dates for each task. Set up a cross-functional project team utilizing internal and external resources. You will need to work with project management, engineering, your technical writers, manufacturing, operations, legal, regulatory, quality, clinical specialists, IT, your distributors, importers, authorized representative (AR), and your Notified Body (NB), etc. This team will need to track the progress of all tasks, track gaps that occur during the master plan progress, identify risks that may transpire during implementation, etc. and hold people accountable for meeting planned dates.
5. Implement the plan.
Now it’s time to put the plan into action. It can be hard to prioritize work like this, but without it, product will no longer be marketable in the EU, so get this work on everyone’s radar. Execute all the sub-projects in the master plan and modify the master plan as needed for any unanticipated changes, gaps, and risks that may need to be addressed. Collect regular status updates from various teams working on sub-projects to the overall project management team. Ensure that any living documents are reviewed and brought into conformity with the document/process/requirements of the MDR. This could include risk management files, clinical evidence, technical documentation, etc. Additionally, you’ll want to continue to monitor the EU regulatory environment going forward as additional changes could occur.
The steps may be simple, but the full spectrum of work behind them is a challenge. As mentioned, one cannot do this alone, and with all of the variables in play, it’s important to form partnerships with others who can navigate and execute these sometimes arduous tasks. Having extensive experience in Medical Device development and working with industries that require adherence to complex conformance requirements and safety regulations, Syncroness provides the necessary solutions to transition to the new MDR for our customers who manufacture and distribute in the EU.
Don’t put it off. Contact us today to learn more about our MDR Gap Analysis and MDR Remediation solutions.