Significant changes are ahead for medical device manufacturers.
The EU’s Medical Device Regulation (EU MDR), which is set to replace the current directive for the regulation of devices in 2020, will introduce significant regulatory changes that will impact all organizations producing or supplying medical device products to Europe.
Ahead of the American Medical Device Summit 2019, Generis Group spoke with Yashesh Rawal, Regulatory Affairs Specialist from MAE Group, to discuss the major challenges of the new EU MDR, its impact on medical device manufacturers, and how organizations can prepare to ensure a smooth transition.
Is your company prepared for the new EU MDR?
As companies face a new set of stringent regulations that govern the production and distribution of medical devices in Europe, we sat down with Yashesh to discuss the impact of the new regulation, how companies can prepare for this change, and what members of the medical device industry can do to stay informed during the transition from MDD to MDR.
What are the major challenges of the new MDR?
The new European Union Medical Device Regulation (MDR) replaces the Medical Devices Directive (MDD) and will require manufacturers to make significant changes in product development, data reporting, and quality assurance. This long-awaited regulation brings with it more scrutiny of the process required to obtain a CE Marking for your product to sell your device in Europe as it includes robust requirements for medical evaluation and for post-market surveillance.
The new EU MDR began a three-year transition period in May 2017, requiring the medical device industry to move from the current Medical Devices Directive (MDD) to the new Medical Devices Regulation (EU) 2017/745 (MDR) by May 26, 2020. As this deadline is just one year away, the biggest challenge of the new regulation is the sheer workload required to implement the new regulation and the transition from MDD to MDR. As a result, all medical device manufacturers can expect higher costs and longer timelines for developing new products. With the new regulation in force, clinical monitoring and collecting evidence for clinical evaluations will also become costlier. This transition might seem overwhelming to manufacturers, and many companies do not know where to start.
For organizations who don’t know where to start, how can they prepare?
The impact of the new EU MDR is huge. It not only affects device companies but Notified Bodies and Authorized Representatives as well. Firstly, all manufacturers must communicate with their Notified Body to ensure that they will still be able to review their devices so that they can maintain their CE Mark.
From a premarket side, the focus is on the total product life cycle. The Essential Requirements Checklist has been replaced with the more comprehensive Safety and Performance Requirements. This new document will require that the manufacturer must include the method of conformity (for example, animal testing, V&V reports, etc.) and cross-reference documents. The manufacturer can no longer just point to their SOP.
The new EU MDR also brings with it major implications for labeling operations. Every device label must be updated with UDI information and all labels must include a standardized symbol when available to indicate that a package contains a medical device.
In addition, manufacturers will have to establish control over their Economic Operators, such as authorized reps, distributors, and importers. Manufacturers using an original equipment manufacturer (OEM) will need to determine how they will show that they have control over technical documentation. Needless to say, the manufacturer’s legal team will be revising agreements with these suppliers.
Finally, from a post-market perspective, there is more emphasis on surveillance and vigilance. This information will also be publicly available and companies are required to trend and report periodically by using Periodic Safety Update Reports (PSUR) that must be kept updated.
There are also plenty of changes to the clinical data requirements. Companies must evaluate their current clinical evaluation report (CER) and ensure that they are “state of the art” and align with the MEDDEV 2.7/1 Rev 4. The MDR is making it harder to use literature and equivalence to prove safety and now has more focus on powered clinical studies, especially for high-risk devices. Companies will also require a Post Market Clinical Follow-Up Plan for all devices.
These are just the tip of the iceberg. All companies should begin to evaluate and prioritize their portfolio and make sure that they are staffed with enough qualified people to handle the impactful changes the new EU MDR brings, or have contracted a well-experienced regulatory consultant like MAE Group to ensure a smooth transition through the process.
What are some of the changes between the new and old regulations?
MDR introduces a lifecycle approach to the ongoing CE Mark in compliance. Firstly, the definition of medical devices is extended to include products for cleaning, disinfection or sterilization, to include a specific group of devices that do not meet the exact definition of medical devices may have a “medical character” (eg) the MDR brings products intended without the medical purpose under its scope such as colored contact lenses and cosmetic implant devices and material.
Secondly, the number of essential requirements and the level of detail has increased. The new essential requirement checklist under the MDR has more than 220 items to review, compared to the 37 items that were on the old regulation’s checklist.
Thirdly, there is a mandatory unique device identification, UDI, which is introduced with the intention to facilitate the feasibility of devices. EUDAMED databases established under the new EU MDR will be publicly accessible and will contain comprehensive data on the devices themselves, including the Unique Device Identification (UDI); data on all economic operators; data on clinical investigations conducted in Europe; vigilance and post-market surveillance data; and data on Notified Bodies and certificates issued.
There are two additional major changes within the new MDR: One is related to post-market surveillance, and the other to clinical data and clinical evaluation. In terms of post-market surveillance, this new MDR requires manufacturers to be proactive in their efforts to systemically gather and analyze post-market data. The technical documentation under MDR must contain a post-market surveillance plan that complies with the obligations of manufacturers, the Periodic Safety Updates Report, or the post-market surveillance report.
In terms of clinical evaluations, greater emphasis is placed on clinical data. Equivalence, currently used to justify referencing to studies done with other devices, is more rigorously interpreted for clinical evaluation reports. The new regulation enforces tighter market controls on high-risk devices and applies a more rigid approach to clinical evaluations and clinical investigation of clinical trials.
Lastly, the new MDR requires Notified Bodies to now serve as enforcers of the new regulations, evaluating all medical devices. This means that Notified Bodies must conduct yearly assessments of the manufacturer’s quality management system and post-market surveillance. The scrutiny and stringency has increased with the new regulation.
Under the new MDR, all currently CE-Marked devices must be recertified in accordance with new requirements. There are no grandfathering provisions available with this new regulation.
Conclusion
In conclusion, compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace. The new regulation brings with it impactful changes that will require plenty of work, but managing the transition from MDD to MDR does not have to be challenging. MAE Group has helped companies conduct gap assessments to the MDR requirements, remediate current technical documentation to MDR, create comprehensive CER, establish robust post-market surveillance system, risk management, and more. We also offer an intensive training service to MDR, CER and IVDR requirements.
Yashesh Rawal, Regulatory Affairs Specialist from MAE Group, has over seven years’ experience in global regulatory affairs in medical devices, project management, and quality management system. Yashesh has experience in successfully securing 510(k) clearances, Technical File approvals, Health Canada approvals, Clinical Evaluation Report for Class II and III medical devices, FDA pre-submission meeting requests as well as experience in GLP and GMP requirements. His medical specialties include electrical-mechanical systems, software as a medical device, disposables, neurology, cardiovascular, gastroenterology, radiology, general, as well as plastic surgery, general surgery, orthopedics, wound management, and hematology.
Learn more at: www.maeconsultinggroup.com