Author: Suzanne Broussard
The passing of the delay for the Medical Device Regulation (MDR) date of application to May 26, 2021 was welcoming news for many device manufacturers. However, the delay now has manufacturers close to MDR submission questioning what the best course of action is now that they have a choice. Should they continue to push for certification under MDR 2017/745, or should they backtrack to Medical Device Directive (MDD) certification?
The amended regulation to extend the MDR date of application by 1 year was needed due to the immense burden placed on the healthcare industry by the global COVID-19 pandemic. The pandemic immediately increased demand for personnel protective gear, such as medical gloves, surgical masks, and the equipment required to treat patients infected with COVID-19. The extension for the MDR date of application was implemented to prevent shortages of the needed medical devices that were previously certified under the MDD or Active Implantable Medical Device Directive (AIMDD) but have not yet obtained certification under MDR.
In addition to the direct burden on the healthcare industry, the pandemic significantly impacted the medtech industry by significantly restricting the ability of medical device manufacturers to meet the original May 26th, 2020 deadline due to social distancing and travel restrictions. Once this became evident, the European Commission and Member States acted quickly to pass the amended regulation that pushed the date of application for MDR to 26 May 2021 and allows MDD and AIMDD to apply until this date.
Overall, the consensus indicates that companies that that are able to comply with MDR should do so as fast as possible as discussed in more detail later in this piece.
Medical device manufacturers need to quickly determine their need for audits and clinical trials as major considerations when making the decision on how to move forward.
Audits by regulatory notified bodes are required for manufacturer that have not yet obtained MDR certification, and experts think there are many unknows for those with an MDR submission waiting for an audit. However, the legality of performing virtual audits is taking center stage. Manufacturers need to consider the following based on information as of July 2020:
Physical Audits or Virtual Audits:
- Physical audits are currently not possible due to the COVID-19 pandemic
- Virtual audits are allowed by the European Commission for some devices currently under the MDD, AIMDD, and In Vitro Device Directive (IVD), such as annual surveillance audits, recertification audits, or when change certification is needed or manufacturers must change notified bodies
- Virtual audits for MDD, AIMDD, and IVD are not authorized for the following:
- Initial certification audits
- Unannounced audits
- Special audits that require on-site assessment (i.e., verification of the implementation of specific corrective actions, extend the scope of certification, etc.)
- Virtual audits are allowed for notified body renewal designations
- Physical audits are required for MDR initial certifications
- Virtual audits may be allowed for products already MDR certified
- For MDR, the virtual guidelines “may also apply to audits” if “the availability of devices is affected by COVID-19 restrictions.” It is unclear exactly what this means for manufacturers trying to obtain MDR certification. It appears as if the European Commission will not revise its rules anytime soon to allow for MDR remote audits under normal circumstances. Concessions maybe made on a case-by-case basis for devices considered “relevant to ensure medical care, especially if clinically necessary during the period of COVIC-19 restrictions.
The current stance of physical audits for manufactures that are currently going through the MDR application or are in the process of submission are the most affected. Products ready to be audited against MDR may not be able to proceed. The industry is stressing the importance of virtual audits for MDR submissions, at least on an interim basis, as the requirement for physical audits will prevent MDR certifications requiring manufactures to rely on the directives. Manufacturers forced to reverse course and prepare for MDD or AIMDD will end up spending vast resources reworking technical documents to meet directives that could be better spend moving forward with the new regulation.
Many believe that failure to allow virtual audits for MDR certification is penalizing the very manufacturers that hustled to meet the deadlines set out by the European Commission. This situation impacts manufacturers that have submitted the MDR and awaiting an audit.
New medical device products may be stalled for the foreseeable future since notified bodies had already shifted gears to only audit new products under the new regulations.
The potential implementation of new technologies like drones and google glasses along with webcam virtual tours are seen as ways to maintain the current high standards of audits. And, the use of these technologies can be modified to improve the task based on the vast experience obtained from the directives virtual audits.
The number of notified bodies that are available to perform MDD audits is also of concern. Most notified bodies had shifted their focus to auditing MDR. A sift in manufactures focus from obtaining certification under MDR will also create a bigger bottleneck in 2024 when all devices must comply with MDR.
A recent publication in Nature Reviews: Drug Discovery highlights the challenges of drug development during a pandemic.1 A survey of 36 investigators that conduce clinical trials focused on cancer from around the world conducted by the Cancer Research Institute (CRI) and IQVIA indicates that the COVID-19 pandemic dramatically impacted clinical research. In the United States and Europe, on 14-20% of institutions are continuing to enroll patients at the usual rate. Those institutions that were continuing had lower enrollment rates and patient care was a key factor. The progress of clinical trials critical for all phases of regulatory compliance.
The challenges of obtaining safety and performance data will certainly affect all aspects of medical device compliance.
The decisions going forward is not easy choice and should be made based on where the company is in the process of preparing for MDR.
Several high-profile organizations are weighing in on the dilemma.
MedTech Insights recently hosted a panel discussion with 3 renowned experts on the regulations of medical devices in the European Union: Bassil Akra of QUNIQUE consultancy (formally of TÜV-SÜD notified body), Gert Bos of Qserve consultancy, and Erik Vollebregt of Axon Lawyers. These experts agree that those that are in a position to move forward with MDR application should do so.2 They also stressed that “A year is not an extra year”.
MedTech Europe, an industry association, suggest that manufacturers that are not planning on MDR submission should consider using the MDD standards for now.3 MedTech went so far as to rank what it sees as the best 3 options according to perceived value:
- State-of-the-art versions of standards that are harmonized under the current directives.
- Other published standards identified as candidates for harmonization under the new regulations; or
- Appropriate international and European consensus standards (ISO/IEC or EN), given that harmonized standards have mostly originated for them.
MedTech Europe also indicated that manufacturers may need to use multiple standards to demonstrate state-of-the-art performance based on the specific requirements for each device.
For those manufactures moving forward with preparing for the submission of MDR, the extra year to prepare provides some breathing room. Here are a number of areas that have increase requirements that manufactures can focus on to meet the significant challenges of MDR compliance.
- Quality management system
- Supply chain – new obligations
- Technical files – gaps, additional clinical data
- Post-market surveillance and vigilance systems
The decision to move forward with either an MDR submission or shifting to obtain an early MDD certification and take advantage of the grace period until 2024 for MDR compliance is a big one for device manufacturers. It is critical to work with your notified body and regulatory experts to determine what path is right for you.
Either way, Criterion Edge is prepared to provide expert medical writers to facilitate a timely submission.