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Don’t Delay – the EU’s Medical Device Regulation Takes Effect Soon
Developing medical device delivery systems requires knowing and understanding what the regulations and laws are in regions where the devices are sold—and a global market means monitoring these changes with vigilance.
Today’s largest change is happening in the European Union (EU).
The European Parliament entered into force the new Medical Device Regulation EU 2017/45 on May 26th, 2017, replacing the previous Medical Device Directives 93/42/EEC, 98/79/EC, and 90/385/EEC. The focus of this article is MDD 93/42/EEC since this is the most broadly applicable to medical devices; the other two are for specific applications (in-vitro diagnostic devices and active implantable devices).
Medical device manufacturers were provided a three-year window to implement compliance efforts before the May 26, 2020 date of application (DOA) of the MDR. Submissions are no longer being accepted for the old MDD, so all submissions for new devices and renewals for existing devices which have not already been submitted now need to comply with the MDR. Any certificates issued in accordance with the MDD prior to May 26, 2020 will remain valid until their expiration or at the latest May 27, 2024. However, some systemic elements of the MDR (notably post-market surveillance requirements) will go into effect on May 26 regardless of any existing certificates. Whether you are marketing a new device or renewing certificates for existing devices, you will need to comply with the MDR in the near future.
Companies that currently market in the European Economic Area (or have plans to in the future) must be aware of what has changed —and some changes are dramatic. To further complicate the issue, due to the size and scope of the Medical Device Regulation, the medical device industry continues to work with EU regulatory authorities, and changes to the MDR continue to be made. So, keeping current is absolutely essential.
LATEST UPDATE: Due to the COVID-19 outbreak, MDR implementation has been deferred by 1 year, until May 2021.
In order to ensure smooth functioning of the market and a high level of protection of public health and patient safety, Regulation (EU) 2020/561 was published in April 2020 to amend the MDR regarding the dates of application. However, availability and response times of notified bodies may be even more limited in these disrupted times than before the pandemic. It will be especially challenging to navigate MDR requirements in the current environment.
Why change the Medical Device Directives?
Within the EU member states, the Medical Device Directives were implemented into national law. Manufacturers of medical devices were required to comply with the Directives in order to obtain a CE mark and allow their devices to be marketed and sold in the EU.
However, the Directives date back to the 1990’s and have not kept pace with the tremendous advancements and innovations in science and technology. A series of very high-profile medical crises (breast implants and hip fractures) spotlighted the urgent need for advancement.
At the very center of the MDR is an EU commitment to protecting patient safety and enhancing transparency. And, the Medical Device Regulation’s new definition of covered devices and updated regulations take patient protection and the changes in technology into account.
Is your device affected?
If your device was previously subject to the Directives, you will now need to be compliant with the MDR for any applications starting May 26, 2021. In addition, some device classifications have changed in the MDR, so your device may be subject to a higher level of review under the MDR.
For combination products, applicability of the MDD and the MDR remain the same. Most combination products are subject to all requirements of the MDR, but at a minimum must demonstrate conformity with the MDR safety and performance requirements for the device constituent. Note that the previous MDD requirements for safety and performance, i.e., the Essential Requirements in Annex I, have been expanded in the MDR. Therefore, compliance to the MDD does not necessarily mean your device will meet the requirements of the MDR.
Key differences between MDD and MDR
Knowing what the differences are between the old governing Directives and the Medical Device Regulation can help medical device manufacturers strategize and plan the most effective ways to become compliant. The new regulation is vast— the MDR is much longer than the Directives it is replacing.
Device Classification: As noted earlier, patient safety is a guiding principle around which the regulations are built. One key change is the broadening of the number and types of devices that are covered by the MDR. With changes to the device classification rules, some devices are being reclassified to a higher risk class, such as surgical meshes and spinal implants, requiring more stringent and longer reviews as well as an increased need for clinical data. In fact, most software that was previously classified as a Class I medical device and self-certified will require Notified Body review under the MDR. (Source)
Annex I Requirements: The general safety and performance requirements (formerly known in the MDD as the Annex I Essential Requirements) have a substantially higher focus on material properties. Previous biocompatibility testing may not be accepted under the MDR, even if performed according to ISO 10993.
Risk Management has also been added to Annex I, but these mirror the requirements of ISO 14971 that most manufacturers are already following.
Clinical Data: Clinical equivalence to existing devices will be evaluated based on the new MDR requirements, not the previous MDD. If you previously relied on data for predicate devices approved per the MDD, those data may no longer be acceptable. Therefore, be sure to re-evaluate your clinical data or equivalency rationales based on the requirements of the MDR.
Post-Market Activities: In addition to technical device requirements, there are some major systemic changes in the MDR. One of area of markedly greater focus is post-market surveillance, including post-market clinical follow-up (PMCF). Many post-market activities are passive in nature but the MDR places an emphasis on proactive measures. In addition, note that medical device vigilance reporting which was previously detailed in MEDDEV 2.12-1 is now included in the MDR (the MEDDEV guidance document will become obsolete). Unlike the technical requirements which will be assessed at the time your device application is submitted, the MDR post-market requirements go into effect on May 26, 2021 regardless of the status of any device submissions. Whole new sections are dedicated to post-market surveillance and post-market clinical follow up, which are only mentioned briefly in the MDD. Post-market follow-up is an area of weakness for many companies. Be sure that you have robust documentation because you can be sure that this area will be scrutinized by your Notified Body.
UDI: The inclusion of a “Unique Device Identification” (UDI) mandate is another big change under the MDR. This will help make devices identifiable throughout the supply chain and sales region and allow for tracking of safety and clinical performance information, which will be made available to the public. While the MDR requirements for UDI are similar to the UDI requirements already implemented by FDA, they are not harmonized. There has been a commitment to align the systems, so stay tuned…
Notified Bodies: Notified Bodies must be assessed and designated to new higher standards under the Medical Device Regulation before they can conduct conformity assessments. As a result, there will be fewer Notified Bodies available to review submissions and certify products, as well as more stringent oversight of their activities. As of December 2019, only seven Notified Bodies have been designated under the MDR, and Notified Bodies previously designated under the MDD may not pursue or achieve designation under the MDR. The reduced number of available Notified Bodies is compounded with more complex review, a higher level of scrutiny, and learning to navigate a new regulation. On top of the technical challenges of meeting the new MDR requirements, it’s critical to make arrangements for your product to be reviewed by one of the few MDR-designated Notified Bodies that are serving the entire industry.
Quality Management System: On top of meeting the actual requirements, you will also need to update your QMS to incorporate all the requirements of the MDR. Depending on the complexity of your QMS, this may be more challenging and time-consuming than the actual technical documentation.
Transitioning to the new Medical Device Regulation
Medical device manufacturers need to act quickly, especially if transition activities are not already in full swing. The mandatory date of application deadline is in May 2021 — only a few months away.
Given the scope of the Medical Device Regulation and new requirements, medical device manufacturers will have to put plans in place now to be compliant by the May 2021 deadline. These plans will include quality management system (QMS) implementation or updates as well as a thorough review of their product portfolio to determine which devices are affected and how, particularly if some devices have been reclassified.
They then need to begin the process of updating or implementing new QMS processes, device documentation and labeling (including ensuring that it is available in all EU member states’ languages) and making certain that evidence necessary to demonstrate compliance is readily available.
The MDR is a new paradigm. Assuming that data submitted under the MDD will be acceptable under the MDR may lead to unpleasant surprises.
Given the significant amount of work that must be done prior to submitting devices for certification and the lower overall number of Notified Bodies available to conduct assessments and issue certifications, time is running extremely short.
Don’t delay, or you will pay.
Negative consequences for not achieving compliance by the deadline are significant and can cause many sleepless nights for companies.
Delays and backlogs are likely and should be accounted for during strategic compliance planning and portfolio management. The earlier you can submit devices for MDR certification, the better. If you haven’t engaged with a Notified Body yet (who as noted above will be significantly fewer and backlogged themselves, trying to service their growing list of clients all trying to meet the same deadline), it may be a challenge to do so and will likely lead to market delay.
Think about the number of patients that would not have access to the care they need because a device had to be withdrawn from the market due to the device’s new status under the MDR. Some companies have already made the decision to exit the EU market. Think about missing a product launch date because of unanticipated approval submission requirements. Occurrences like these could lead to serious financial and reputational setbacks and a potential loss of market share.
The greatest risk to medical device manufacturers, however, is the potential for negative impacts to patients. If a product is withdrawn from market, it is the patients who would suffer most. The need to scramble to find an approved alternative, the loss of trust that takes time to establish, and potential for medical setbacks caused by the disruption—all of this would do irreparable damage to the relationship between patients and a medical device manufacturer.
If there’s one message that medical device manufacturers need to fully embrace, it is that the time to comply is now.
Medical device manufacturers have a large amount of effort ahead of them to comply with the MDR and a short window to complete necessary tasks. This already-short timeline is compressed by the reality that fewer Notified Bodies will complete the process of obtaining designation under the MDR, which in turn may slow down the CE marking process. The good news is that if you need assistance with this effort, it is available.
The experienced specialists at Suttons Creek can assess your readiness. Give us a call or contact us here, and we’ll provide a free virtual consultation.
Jeff Kim, Suttons Creek Consultant – Jeff Kim has over 20 years of experience in the Medical Device industry ranging from Fortune 100 companies to early startups. His career has spanned product development, project management, and quality at the senior management level. He has extensive technical experience with all stages of the product development cycle as well as an in-depth knowledge of quality systems. He has led multiple FDA and ISO inspections. Since joining Suttons Creek, Jeff has leveraged his expertise with multiple clients in the combination product space.
LinkedIn – Jeff Kim