Nicolle Cannon, Founder and CEO, Cannon Quality Group LLC02.08.21
The COVID-19 pandemic clearly dropped a wrench in the gears of many industries as well as the normal routines of people across the globe. Through most of 2020, organizations scrambled to revise business strategies and processes to remain operational—and six feet apart—during the unique circumstances. It was a pivotal year for medical device companies that were busily preparing for the Medical Device Regulation (MDR)/In Vitro Device Regulation (IVDR), which was fast approaching. Then, in an 11th-hour decision, the industry received a welcome respite when the deadline was pushed out to May 26, 2021.
Medical device manufacturers no doubt enjoyed having a breather to focus on more pressing issues. Stalled clinical trials, disrupted supply chains, and halted manufacturing lines have been common scenarios due to the pandemic. Nevertheless, several months of the moratorium have passed, and now, the task of preparing for the European Union’s (EU) regulatory upgrade is back on their plates.
Restarting an already arduous project mid-stream can be daunting. Still, the clock is ticking again, and it’s time to dust off transition plans and get moving. To get the MDR/IVDR preparation ball rolling again, following are four processes to help refocus on achieving compliance with the updated MDR/IVDR Regulations.
#1: Communicate
What has changed? What changes are considered significant?
Open channels of communication with your peers and colleagues—they are your allies. Over the course of the delay, changes most likely occurred in some aspects of your product or organization. In your conversations, identify what has changed and determine what the significant changes are that need to be readdressed in the plan. The more you can create some dialog around what significant change means, the better the whole organization will be at making the changes together.
Some questions to bring up might include:
For instance, some changes considered significant are outlined in the Medical Device Coordination Group Document (MDCG) 2020-3 under Article 120(3). It’s a good idea to download and study this document. Also, consult with your Notified Body about the guidance because the agency’s opinion may differ from yours.
Other changes that can impact strategy are outlined in the IAF Mandatory Documents (IAF MD) 9:2017, Section 9.6, which include:
#2: Revisit Your Transition Plan
What is still applicable? What needs updating?
If you had a plan in place prior to the delay, putting it back into action doesn’t need to be overwhelming. In addition to communication and identifying changes, it’s important to get reacquainted with the MDR/IVDR transition timelines:
#3: Start Piloting
“The way to get started is to quit talking and begin doing.” — Walt Disney
Starting the transition process is challenging—especially when there still might be questions and uncertainties about the new regulations that were unresolved before the pandemic. One approach to make the tasks less overwhelming is to start blocking time to work on your plan. Look ahead a week, two weeks, or a month. However full your calendar is, block off some time for MDR/IVDR transition preparation.
The following starting points can help decide how much time to plan for:
Gain insight from a variety of resources.
In the past, I would say call notified bodies and stay in communication with them—but not right now. The best thing to do is get on their blogs, track their website, follow their webinars. If they’re having courses, meetings, or learning sessions, go to those sources to get as much important information as possible until it’s appropriate to start conversing with your Notified Body.
Notified Bodies are most likely all doing something different, setting different boundaries, and establishing different transition requirements. Regardless of what the regulations say, Notified Bodies are functioning based on their own processes, limitations, and resources.
Other useful resources to follow include:
Conclusion
To get back up to speed with MDR/IVDR preparations, work through these four tasks multiple times. I don’t recommend you outsource these tasks, even if your team is overloaded. I think it’s important your team understands the processes and are trained and comfortable with them. Until your team is at that point, it doesn’t make sense to outsource these transition activities.
Given the amount of work that needs to be done in a short amount of time, as well as the extent of changes with the new regulations, Notified Bodies will want your processes to be laid out in a way that is easy for them to follow. They need companies to fully understand their own products, processes, and transition situation and to be able to clearly communicate them. Most importantly, stay informed, revisit your plan frequently, continue to evolve your perception of the transition, and keep moving forward.
Nicolle Cannon is the founder and CEO of Cannon Quality Group LLC, a full-service, outsourced quality management organization, specializing in supporting startups and early-stage medical device companies. Cannon Quality Group has been serving clients for more than 10 years. Prior to starting a consulting business, Cannon worked in quality for various medical device companies, including FoxHollow Technologies, Advanced Stent Technologies, and AVE/Medtronic. She holds a bachelor of science degree in mechanical engineering from Cal Poly State University.
Medical device manufacturers no doubt enjoyed having a breather to focus on more pressing issues. Stalled clinical trials, disrupted supply chains, and halted manufacturing lines have been common scenarios due to the pandemic. Nevertheless, several months of the moratorium have passed, and now, the task of preparing for the European Union’s (EU) regulatory upgrade is back on their plates.
Restarting an already arduous project mid-stream can be daunting. Still, the clock is ticking again, and it’s time to dust off transition plans and get moving. To get the MDR/IVDR preparation ball rolling again, following are four processes to help refocus on achieving compliance with the updated MDR/IVDR Regulations.
#1: Communicate
What has changed? What changes are considered significant?
Open channels of communication with your peers and colleagues—they are your allies. Over the course of the delay, changes most likely occurred in some aspects of your product or organization. In your conversations, identify what has changed and determine what the significant changes are that need to be readdressed in the plan. The more you can create some dialog around what significant change means, the better the whole organization will be at making the changes together.
Some questions to bring up might include:
- Are the business and product strategies still applicable, or have they changed in a way that will impact compliance with MDR/IVDR?
- Are the distributors and economic operators you were planning to work with in Europe still available? What is their transition status, and what are their plans for the future?
- There are emergency use authorization (EUA) plans in the U.S. that a lot of medtech companies pivoted to support. Will those be launched in Europe as well?
For instance, some changes considered significant are outlined in the Medical Device Coordination Group Document (MDCG) 2020-3 under Article 120(3). It’s a good idea to download and study this document. Also, consult with your Notified Body about the guidance because the agency’s opinion may differ from yours.
Other changes that can impact strategy are outlined in the IAF Mandatory Documents (IAF MD) 9:2017, Section 9.6, which include:
- A change in company ownership
- Extension to manufacturing and/or design control—which now includes figuring out how to make room for social distancing
- Modification of the site operation involved in the manufacturing activity, such as relocation of the manufacturing operation to a new site or centralizing the design and/or development functions for several manufacturing sites
- Modifications to special processes, such as a change in production from sterilization through a supplier to an on-site facility, or a change in the sterilization method
- Change in the defined authority of the management representative that impacts the quality management system effectiveness, regulatory compliance, or the capability and authority to ensure only safe and effective medical devices are released
#2: Revisit Your Transition Plan
What is still applicable? What needs updating?
If you had a plan in place prior to the delay, putting it back into action doesn’t need to be overwhelming. In addition to communication and identifying changes, it’s important to get reacquainted with the MDR/IVDR transition timelines:
- May 26, 2021: The new deadline for compliance with MDR. Legacy devices must have an up-to-date MDR/IVDR CE mark from a qualified Notified Body to stay on the market. Manufacturers of medical devices cannot apply for MDR/IVDR re-certification of these products after this deadline.
- May 2022: The deadline for compliance to IVDR. The timeline for IVDR did not change. The only shift was MDR. This results in a one-year difference between MDR and IVDR. Now that these dates are closer together, it will put more strain on the already overworked Notified Bodies. The pandemic put more stress on them just like it did on companies. That being the case, in-vitro device developers should begin preparing for the May 26, 2022, deadline by observing the efforts of companies that have transitioned to MDR or are still transitioning.
- May 26, 2024: The end of the grace period extended to specified products with a valid certificate issued under the Medical Device Directive (MDD) prior to May 2021.
- May 27, 2025: The end of availability or putting into service devices covered by MDD and Active Implantable Medical Devices Directive (AIMDD) certificates.
#3: Start Piloting
“The way to get started is to quit talking and begin doing.” — Walt Disney
Starting the transition process is challenging—especially when there still might be questions and uncertainties about the new regulations that were unresolved before the pandemic. One approach to make the tasks less overwhelming is to start blocking time to work on your plan. Look ahead a week, two weeks, or a month. However full your calendar is, block off some time for MDR/IVDR transition preparation.
The following starting points can help decide how much time to plan for:
- Start with products highest in revenue or are 80 percent likely not to change.
- Start with what will be due on the May 2021 deadline.
- Create a list of the items most volatile to change. Set this list aside to address at a later time when you’ve made some decisions and are more certain about the changes you will implement.
- Start laying the groundwork for new products. Talk with your development teams, and identify the new pieces they should be integrating right now that will be necessary for complying with the new regulations.
Gain insight from a variety of resources.
In the past, I would say call notified bodies and stay in communication with them—but not right now. The best thing to do is get on their blogs, track their website, follow their webinars. If they’re having courses, meetings, or learning sessions, go to those sources to get as much important information as possible until it’s appropriate to start conversing with your Notified Body.
Notified Bodies are most likely all doing something different, setting different boundaries, and establishing different transition requirements. Regardless of what the regulations say, Notified Bodies are functioning based on their own processes, limitations, and resources.
Other useful resources to follow include:
- The Competent Authorities for Medical Devices (CAMD) Implementation Task Force: Review its timeline and see how the organization is progressing with the timeline. Also, determine where the organization is with implementing its rolling plan.
- European Commission (EC): The organization frequently releases common specifications. For instance, last October, it released the common specification for infusion pumps.
Conclusion
To get back up to speed with MDR/IVDR preparations, work through these four tasks multiple times. I don’t recommend you outsource these tasks, even if your team is overloaded. I think it’s important your team understands the processes and are trained and comfortable with them. Until your team is at that point, it doesn’t make sense to outsource these transition activities.
Given the amount of work that needs to be done in a short amount of time, as well as the extent of changes with the new regulations, Notified Bodies will want your processes to be laid out in a way that is easy for them to follow. They need companies to fully understand their own products, processes, and transition situation and to be able to clearly communicate them. Most importantly, stay informed, revisit your plan frequently, continue to evolve your perception of the transition, and keep moving forward.
Nicolle Cannon is the founder and CEO of Cannon Quality Group LLC, a full-service, outsourced quality management organization, specializing in supporting startups and early-stage medical device companies. Cannon Quality Group has been serving clients for more than 10 years. Prior to starting a consulting business, Cannon worked in quality for various medical device companies, including FoxHollow Technologies, Advanced Stent Technologies, and AVE/Medtronic. She holds a bachelor of science degree in mechanical engineering from Cal Poly State University.
