EDITOR’S NOTE: This the second part of a two-part blog series about the EU MDR and the challenges the medical device industry faces in coming into compliance with regulation. Read Part 1 of this blog series here.
In a publicly available podcast earlier this year, Qserve’s Gert Bos gave an overview of some of the issues facing medical device manufacturers in complying with the Medical Device Regulation (MDR) in conjunction with an example roadmap companies can use to transition to the new requirements.Bos posed two questions that he suggested device manufacturers ask themselves early on in the process of investigating the impact of the MDR:
• Do you know what percentage of your revenue is based on your European Union (EU) market approval?
• What will happen to your company if you lose that market share?
Additional questions device manufacturers should consider were submitted to Xavier Health from Munich, Germany-based Notified Body TÜV SÜD Product Service Vice President Bassil Akra:
• Will your product portfolio remain the same after full implementation of the MDR?
• Did you put sufficient budget in place to ensure hiring, training and development of new resources?
• Are you willing to spend millions to fulfill clinical data requirements on well-established technologies or legacy devices?
• Is your Notified Body still allowed to deliver the same level of services after May 2020?
• Do you need to change your Notified Body due to loss or limited designation?
• Are you working with a U.K. Notified Body or have a U.K. Authorized Representative that needs to be changed after Brexit?
Comparing the MDR to the MDD it replaced, “The number of articles and pages have increased six-fold, including a steep increase in detail and specifications,” Bos pointed out. The MDD included 20 articles in 60 pages, and 12 annexes. The MDR contains 123 articles in 360 pages, and 17 annexes.
According to Bos, a “typical” MDR transition program takes 30 months. The EU transition window now has 19 months left. He used a graphic to show the eight steps he recommends manufacturers follow to prepare for EU MDR compliance (see figure below).
He explained that the early steps include creating a project to develop a scope, followed by gap assessments “that will be essential early on, because it takes a lot of detail to bridge the six-fold increase of legal text in the law. Not only is the text changing, but also the existing wording and concepts are rapidly shifting.”
Bos described the portfolio and global impact assessments as “essential” since there is no grandfathering and only limited allowance on short-term continuation of suppliers to the EU market. “Following the formal transition, many companies will choose to remove some of their legacy product portfolio,” he said.
Once key decisions have been made, “the path forward to train staff and to implement the changes are the logical next steps. In the end, some level of self-reflection is needed, and some fine tuning before the first compliance conformity assessments against the new requirements.”
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At the start of your EU MDR project, it will be essential to understand the scope of the project you are engaging in and to plan accordingly. An initial budget will be needed to set up a project team and to start assessing the environment, the task at hand, and to engage in the first steps of the gap assessment.
“Once your team sees some of the details, it will not be immediately impressed with the sense of urgency that it should be experiencing. At first glance, the new MDR does not seem overwhelmingly different,” Bos said.
The premarket reviews are still done by the same Notified Bodies, “the ones you have known and have a good relationship with,” Bos noted. “It is only when you engage and go more into depth that you see where the key issues are, the key problems, and some of the things that you urgently need to start in order to have sufficient time to complete the project.”
He advised looking closely at the 45 pages of instructions in the EU MDR addressed to the Notified Bodies to help companies understand what the bodies will be looking for.
Bos listed the following as key areas to pay attention to and to take into account when scoping an MDR transition project:
• Which products are included and excluded
• More specific clinical data needed to support the performance and safety of the individual medical devices with their intended use and with the formal claims you wish to bring to the market
• Limited reliance on equivalence and more on direct clinical data
• The new concepts of regulatory life cycle management
• The requirement to find sufficient clinical data, even on lower risk products and older existing products on the market
• Requirements for upstream and downstream supply chains
• Liability for the importer’s authorized representatives and sponsors of clinical trials
• The number of product categories where authorities in the EU are supporting the Notified Bodies and the manufacturers with position papers and with formal consultations and conformity assessments
Bos recommended that “a good approach would be to not use the full time that Notified Bodies allow you to get into compliance, as the assessment on the availability of clinical data is one of the key elements in your gap assessment needed at the start of your MDR project.”
The first steps in a gap assessment should include determining whether your products are covered by the MDR, Bos said. “Are there products covered that are not currently marketed under the MDD? There have been classification changes.” He noted that clinical data are “crucial” in making an assessment on whether individual products can be marketed under the MDR.
“Having an assessment completed is important to build commitment from the Notified Body that you work with,” Bos maintained. “These include rationales used on product classification and inclusion or exclusion of clinical study requirements, including postmarket clinical data.”
He recommended that a core team be provided with provide gap assessment tools and oversight to ensure the gap assessment covers all of the documentation in the dossiers with sufficient focus on the availability of acceptable clinical data.
When assessing a product portfolio, Bos recommended looking at the availability of sufficient clinical data to support each clinical indication as well as at supply chain partners. “If they are not sufficiently available or if they do not wish to cooperate with the enhanced transparency, changes in suppliers and subcontractors may be needed. Those changes take time and energy.”
A key question will be whether all products stay in the company’s scope or if it should consider selling off legacy products.
Bos suggested that each company “paint a picture of your company now and in the future around the new requirements and supervision in Europe. One thing is clear: Not acting is not an option.”
As part of the global impact analysis phase of the roadmap, Bos recommended considering “all the various change notifications, the time they will take, and what your strategy will be. Remember that you cannot just look at Europe independently. The changes needed are entwined with your global registration policy.” These become part of the master compliance roadmap.
“When implementing the roadmap, the Notified Body will remain a crucial partner, even more so in the future,” Bos emphasized. “You will need to engage with them to learn about their plans to be prepared to file for the MDR designation. Where are they going? What timelines do they see for their designation? What are they doing to enhance the availability of their resources? Make sure they are aware of your compliance improvement plans to move into the MDR thinking and philosophy.”
The final phases are creating and conducting internal training on the EU MDR and its impact, and performing effectiveness checks prior to the Notified Body assessments of your company’s compliance to the EU MDR.
“This will be an effort on a continuous basis,” Bos emphasized. “The EU MDR takes the view that continuous improvement, monitoring the safety of products on the market, and design improvements will be essential.”
The dialogue continues at the Xavier EU MDR Workshop March 27-28, 2019. In this advanced workshop, experts Bassil Akra (TÜV SÜD), Philippe Auclair (Abbott), Gert Bos (Qserve), and Kim Trautman (NSF International) will lead you through the development of a time-critical action plan for keeping your medical devices on the EU market using proven strategies and tactics.
Jerry Chapman is a GMP consultant with nearly 40 years of experience in the pharmaceutical industry, with technical and leadership positions in product development, manufacturing, plant quality, site quality, corporate quality and quality systems. He designed and implemented a comprehensive “GMP Intelligence” process at Eli Lilly and again as a consultant at a top‐five animal health firm in 2017. Chapman served as senior editor at International Pharmaceutical Quality (IPQ) for six years, where he stayed current with U.S. and international GMP and CMC topics, and reported extensively on them. He now consults on GMP intelligence, quality knowledge management, the development and implementation of GMP training and other GMP topics. He is also a freelance writer. Visit Chapman's website here to learn more about Jerry and what he has to offer. His email is email@example.com.
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