This article describes efforts to prepare Cook Medical and its partners for full implementation of European Union Medical Device Regulations in (EU-MDR) in 2020. It is based on interviews with Cook executives Jennifer Kerr, president of Cook Research Incorporated (CRI), April Lavender, senior vice president of regulatory affairs for Cook Medical, and Sinead Quaid, director, global regulatory affairs, at Cook Ireland.
With the European Parliament's final approval of the Medical Device Regulations (EU-MDR), the new regulations entered into force in late May 2017. After a transitional period of three years for medical devices, the full implementation of EU-MDR is expected in 2020. In anticipation of full implementation, leadership at Cook Medical, a family-owned manufacturer of medical devices, has undertaken an "all hands-on deck" and practical approach to preparing for 2020.
Cook has been actively involved in the development of this new regulation for the past eight years. During this period, Cook has advocated for the CE mark system's being maintained, supported greater oversight of the Notified Body system and has urged that future regulation needs to have the clarity for allowing it to be implemented uniformly across the EU and in each member state. The final published text appears to have achieved these goals, says Jennifer Kerr, president of Cook Research Incorporated (CRI).
Kerr is involved with many aspects of the identification, development, testing, and regulatory approval of innovative medical products. Kerr's primary responsibilities include oversight of product development, testing, clinical studies, medical/scientific writing, and regulatory submissions for devices, pharmaceuticals and cell-based therapies. She also oversees and directs the alignment between CRI and the needs of the Cook divisions and other Cook entities and works to assure customer expectations are met. In total, she is responsible for scientific and clinical leadership and manages resources required to coordinate those overall functions of the company.
"We have had a seat at the table and watched this regulation develop and come to fruition, so we completely understand how this will impact our companies," she explains. We congratulate all those involved in the EU process in getting this regulation over the line."
In her role, Kerr, along with staff, offer advice for Cook Medical's device manufacturing locations who currently have medical devices in the European market or hope to have medical devices in that market in the new environment created by EU-MDR. Preparing for changes under the implementation of EU-MDR has been a big job, says Kerr. According to Kerr, because CRI is a research-based organization, Clinical Evidence (CE) is one of their primary inputs to the safety and performance data for a medical device. As EU-MDR places more emphasis during the approval reviews on the type of clinical evidence available for a medical device, Cook works to focus on new evaluations and documentation for its clinical data. She also reports that CRI is using internal and external experts to help with interpreting the new MDR requirements that apply to clinical evidence.
Many questions remain, however.
"There are questions regarding new CE expectations," explains Kerr. "Also, there are questions regarding the expectations of Notified Bodies and what feedback we can expect from them. We want to understand what our best practices should be based on and what we may have to change."
Her responsibilities have required her efforts to be increasingly directed toward helping Cook partners cope with the arrival of EU-MDR. Staying on top of the 'changes to the changes' has been a challenge, she admits.
"This effort will not conclude at the end of the 2020 timeline," predicts Kerr. "This is the new normal, and will continue as there will be new responsibilities for regulatory teams in Europe. We are trying to understand the impact as we work toward full implementation and are working closely with the Notified Bodies regarding the new MDR criteria because we have products that will need re-registration."
What will the future bring? Kerr wonders how EU-MDR may eventually impact some "downstream" business decisions facing manufacturers who want to keep their products in Europe or develop new ones for the European market.
"Some business leaders may decide that it may not be worth the effort to re-register existing technologies or develop new ones," projects Kerr. "Some business leaders may say that they are unable to pursue technologies given these requirements. Manufacturers may not see great impacts on business decisions right away, but in a few years, or maybe five or ten years, we will see impacts."
Kerr is quick to point out that a business decision to not re-register a product under the new, stiffer clinical evidence requirements doesn't mean that manufacturers have not been doing surveillance. Going 'above and beyond' to meet new requirements to keep a product in the market may not be cost-effective.
Regardless of the unpredictable future of EU-MDR's impact, Kerr's view from CRI, located in West Lafayette, Indiana is clear. "If you haven't started breaking down MDR, you are behind!" she says.
Keeping the CE Mark
April Lavender, senior vice president of regulatory affairs for Cook Medical, and a 40-year veteran of the organization with extensive experience in the company's medical device global regulatory affairs operations, also describes Cook's broadly-scoped efforts to communicate with its partners and functional units to develop best practices for EU-MDR compliance. Much effort is focused on the manufacturers to maintain their current approvals for their manufactured medical devices, says Lavender.
"Cook is a global organization with many manufacturing and operations centers," explains Lavender. "Each location has a regulatory department that manages under regional regulations. To establish best practices under MDR, we have 10 working teams with representatives from each local system.
We support and welcome the new regulation and we are investing a lot of leadership and time to understand the impact of the new regulations."
Since the genesis of EU-MDR, Lavender has coordinated with Cook's global project manager, who has oversight responsibilities for working through the impending changes to establish best practices for MDR compliance. Their aim, she says, is to help maintain compliance with requirements, to keep products commercialized by maintaining their "CE" mark in the new regulatory setting, and to coordinate all necessary communications with Notified Bodies and Competent Authorities.
"Many countries rely on the CE mark and it is important to maintain the approval for these products," explains Lavender.
Lavender points out that major healthcare markets in some of the world's developed economies, such as the US, Canada, Australia, EU, Japan and Brazil, among others under the International Medical Device Regulators Forum (IMDRF) umbrella, are evaluating whether more global requirements for premarket clearances and approvals can be adopted so companies do not have to repeat testing efforts regarding clinical and non-clinical evidence. Time and costs certainly are issues, says Lavender, as is ongoing access to medical technology for patient care.
"The creation of any new regulation is a difficult task, and the one thing that we have learned in our history is that stakeholder involvement is a critical component of this process," she suggests. "Recognized standards for safety exist and there is appropriate scientific knowledge regarding how to minimize risk. New, breakthrough medical devices may take three to five years to reach the market and it would be more cost-effective and save time to not have to do repetitive work to answer a question that already has an answer. Anything we can do to ensure that this redundancy is eliminated can only benefit the patients that we want to help."
She adds that many are concerned and trying to look ahead to determine what impact the UK's withdrawal from the European Market, popularly called "Brexit," may have in terms of regulations. Might manufacturers wanting to do business in the UK have to satisfy two sets of regulations? One set of regulations from the EU and another set for compliance in the UK?
175 pages, Uncertainties and Contradictions
According to Sinead Quaid, director, global regulatory affairs at Cook Ireland, Brexit may lead to additional requirements having to be met, but the full impact will not be clear until Brexit negotiations have been completed.
"Currently there are many scenarios which could occur," says Quaid. "First, the UK will stay within the single market and there will be no impact. Second, the UK leaves the single market and regulators will recognize the CE mark and a registration would take place similar to other countries. Third, the UK may introduce their own regulatory requirements and all devices will have to be registered under those regulations as well. But for now, it is 'wait and see' situation."
Quaid has responsibility for developing working teams across Cook companies now investigating and preparing for the coming changes.
"Because I am Cook's global project manager for the consistent implementation of the MDR across Cook Medical, I have had to become very familiar with the regulations and have a high understanding of the regulations and changes" says Quaid. "We have set up 10 global, cross functional teams to look at all aspects of the regulation."
Her job, she explains, is to work with teams, visit the manufacturers, and help everyone to have a full understanding of the regulatory changes and the timelines associated with them. The new regulations comprise about 175 pages and understanding how the regulations are written, what they say, and how they are interpreted is job number one.
Quaid says that all acknowledge there are areas needing to be addressed within the secondary legislative process. Until that process is concluded, areas of uncertainty will remain. For example, there is some 'guidance required' regarding the timelines for Unique Device Identification (UDI), the format of the implant card, and what needs to be on it, and specifically if it is enough that it would be available online for patients.
"How the area of common specifications evolves is one which we as a company will support and watch with great interest, including the additional legislation needed for many of the aspects of the regulation including restrictive substances, clinical and the UDI code," explains Quaid. The UDI identifies a device in two ways - by product, model and manufacturer and also by the production serial number and batch number. The new regulations also provide reinforcement for the rules regarding clinical evaluation (which includes performance evaluation) and clinical investigation that introduces a coordinated assessment of clinical investigation conducted in more than one EU member state."
The European Databank on Medical Devices (EUDAMED), which is the central European database used in collecting information about medical devices, will be expanded under EU-MDR to include not only UDI registration requirements, but also registration of other information, including medical device post-market follow-up, safety and clinical information, manufacturer's registration and others.
According to Quaid, the EUDAMED database must be ready in time to accept all the reports necessary.
How each company's designated person for regulatory compliance will work is something that is an uncertainty, and if that work is truly simlar to that of a Quality Person (QP), is unclear, Quaid notes. She adds that the regulations state that someone needs to "sign off" on all batches of medical devices.
"That is workable for 'pharma,' but that is not realistic in the medical device industry," suggests Quaid. "There will need to be resources made available at the Commission and the member states for carrying out all the additional functions set out in this regulation. Companies are uncertain about the resources they will need to compile the additional reports required annually, which will need to be properly resourced in order to complete them in a manner that meets the new requirements."
What are some of the challenges in keeping pace with the EU-MDR time line's countdown to 2020?
"I agree with Jennifer," says Quaid. "If you haven't started breaking it down, you are way behind. Many parts of the regulations are not straight forward, and there are a lot of changes and inclusions including changes, such as in classification. Companies would not only need to have started the interpretation and assessment of their systems and devices against the new regulations, but also find ways, and the resources, to keep pace with the changes as they occur."
For Quaid, three challenges in meeting the timelines stand out. The first challenge comes with new clinical requirements. The second challenge applies to changes regarding Notified Bodies.
"If you are forced to change Notified Body - if they do not get designation to the new regulations - then getting that Notified Body onboard and getting all your devices certified could be challenging," warns Quaid. "Third, having all the relevant restrictive substance information available to complete the general safety and performance requirements could also be challenging."
One of the greatest areas of concern surrounds the governance structures needing to be in place to ensure the regulations are understood, workable and implemented in a harmonized manner across the EU member states.
"We also need to ensure that at the end of this process, we have an adequate number of Notified Bodies designated to work in the Medtech space," concludes Quaid. "Stakeholder involvement is critical in all these areas and Cook, as they have always done throughout their history, is willing and able to provide insight and guidance on how this should happen."
First and foremost, says Lavender, Cook Medical welcomes and supports the efforts of the EU authorities and all those involved in bringing this regulation into force. By maintaining the core of the CE mark system and by addressing gaps, we are entering an exciting time for the regulatory process in the EU.
"Cook is proud of its involvement in the process thus far and we actively supported many of the changes including the enhanced oversight and designation of the Notified Bodies who operate in the Medtech space" states Lavender.
From an operational perspective, Cook's efforts are aimed at structuring work in such a way that it can change as necessary, notes Lavender. All three executives agree that meeting the enhanced CE requirements under EU-MDR will be a challenge, yet changes to the Notified Body system are also substantial and potentially difficult to navigate.
"We want to establish best practices across all of the units to meet all of the new requirements," Lavender concludes. "We have started our journey and we look forward to the next three years as we learn and implement a harmonized approach to the implementation of this regulation across all our global sites."
About Cook Medical
Cook Medical, a designer, manufacturer and global distributor of minimally invasive medical device technology for diagnostic and therapeutic procedures has, since its founding in 1963, created innovative medical devices. These technologies include drug-eluting and bare metal stents, aortic endografts, catheters, wire guides, introducer needles and sheaths, embolization coils, medical biomaterials, contract manufacturing of biopharmaceuticals and vena cava filters. Their minimally invasive medical devices include those for radiology, cardiology, urology and women's health, critical care medicine, surgery, gastroenterology, and endovascular therapies.
About the Interviewers
Randolph Fillmore is a technical writer for Florida Science Communications, Inc.
Gloria Hall is senior editor, feature articles, RAPS Regulatory Focus.
Cite as: Fillmore, R. and Hall, G. "Responding to the Challenges of Meeting the New European Regulations Requirements. Insight from Three Global Regulatory Executives." Regulatory Focus. January 2018. Regulatory Affairs Professionals Society.