Preparing for compliance with the European Union’s (EU) Medical Device Regulation (MDR) is proving challenging for medical device manufacturers as meeting the rapidly approaching deadline (May 2020) for coming into operation is requiring more time and resources than many anticipated from an initial read of the regulation.
New provisions in the EU MDR may necessitate additional clinical testing, changes to supply chain partners, registering products that were not previously covered, dealing with device classification changes, additional post-market surveillance reporting, and quality system changes, among other changes, many of which are not obvious
(see figure below).
At the FDA/Xavier Medcon conference in May 2018, former longtime U.S. Food and Drug Administration (FDA) official Kim Trautman, now executive vice president for medical device international services at NSF International , characterized many of the MDR requirements as “very nuanced.” She expressed concern that “many people are not fully comprehending the amount of design and development control and risk management remediation that is going to be necessary. The expectations are very different now. The bar is clearly raised.”
As an example, she cited new risk management expectations for reducing patient risk to “as low as possible.” Previously the standard was "as low as reasonably practicable" or ALARP. The new requirement, Trautman notes, takes away some considerations about what might be practical from a business perspective. “Compound that with the fact that the new regulations talk about when risk is not reduced, that has to either be on the label on in the instructions for use. There are some fundamental shifts.”
Given the changes under the MDR, Trautman said, “Manufacturers, especially for legacy products, are going to have a lot of hard decisions to make about the amount of work that will need to be done to some of those legacy files to get the files in a shape that will be acceptable under the new requirements.”
It is important to note that the MDR requirements impact markets in addition to the EU. The CE mark needed to market products in the EU is also required by other countries, including those that have a mutual recognition agreement with Europe, and the EU candidate countries, including Albania, the Former Yugoslav Republic of Macedonia, Montenegro, Serbia and Turkey.
The Medical Device Directive (MDD) originated from trade agreement purposes. The emphasis in the MDR is now more clearly on protecting the health of European citizens. That shift has resulted in an increased level of rigor the Notified Bodies need to apply to their oversight of manufacturers. A large number of medical devices require Notified Body review and assessment to be marketed in the EU.
Change assessments from member states and the EU Commission have removed about 30 Notified Bodies, according to Qserve Executive Director and Partner Gert Bos. Some of those remaining have changed their scope of operations to focus on their core area of expertise. The reduction in the number of Notified Bodies is putting pressure on the availability of resources to the help manufacturers prepare for the MDR, in many cases creating a waiting list for their services and delays in the review and certification processes.
The MDR was published on May 26, 2017, replacing the MDD and the Active Implantable Medical Devices Directive. The MDR comes into effect on May 26, 2020. The In-vitro Diagnostic Regulation (IVDR) replaced the IVD Directive, and comes into effect on May 26, 2022. All currently certified medical devices and active implantable medical devices must be recertified in accordance with the new requirements.
The directives were applicable to member states, and national authorities needed to adopt them by changing or creating legislation. The regulations, however, are applicable and enforceable by law across the EU, and can only be changed by the European Parliament.
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In an interview with Xavier Health in late October 2018, Trautman discussed the impact of the MDR on a device firm’s quality management system (QMS), which will result in changes that are not specifically called out in the regulation.
She noted that the MDR and IVDR regulations do not specify the manufacturer’s conformity assessment route, but that most will use ISO 13485 as the means to satisfy the conformity assessment requirements.
“Manufacturers should have already been doing some gap analysis and developed work streams and distilled these requirements,” Trautman said. “But if you look at the regulations, you will not necessarily see any requirements specific to the QMS.”
However, she pointed out, QMS changes will need to take place. “You may not see work streams devoted to the quality management system, but many of the outputs from the teams tie back to aspects of the QMS that absolutely need to be addressed even though the regulation does not explicitly call out any new QMS requirements.”
Trautman said that while companies have to prioritize the critical aspects of the regulations, such as the new requirement on equivalency, “they cannot forget that to implement some of those technical changes they have to incorporate them into their QMS through design and development changes and risk management activities, which also may require time and implementation planning.”
She suggested a few questions manufacturers should ask themselves in preparation for their quality plan to remain compliant with the new regulations:
• Have any of your device’s classifications changed?
• How will the scope of your ISO 13485:2016 certification be affected once you transition to the EU MDR/IVDR to include any devices with medicinal substances, aesthetic products, etc. now covered under the EU regulations?
In a recent presentation at the Regulatory Affairs Professionals Society’s (RAPS) Regulatory Convergence Conference in Vancouver, Canada, Trautman reviewed ISO 13485 and pointed to some of the requirements for a firm’s QMS that must be taken into account when making changes to be compliant with the MDR.
ISO 13485 section 4.1.1 states that the organization must document a QMS and maintain its effectiveness in accordance with the requirements of the standard and applicable regulatory requirements, and document the role(s) undertaken by the organization under the applicable regulatory requirements. These roles may include manufacturer, authorized representative, importer or distributor.
Section 4.1.4 states that the QMS processes need to be managed in accordance with the requirements of the standard, and applicable regulatory requirements, which includes the MDR, and that changes made to the processes must be evaluated for their impact on the QMS and the medical devices manufactured.
Trautman provided a list of considerations companies should keep in mind when updating their QMS to be compliant with the MDR and ISO 13485 (see figure below).
Strategies to come into compliance with the new regulations will vary by company philosophy. However, two primary strategies have emerged, along with variants of each depending on product portfolio and the amount of resources each firm is willing to spend to keep legacy products on the market.
One strategy is to work toward becoming compliant with the MDR prior to the May 2020 deadline with as many products as possible, realizing that some legacy products may need to be dropped. Another is to work to get as many current products as possible re-certified under the MDD as close to the 2020 deadline as possible, which could allow the company up to four more years to come into compliance with the MDR for those products.
Regarding the latter option, Trautman commented, “The caveat in that thinking is if there is any change that is considered to be a significant change after the regulation is in full effect, the company has to make an application under the new regulation.” She noted that the definition of a significant change “is not clear and is not written explicitly in black and white anywhere. It is very subjective.”
Manufacturing changes happen frequently with medical device products. When a change is deemed to be significant after the new regulation is in effect, firms need to have the quality system processes and procedures in place that will meet the MDR. “They may not truly have an extra two or three years after the regulation goes into effect. They need to have the new processes and procedures in place, just in case a significant change is necessary,” Trautman maintained.
Another school of thought is that if it appears some portion of industry will not be able to comply with the MDR before it goes into effect, the EU will need to grant an extension to ensure device shortages do not occur. In an October 2018 meeting, the EU Parliament indicated that it is highly unlikely that any extension will take place. While not explicitly stated, it is likely that since it was a hard-fought battle to get some of the provisions, opening it back up would open up those old debates.
Also in October, the European Commission published a “rolling plan” that provides deadlines and a state-of-play for the implementing acts and other initiatives required to facilitate putting the MDR into operation. The Commission plans to review this document quarterly to provide industry with the latest information.
In Part 2 of this blog post, an example roadmap for planning and implementation of the EU MDR requirements will be presented. Learn how to scope and plan the transition, assess the gaps your company has, to evaluate your product portfolio and make difficult decisions regarding legacy products.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.
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