If you thought rocket science was complex, take a look at the European Union’s (EU’s) medical device regulations (MDR), set to go into effect on May 26, 2020. Not only are the rules complicated and far-reaching, but they will touch companies that never before had to think about such things. Examples are manufacturers of contact lenses and other products used in or on the eye; products used for liposuction or lipoplasty; products used in high-intensity radiation equipment used for tattoo and hair removal; and equipment using electrical or magnetic currents to stimulate the brain.
Questions around the rules are manifold — from what to do and when, to interpreting the many acts of compliance (still not fully fleshed out), to how the regulations might change the competitive landscape and their impact on companies of varying sizes and product categories.
Many questions remain, including around Brexit
The medical technology industry has collectively voiced real concerns about its ability to demonstrate readiness and absorb all the changes that the EU MDR is exerting on organizations. Two questions are dominating discussions: Will all the EU MDR rules be in effect on the application date? And if the regulations go ahead as planned, will there be flexibility in the level of enforcement that regulators will apply?
Two questions dominate: Will EU MDR rules be in effect on the application date? And if the regulations go ahead, will there be flexibility in the level of enforcement applied?
There has been much pushback around the date, not only from the United States but also from a major European trade association, said Marty Zuzulo, a director in Grant Thornton LLP’s Life Science’s Regulatory and Compliance practice. “Uncertainty is pervasive, especially in terms of the shortage of guidance that the EU has been giving industry and in terms of stakeholders pushing against the implementation date. Add to this the uncertainty that Brexit, and the potential for extensive supply chain disruption, introduces, and much remains in flux.”
Brexit issues are not confined to the UK, he said. “A critical impact that Brexit has introduced into the MDR conversation is that a notified body [NB], which assesses the conformity of products before their placement in the EU market, must have the legal address of its headquarters within the EU.” Zuzulo explained that if the UK “Brexits,” the five organizations that have so far been designated NBs for medical devices will need to maintain an EU legal business residence. In at least one instance (that of BSI UK), this has meant relocating headquarters from the UK.
In August, Dekra Certification GmbH and IMQ S.p.A joined TUV SUD and TUV Rheinland to become part of a small cadre of NBs. These organizations are now taxed with the responsibility of supporting and clearing a significant volume of technical file evaluations, conformity assessments and CE markings. [CE is from the French phrase "conformité Européene," which means European conformity.] These five also represent a far cry from the 20 NBs the European Commission (EC) forecast that it would designate by the end of 2019, which calls into question whether this regulatory and compliance “supply chain” will be able to keep pace with current and future pipelines.
Supply chain worries
“The potential UK exit from the EU is also introducing supply chain and other concerns that remaining countries are going to have to absorb,” said Zuzulo. One underappreciated set of requirements that has been amplified in the new legislation relates to economic operators — that framework of authorized representatives, distributors, agents and suppliers that, to varying degrees, “touch” the product. The new legislation makes more explicit the need to qualify suppliers under the same requirements (e.g., source documentation, training, maintenance of quality management systems [QMS], etc.) as the device companies themselves.
Pat Shafer, managing director in Grant Thornton’s Life Science’s Regulatory and Compliance practice, added, “Companies are responsible for suppliers and distributors — the entire chain of custody, from product development to the patient. Overall accountability remains with the registering company.”
The amount of clinical evidence that companies will need to provide is another supply chain challenge. Every product seeking a CE mark will need to be supported by clinical evidence, so existing studies, published literature or studies previously initiated by investigatory bodies may satisfy these requirements — but they may not. New, post-market studies may have to be conducted, especially for “up-classified” products or in cases where supporting studies are older. Zuzulo offered, “Our observation is that some companies have underestimated the degree to which new studies will be required, and will have their timelines and budgets impacted to address the challenge of keeping products in the market.”
Some companies have underestimated the degree to which new studies will be required and will see timelines and budgets impacted to address the challenge of keeping products in the market.
In addition, the EU MDR is introducing more substantial requirements that relate to labeling and packaging. Under the EU MDR and the EU in vitro diagnostic regulation (IVDR), every label for every affected product will change. How to manage the translation of labels into all EU languages and determine which materials require printing or website reference, and anticipating where symbology guidance will fall, are just a few of the fundamental actions the industry is contending with.
The concerns also extend into the “back end” facets of the label supply chain: Companies whose distribution centers are responsible for on-demand printing need to have visibility into the latest artwork, specifications and released labelling. The challenge in maintaining product continuity in the EU is increasingly evident when viewed through this lens.
Closely related to these labeling impacts are the new EU MDR requirements around the Unique Device Identification (UDI) system, which will now require that these identifiers be added to labels.
Another challenge to industry is that these data will also be entered into the much more broadly developed version of the European database on medical devices, or Eudamed. Many of these data requirements may affect master data and product information management systems and processes.
The United States weighs in
A recent voice expressing concern about the lack of guidance from the EU, the shortage of certified NBs and the aggressive implementation timeline, is the United States. In a July 24 statement to the World Trade Organization’s Committee on Technical Barriers to Trade, a U.S. delegation cited the lack of NBs to support transitions and the lack of action on the part of regulators to promote compliance. The EC has defined only two of the implementing acts, and just one has been adopted.
Specifically, the United States has argued that MDR provisions have been insufficient and urged a three-year delay in the implementation date. If not a delay, the argument goes, the EU should allow U.S. legacy products currently sold on the EU market to continue to be sold until 2024, under current certification to the EU Medical Device Directive.
Others weigh in
Although the United States argued that MDR provisions have been insufficient and urged a three-year delay in implementation, the chances of a dramatic timing change are slim.
The voices extend across the pond as well. Previously, MedTech Europe, a leading medical products advocacy group, said implementation of the new regulations by May 2020 was “clearly untenable,” and it warned of potential access issues to medical technologies. Limitations under current rules could worsen under the directives and leave some manufacturers temporary “orphans.” In at least one position paper to the EC, it offered a number of actions to ensure a smoother transition process, greater clarity in guidance supporting the interpretation of the regulations, speeding up NB designation, and provisions to keep critical medical products on the market.
At the recent MedTech annual conference in Boston, these challenges were acknowledged in several panels comprising health authority, industry and advocacy participants.
Slim chances of date move-back
Zuzulo believes the chances of a dramatic timing change are slim. While certain products within the EU’s Class I designation do not require NB certification of a QMS, Class II and III products do, and there is the potential of derogation for those classes, he said. “The possibility remains that the EC may extend the timings for certain classes or products within each class. Other options may address the timings for IVDR past the 2022 application date. These are only possibilities, but the one certainty is that the EU will not apply wholesale relief to industry,” he said, “so industry has to be prepared.”
For example, the most notable change announced recently is that the launch date for Eudamed has been shifted from May 2020 to May 2022. In this instance, derogation applies to the electronic exchange of information/upload to Eudamed, not to the actual preparation and submission of data. The example illustrates the tightrope position the EU must walk.
Coping with change and gaining advantage
Amid the flux in what is changing (and what is not), companies can take definitive steps in gaining advantages in this environment.
The consensus guidance offered by participants at the MedTech Conference took the view that health authorities and industry will need to operate on a theme of “best intentions”:
- Do what is best for patients.
- Work in building strong collaborations with health authorities; uncertainty will require more collaboration, not less.
- Look to derogations on an ad hoc basis.
Companies need to assume that all EU MDR regulations will be enacted, so they should continue unraveling the MDR challenges and determine the issues most pertinent to them. Operating under the assumption that the MDR will go through as stipulated, questions that will drive the next phase in readiness include:
- If I assume that all regulations will remain intact, which do I need to prioritize?
- What are the critical areas within the legislation that can slow my progress or impact my products’ chances of staying in the market?
- What are my most thoughtful and defendable strategies in explaining regulatory and quality rationales to health authorities?
The EU MDR and EU IVDR compliance effort continues to be cryptic, significant and expensive. It will also significantly increase time to market in the EU. But by adopting a flexible approach, choosing the right priorities, effectively rationalizing products and strengthening collaborations with regulators, companies can chart a path toward regulatory clarity and strategic advantage.
Life Science’s Regulatory and Compliance practice
+1 609 462 0070
Life Science’s Regulatory and Compliance practice
+1 646 379 8307