The EU’s Medical Device Regulation ushers in a new era of compliance. EASi offers advice on how companies can successfully meet these regulatory standards.
With the European Union’s new Medical Device Regulations (MDR) set to go into effect on May 26, 2020, manufacturers are directing considerable resources to develop and implement compliance strategies. They know the stakes are high and they want to ensure they’re well-prepared for the change.
Even with a four-year transition extension for some Class I products — and the possibility of additional extensions closer to the deadline — the EU MDR poses significant challenges to many manufacturers. More than 230 industry leaders responded to a 2019 KPMG/RAPS survey on the issue, and the insights were compelling:
The respondents identified a lack of guidance and sufficient internal resources as significant compliance barriers.
While more modern, rigorous EU regulations and compliance processes promise increased patient safety and industry transparency, it’s clear that getting there won’t be easy.
EU MDR Challenges for Manufacturers and the EU Population
It’s estimated that some larger medical device manufacturers are redeploying up to 25% of their workforce to meet the EU MDR standards. That isn’t a sustainable model or a strategy available to small and mid-size companies.
As a regulation — not a directive — EU MDR terms are legally binding and not open to negotiation among member states. That should make managing portfolios across multiple countries easier, although members still have the right to ban or impose special registrations on high-risk devices.
However, the EU MDR’s stricter guidelines include reaccreditation of Notified Bodies (NBs). That is resulting in a decrease of NBs, as many that are currently accredited may not meet the new standards. And with Brexit now a reality, manufacturers who have been working with NBs based in the United Kingdom may be reluctant to continue those relationships, adding to the approval bottleneck.
As companies assess which of their products are worth keeping on the market and what parts of their inventory to cut back or make obsolete, the availability of certain devices in the EU may be curtailed. This could deprive the population of products they want and need. At the same time, manufacturers who can implement a comprehensive, efficient and timely EU MDR strategy are in a position to gain market share.
The EU MDR and ISO 13485:2016
In its updated regulatory agenda, the FDA announced that draft rules to harmonize the agency’s Quality System Regulation with international standard ISO 13485:2016 will be released in April 2020, following two previous extensions.
Although the FDA states that “the revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements,” compliance with ISO 13485:2016 doesn’t guarantee a company’s Quality Management System (QMS) meets all of the EU MDR requirements.
With the EU MDR’s expanded focus on the entire product life cycle — from product development to supply chains to post-market monitoring and reporting — companies may need to adjust their existing QMS to ensure global compliance.
Aligning EU MDR Compliance Strategies with Company Goals
The EU MDR and ISO 13485:2016 share a common focus: to streamline processes; address the long-overdue need to account for technology’s impact on the medical device industry; and — most importantly — to positively impact patient care and satisfaction.
Stakes are high for the EU and the manufacturers who do business there, considering the industry generates approximately EUR 100 billion in sales annually, with more than 500,000 medical devices currently in circulation.
Even with deadline extensions, companies will face internal and external challenges in this new regulatory environment. The KPMG/RAPS survey concluded that “without adequate planning and budgeting, EU MDR sustainability compliance efforts could have the unwanted impacts of strained resourcing, employee resistance, insufficient training and communication failures across the organization.”
One way to address strained resourcing and other unwanted impact is to utilize external expertise through a services provider like EASi. Contract personnel can conduct a gap analysis and remediate existing design history files to be compliant with EU MDR regulations, ultimately accelerating the device approval process.
Regardless of what strategies medical device manufacturers employ, the risks and rewards of the new decade’s regulations are significant. Companies that can implement systems and processes that enhance product quality will contribute to better patient care and outcomes.
Want to know more about available support for EU MDR compliance? Contact EASi now.