Manufacturers Go All Out to Meet New EU MDR Standards

随着欧盟新的医疗设备法规（MDR）将于2020年5月26日生效，制造商正在指导大量资源来制定和实施合规策略。他们知道赌注很高，他们希望确保他们为更改做好准备。

即使对某些I类产品进行了为期四年的过渡扩展，并且可能会更接近截止日期，但欧盟MDR也对许多制造商构成了重大挑战。超过230个行业领导人对2019年的回应KPMG/RAPS survey在这个问题上，洞察力令人信服：

• Only 28 percent of companies with more than $1 billion in revenue expected full EU MDR compliance by the original May 2020 deadline.
• About 36 percent expected to spend $5 million or more to achieve compliance.
• Despite their sizable investments in the process to date, 66 percent had yet to plan for the long-term impacts the new regulations will have on their business.

受访者认为缺乏指导和足够的内部资源是重大的合规性障碍。

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估计的一些较大的医疗设备制造商正在重新部署多达25％的员工队伍，以满足欧盟MDR标准。这不是可持续模型或中小型公司可用的策略。

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 adecrease 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.

当公司评估其产品中的哪些产品值得保留在市场上，以及库存的哪些部分可以减少或过时，因此欧盟中某些设备的可用性可能会受到限制。这可能会剥夺他们想要和需要的产品。同时，可以实施全面，高效和及时的欧盟MDR战略的制造商可以获得市场份额。

欧盟MDR和ISO 13485：2016

In its updatedregulatory agenda, the FDA announced that draft rules to harmonize the agency’s Quality System Regulation with international standardISO 13485：2016将于2020年4月吗, following two previous extensions.

Although the FDA状态that “the revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements,” compliance with ISO 13485:2016doesn’t guaranteea 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

欧盟MDR和ISO 13485：2016share 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 approximatelyEUR 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 Actalent. 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 Actalent now.