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Medical Device Makers Face Tougher Time in Europe

Medical device makers are on the verge of facing a more challenging regulatory environment in an important overseas market after decades of standards viewed as less stringent than those in the U.S.

The European Commission, which is the executive body of the European Union, published a pair of regulations that observers suggest will fundamentally change how medical devices are introduced to the European market. The rules are being phased in over several years, starting next year.

The changes are considered significant because more than a few American device makers have historically chosen to start selling their products in Europe rather than the U.S.—the Food and Drug Administration’s regulatory process is considered tougher and has therefore inspired some grumbling over the years.

Device makers also typically introduce their wares in Europe, followed by FDA approval, and then a Japanese launch about three years afterward.

The changes mean smaller U.S. device makers could have to spend more money on additional consultants’ help to handle the stricter requirements. Larger companies, especially those with established European operations, will likely feel less of an effect.

Some in the industry have blasted the changes but government officials are ushering them in after a device debacle caused public outcry.

“An FDA-like system would kill patients and kill innovative companies,” Antoine Papiernik, a partner with Sofinnova Ventures, told Reuters.

Sofinnova, a French company, has invested in OC-based startups, such as CoreValve Inc., now part of Medtronic Inc.

Lost Time

European regulators are making up for lost time according to some industry observers.

“Existing [European] legislation has not kept pace with the enormous technological and scientific progress” in the device industry, according to a white paper published by Estonian law firm Sorainen on the Lexology law website.

Some of the changes coming to Europe include:

n Device makers must appoint a “qualified person” responsible for regulatory compliance.

n Each device will be fitted with a unique identification that permits traceability.

n Clinical trials will have to be registered with a publicly accessible electronic system established by the European Commission.

n More unannounced inspections by authorities.

n Introduction of a portal through which device makers will have to report serious incidents and corrective actions. That information will be automatically available to European Union-member state authorities. It will also make it possible for device makers to examine competitors’ experiences to prevent problems their predecessors had.

The changes follow a review of the current regulations that found them lacking.

“The national regulatory authorities, competent authorities, have identified deficits in the current system,” said Mathias Schulze Steinen, a partner in the Frankfurt, Germany, office of Pittsburgh-based K&L Gates LLP, a law firm with an Irvine office.

Law firms advise device makers about regulatory changes and how to comply with them.

K&L Gates’ local clients include Irvine-based Allergan Inc., which makes breast implants and the Lap-Band weight-loss device, which it is in the process of divesting.

The current regulatory deficits Schulze Steinen referred to include what he called “the lack of a clear mandate” for regulators in the various EU countries, where they don’t have authority to ensure thorough testing and regular checks.

Another observer says what’s proving to be a slow pace of rule adoption will give device makers time to cope.

“It’s going to be one of these very deliberate and slow ramps,” Evan Ng, a partner with Minneapolis-based law firm Dorsey & Whitney LLP, said in a telephone interview. Dorsey has an office in Costa Mesa.

Smaller companies will have more time, but they will have to spend more money to comply with the changes.

Ng said he expects device makers that are “not the large [Abbott Medical Optics] types” will have to put out “more third-party expenses” for consultants to help them deal with tighter European regulations but won’t have to hire full-time regulatory staff.

“Most of those folks are not going to have in-house” regulatory people, he said. “Just because the regs change, I don’t think you go from having a VP of regulatory to have a VP of regulatory, Europe and a VP of regulatory, America.”

“Great windfall for the service providers,” Ng added.

But device makers with large European infrastructures shouldn’t have many difficulties adapting to the changes, unlike some startups, said Matthew Jenusaitis, chief executive of Octane, an Aliso Viejo-based technology booster group.

Schulze Steinen said information on the performance of proposed and existing devices will be easier to access once the changes take effect.

The new regime is expected to be “a big step forward” in terms of medical de-vice transparency, said Schulze Steinen. “There [currently] is no transparency at all.”

Schulze Steinen not-ed that today in Europe, a device maker can’t get data on a competitor’s products for comparative purposes.

Information

Data “is much easier to access in the U.S. system,” he said.

That will change soon.

European regulators today “are not required to publish any of their results of the device, meaning we all [are dealing] with a little bit of a black box in respect to getting to the market with the device,” Schulze Steinen said.

More publicly available information will be coming through Eudamed, the European Union’s data bank on medical devices.

The pending changes “will slow down the process a little bit, but it’s still expedited relative to the U.S.,” Jenusaitis said.

A report issued last year by the Boston Consulting Group that used FDA data showed that on average, medical devices have been available in Europe some 43 months before they hit the U.S. market.

Europe’s regulatory changes will affect more than getting devices to market. They’re also expected to influence medical device makers’ hiring patterns.

“What we’re finding is that over the past four years or so, positions involved in regulatory affairs, quality engineering, quality assurance, both on an international and domestic basis, seem to be growing,” Bob Jeffers, founder of Laguna Niguel-based executive search firm Allen-Jeffers Associates Inc., told trade publication Medical Device and Diagnostic Industry this year. He cited the European regulatory changes as one of the reasons for increased hiring.

Not all of the changes are in line with the FDA.

For instance, there will still be no process for premarket approvals. Those approvals are granted when regulators deem that a device will be effective and safe based on scientific evidence cited in a given application.

Premarket approvals in the U.S. are used on what are called “Class III” medical devices—those that support or sustain human life, “are of substantial importance in preventing impairment of human health or which present a potential, unreasonable risk of illness or injury,” according to the FDA’s website.

The majority of medical devices in the U.S. are cleared through 510(k), which covers incremental improvements to existing products.

Devices to be sold in Europe will instead undergo what’s called a “scrutiny procedure,” whereby a medical device coordination group made up of experts from the various European countries and chaired by the commission will review and comment on whether devices conform with rules for high-risk medical devices.

It’s considered less “bulky,” or cumbersome, than the FDA premarket process.

Due Consideration

Notified body regulators, or representatives European Union countries appoint to assure products meet standards, will be required to give “due consideration” to the coordination group’s comments and will have to justify deviating from those comments.

Europe’s push for tighter device regulation grew out of a scandal three years ago involving silicone breast implants.

Media reports showed breast implants made by France-based Poly Implant Prothese had an abnormally high rupture rate, findings that prompted an outcry over what were deemed to be substandard implants made by the company.

Poly Implant Prothese apparently was using industrial-grade silicone instead of medical-grade silicone in its implants. French authorities shut down Poly Implant Prothese in 2010.

The regulatory changes are designed to prevent such inferior products from going to market.

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