Exploding the Regulatory Landscape

Dermot McGrath reports

Arising from a series of damaging healthcare scandals and a widespread recognition of the need to overhaul a system no longer fit for purpose, the new European Union Medical Device Regulation (EU MDR No. 2017/745) and In Vitro Diagnostic Regulation (IVDR) represent the most significant overhaul of the EU medical device regulatory environment in more than 20 years.

Governing the production and distribution of all medical devices in the EU, the MDR entered into full force on 26 May 2021 after a one-year delay related to the COVID-19 pandemic. While the implementation of certain MDR provisions was initially to extend to May 2024 for medical devices approved under previous regulatory directives, the EU Health Commissioner proposed an additional extension following a backlash.

The implications for the ophthalmic industry in Europe are wide-reaching. The designation of medical devices encompasses a broad range of products. Surgical instruments, artificial tears, viscoelastics, intraocular lenses, corneal and scleral implants, glaucoma stents, and laser and phaco systems, among others, will all have to adhere to the new regulations or face eventual market withdrawal.

Many experts believe the stricter MDR demands will result in longer certification times and increased costs with no guarantee of improved patient safety - the ostensible reason for MDR’s introduction in the first place. In addition, the current lack of infrastructure to process device applications, and the fact many device manufacturers severely underestimated the work involved, has led to a massive backlog.

“Despite everyone’s best efforts, it is clear that not all products will get certified in time,” said industry veteran James V (Jim) Mazzo. “While there are mechanisms that can provide ways to maintain the flow of products to hospitals and patients until bottlenecks are resolved, if needed, the EU could also delay the implementation of some requirements.”

Time running out

As a board member of the Medical Device Manufacturers Association (MDMA), Mazzo said the medical technology industry supports responsible regulation, but the clock is running out for many device manufacturers to get their products certified in time.

“We want to make sure the regulations as implemented will be reasonable, and any dislocations will be temporary,” he emphasised. “Maintaining patient access to medical devices is critical. The EU Commission should eliminate unnecessary disruptions and impediments to achieving this goal, even if this means prioritizing or pausing the implementation of certain regulations.”

Tim Clover, CEO of ophthalmic products manufacturer Rayner, said the cost to obtain certification has been substantial, with the more stringent requirements for clinical data under the MDR stretching the resources of many companies.

“New product registrations are now much longer and require significant clinical studies—which are becoming harder to undertake, especially on older products. We hired a much bigger regulatory affairs and eye science team, invested significantly, and can confirm that all our products will be certified under MDR,” he explained. “Smaller companies or even bigger companies with small product lines will certainly withdraw products from Europe. My understanding is only 15% of the 500,000 products on the market are currently approved. The net effect will be reduced choice, higher prices, and longer innovation cycles.”

Kris Morrill, Founder and President at Medevise Consulting, said companies of all sizes massively misinterpreted the seismic shift MDR represented for the medical device industry. Notified bodies, the organisations designated in European countries to assess the conformity of certain products before market placement, are obligated to be much stricter post- MDR in all aspects of certification.

“Many companies wrongly assumed having good relations with their notified body over many years would automatically carry over into the new environment,” she said. “And they were shocked when they realised this wasn’t the case. The big players have a bit more of an advantage because they can spend money to fix the situation, whereas smaller companies don’t necessarily have the resources to do so.”

Clinical data challenges

One of the key challenges, Morrill said, is the MDR puts far greater emphasis on clinical data collection than the previous regulatory process. The result is many companies lack clinical data for their legacy devices.

“In ophthalmology, very few clinical studies were ever conducted to bring products to the market. It was very unusual for companies to do. They would do them for the FDA but would usually skip Europe,” she observed. “It is also extremely difficult to design studies for some technologies such as phacoemulsification systems because there are so many variables involved. So, figuring out what needs to be done to obtain certification is a major challenge even for bigger companies.”

Steven Bridges, an expert in European healthcare policy, said ophthalmic surgeons may not realise the full impact until they can no longer obtain a product they’ve used for years.

“If something is not fixed in the next six months, surgeons will start to increasingly find that a product they like to use isn’t on the shelf anymore. They may have to use an alternative they find less ergonomically pleasing or with less impressive clinical outcomes in their experience,” he said.

Although drawn up with enhanced patient safety in mind, politicians and policymakers did not necessarily understand the vast scale of the medical device sector and the tens of thousands of products. To try to limit the potential impact of forced product withdrawals, Bridges advised ophthalmologists play their part by raising awareness of the issues.

“Ophthalmic surgeons can bring it to the attention of their hospital CEOs or raise it with anybody they know in government about how important it is to patient outcomes that they have these ophthalmic devices on hand. [They can stress] Europe is competitive in how quickly devices come to market safely and appropriately,” he said.

Stifling innovation?

The fear of Europe losing a competitive edge through tighter regulation has been consistently flagged by business leaders ever since the EU Commission first mooted the need for stricter controls.

“The EU will always be an attractive market for industry. However, during the transition stages of the MDR, the EU market could lose some of its competitiveness and attractiveness,” suggested Mazzo. “We hope those dislocations will be temporary and addressed through streamlined regulations and processes.”

The concerted effort to ensure legacy devices attain certification may also obscure the damaging impact the MDR may have on new devices.

“Many of these new devices could be innovative and of great potential benefit to patients,” Bridges emphasised. “We are so focused on not losing legacy devices that we forget about the next generation of products.”

For ophthalmologists, a major concern is no longer having access to the latest technologies as companies shift market focus outside Europe.

“Europe will be at a competitive disadvantage,” said Arthur Cummings MD, an ophthalmologist based in Dublin, Ireland. “My practice will be at a disadvantage - and so will my patients, with a smaller choice of products for their needs. Price increases are also inevitable in this hyperinflationary period, and there are additional supply chain challenges to consider.”

The knock-on effect may be lower reimbursement rates for physicians as health systems try to curtail the overall costs of providing care. “Physicians are often the soft target, and they seldom put up much resistance,” Dr Cummings said.

Greater protection for patients?

While greater patient protection is a virtuous goal, Dr Cummings felt the EU may have overreached with the MDR. “I have a feeling the baby has been thrown out with the bathwater, and the pendulum may have swung too far,” he posited. “In the long term, the lack of innovation and timely access to appropriate technologies and therapies may be an issue with equally negative impact on patient care.”

Clover is also not entirely convinced the MDR will offer enhanced safety. “I’ve never seen any safety targets, which is odd since this is why it was introduced. I’m also not sure a large gap exists between the US and EU safety which could make this a waste of time, leading to slower innovation and substantially higher costs,” he said. “Ultimately hospitals and governments will pay for the MDR, so expect a period of rapid medical device price inflation for the next three years. Since the PIP breast implant scandal in France initiated the process, it’s worth noting the MDR would not have prevented it since it was already illegal under the MDD.”

Not everyone felt, however, that Europe will lose a competitive advantage once companies adapt to the reality of the MDR.

“It still takes twice as long to get on the market in the US for implantable devices,” said Morrill. “It’s easier for companies to blame the regulators and present a doomsday scenario of Europe losing competitiveness than admit they didn’t do their due diligence in terms of planning for the MDR.”

Morrill advises companies to embrace change and seize the opportunity the MDR represents.

“This is not going away, and we’ve got to learn to live with it. So, is it not better to learn how to work within that environment and do what needs to be done? At the end of the day, companies [will] be in a better position to have clinical data they can use for marketing and promote their clinical results,” she said. “People often fail to understand that just because you have to do something for the MDR doesn’t mean you can’t use it for other things.”

Steven Bridges is an independent public affairs professional based in Brussels, Belgium. steve@bridges.be

Tim Clover is CEO at Rayner, a UK-based manufacturer of ophthalmic medical products. timclover@rayner.com

Arthur Cummings MD is Consultant Eye Surgeon and Medical Director, Wellington Eye Clinic and Consultant Ophthalmologist at The Beacon Hospital, Dublin, Ireland. abc@wellingtoneyeclinic.com

James V Mazzo is Executive Chairman of Neurotech, a retinal implant company and an advisor for Avellino Labs, a biotechnology and genetic science company. mazjim@me.com

Kris Morrill is Founder and President at Medevise Consulting based in Strasbourg, France. kris@medevise-consulting.com