Spectres Haunting Europe

PAUL ROSEN FRCOPHTH, MBA

Aspectre is haunting Europe—a new regulatory environment that will affect every ophthalmologist working in the EU and beyond.

This issue of EuroTimes features two articles by contributing editor Dermot McGrath considering issues associated with the European Union’s new Medical Device Regulation (MDR) policy change—the biggest shake-up of the regulatory environment in the past 20 years—with a particular focus on the impact on the ophthalmic industry, ophthalmologists, and patients.

Many companies have been underprepared or underestimated the requirements of the new certification process, particularly in terms of collecting clinical data, starting a frantic scramble to obtain certification for countless legacy devices before the grace period was due to expire in May 2024. Certifying bodies are unable to cope with the demand, raising mass withdrawals of what will be uncertified products. Critics say the MDR will stifle innovation and increase costs with no guarantee of enhanced patient safety. Following a backlash, the EU Health Commissioner has proposed an extension of the deadline by a few years and cancelled the requirement for products currently on the market to be thrown out.

We would all support appropriate regulation to protect patients first and foremost, but the doctors using the devices and the manufacturers developing and selling them, too. However, any regulation must not stifle innovation and allow for the continued use and development of low monetary value, low margin but high clinical value products. We need a form of “grandfather rights” for the orphan products we rely on for safer surgery (e.g., trypan blue), which major manufacturers do not necessarily support.

It is worth remembering what brought about the changing MDR regulations: a series of several high-profile scandals involving medical devices. A second article in this issue reviews these in detail, including toxic vitreoretinal PFO and silicone oils that left scores of people blind or severely debilitated, and how the MDR will hopefully help prevent reoccurrence.

Another very real spectre is also haunting Europe, that of the Russian invasion of Ukraine, now entering its second year. ESCRS Managing Director Tom Ogilvie-Graham features in an article discussing the realities of providing medical aid in a conflict zone.

The ESCRS will continue to support Ukraine, providing much-needed medical and surgical supplies as well as educational opportunities and financial benefits for Ukrainian ophthalmologists. We are very grateful for the continuing support we are receiving from the industry and our members. For more information on contributing, please see page 14.

Editorial Board

International Editorial Board

Noel Alpins (Australia)

Bekir Aslan (Turkey)

Roberto Bellucci (Italy)

Hiroko Bissen-Miyajima (Japan)

John Chang (China)

Béatrice Cochener-Lamard (France)

Oliver Findl (Austria)

Nino Hirnschall (Austria)

Soosan Jacob (India)

Vikentia Katsanevaki (Greece)

Daniel Kook (Germany)

Boris Malyugin (Russia)

Marguerite McDonald (US)

Cyres Mehta (India)

Sorcha Ní Dhubhghaill (Ireland)

Rudy Nuijts (The Netherlands)

Leigh Spielberg (The Netherlands)

Sathish Srinivasan (UK)

Robert Stegmann (South Africa)

Ulf Stenevi (Sweden)

Marie-José Tassignon (Belgium)

Manfred Tetz (Germany)

Carlo Enrico Traverso (Italy)