MDR Requirements Affect All Ophthalmic Surgeons

Ophthalmology needs to come to grips with medical devices under new EU regulations.


All surgeons should familiarise themselves with the Medical Device Regulation (MDR) that entered into force in May 2021 and signal any safety incidents connected with the use of a medical device to the relevant health authorities, according to José-Carlos Pastor MD, PhD.

“MDR is really complex, but the key points are that all medical devices require clinical evaluation and investigation with the same ethical, methodological, and patient protection principles as clinical drug trials,” he said. “The products from clinical research must be provided free of charge by the sponsor, and any clinical trials must be covered by insurance.”

Prof Pastor focused his talk on the surveillance measures in place to flag any issues of concern with any medical device.

“Healthcare professionals or patients who become aware of a serious incidence must report it to the country’s health authorities. Health facilities must appoint a surveillance officer to comply with established procedures,” he explained. “The clinical sites must also have a record, preferably electronically, of the Unique Device Identification (UDI) of implanted devices IIa, IIb, and III.”

He noted the vast majority of implanted devices used in ophthalmology—including contact lenses, IOLs, surgical lasers, scleral and corneal implant instrumentation and sutures—come under class IIa or IIb.

What constitutes a serious incident?

The question frequently arises as to what constitutes a serious incident which warrants reporting, Prof Pastor explained. Although the MDR itself lacks a clear definition of the difference between an “incident” and a “serious incident,” a European Union medical devices working group has since clarified the terminology. A “serious incident” is defined as one with the potential to lead to significant health or public health outcomes and may have resulted in or contributed to the death or temporary or permanent serious deterioration in the health of the patient or user.

There are three main criteria governing basic reporting criteria for a serious incident: an incident has occurred, the incident directly or indirectly led or might lead to any of the outcomes of a serious incident, and a causal relationship between the serious incident and the device has been established, is reasonably possible, or suspected. Any incident which meets all three of the above conditions is considered a serious incident and should be reported, he said.

In Spain, Prof Pastor and his team have been working with ophthalmological societies and opinion leaders to propose a list of possible serious events to help colleagues make decisions concerning MDR reporting.

The Spanish Vitreoretinal Society (SERV) has proposed a list of possible serious incidents, including those arising from the use of irrigation solutions, such as cataract formation, endothelial decompensation, or unusual inflammatory reactions.

“We should also be aware that some surgeons use low concentrations of povidone-iodine in the infusion liquid to treat or prevent infectious endophthalmitis,” he said. “They are anecdotal but could cause inflammatory reactions and endothelial toxicity, and they must be taken into account.”

A wide range of criteria for reporting issues with silicone oil use—including vision loss, unusual inflammation, sustained IOP rise, and retinal structural changes, among others—have been identified and should be considered when an incident occurs, Prof Pastor said.

He also advised caution when using so-called facilitators of silicone oil removal such as F4H5, noting there is currently little scientific basis for their safety.

Caution is also advised with perfluorocarbon liquids (PFCLs) use, which can cause inflammatory reactions and a direct toxic effect, while problems may also occur with internal limiting membrane dyes and perfluorocarbon gases.

Summing up, Prof Pastor urged practitioners to be thorough in the traceability of any medical devices they use.

“If possible, keep a record of the duration of your surgeries and the most important surgical steps,” he concluded. “Also, in case of reasonable doubt, it is preferable to report the incident involving a medical device to the health authorities.”

This presentation was given at the 2023 EURETINA Congress in Amsterdam.

José-Carlos Pastor MD, PhD is a full professor and chairman at the Hospital Clínico Universitario de Valladolid, Spain, and Advisor to the Spanish Agency for Medicine and Medical Devices (AEMPS).