An Overview of the Regulatory Responsibility of Eye Care Professionals that Perform Modification of GP Contact Lenses, a Q and A
What is GP lens modification?
Modification of a GP lens can mean many different things depending on the context:
First, modification could be a Quality Control Technician’s controlled process to remove a few light scratches on a new lens so that the lens meets the Manufacturer’s/Finished Lab’s stated acceptance criteria for surface quality.
Second, modification may refer to the return of a used lens to the manufacturer for resurfacing or power modification. For many decades, this was a common service offered by Manufacturers/Finished Labs that often involved “cleaning and polishing” or a slight power change to match a new prescription. However, there are important risk considerations for this type of modification. The actions of receiving, inspecting, and reprocessing of used lenses in a manufacturing setting introduces substantial new risks of biological contamination. Additionally, it is accepted that these types of modifications are not well-controlled when compared to the state-of-the art lathe-driven manufacturing process. The modification of used lenses introduces variables such as subtle changes to lens optical quality that can complicate the problem-solving of Eye Care Providers. For both reasons, most labs have discontinued offering this type of modification and prefer to control these variables by simply making a new lens.
Thirdly, after the lens has been placed on the market by the Manufacturer, modification is sometimes performed by an Eye Care Professional as an “in-the-field” modification. These types of modifications are not nearly as common as they once were. Now, it is estimated that only a very small percentage of Providers or Opticians perform “in-the-field” modifications. Recently, important regulatory and legal risks of this type of modification have become clear. This article will focus on the regulatory implications that are now associated with “in-the-field” modification of GP lenses.
How are “in-the-field” modifications regulated?
For many decades, the honest answer to this question would have been “not much at all”. However, two recent regulatory documents have shed light on how regulatory authorities view “in-the-field” modifications. The first is the European Union (EU) Medical Device Regulation 2017/745 (MDR)¹. The second document is United States Food and Drug Administration (FDA) Final Guidance titled “Remanufacturing of Medical Devices: Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff”², issued May 2024.
What are the regulatory implications for “in-the-field” lens modifications in MDR?
The principal goal of MDR is to significantly tighten the regulatory requirements for medical devices within the EU, enhancing patient safety and ensuring better quality and transparency. For Class IIa devices such as GP lenses, MDR requires a conformity assessment procedure involving a notified body. This 3rd party conformity assessment ensures that the legal device manufacturer is in full compliance with the “General Safety and Performance Requirements” (GSPRs) that are given in Annex 1 of the MDR. For example, one GSPR for Class IIa devices is that the product shall be biologically and chemically evaluated according to ISO 10993, Biological evaluation of medical devices.
Importantly, MDR also defines the roles and responsibilities of the “Manufacturer” and “Distributor”. It goes without saying that Eye Care Professionals play a much larger role than simply a device “Distributor”. But in the context of maintaining compliance through the supply chain, they are also defined as such. Article 16 of MDR states that certain tasks, when accomplished by a distributor, oblige these persons to meet the obligations applicable to the manufacturer.
One of these tasks is “modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected”. These requirements include biological evaluation according to ISO 10993. According to MDR, the act of “in-the-field” modification would be considered a creation of a new version of the device with potentially different biological, chemical, physical, or clinical characteristics from the original product that was placed on the market by the Original Manufacturer. In this case, the person performing the “in-the-field” modification must realize that they are effectively taking on the regulatory role and responsibilities of a manufacturer and must comply with the MDR as such.
What are the implications for “in-the-field” lens modifications in the May 2024 FDA Final Guidance Document “Remanufacturing of Medical Devices”?
In 2018, the FDA published the “FDA Report on Device Servicing”. A key finding in this report was that most complaints and adverse event reports received by the FDA that referred to “servicing” were actually found to pertain to “remanufacturing”. Therefore, the principal goal of the May 2024 FDA Guidance Document “Remanufacturing of Medical Devices” is to clarify the roles of medical device “Servicer” and “Remanufacturer”. This distinction is important because any entity in a “Remanufacturing” role has a similar burden of regulatory compliance as the Original Manufacturer.
Importantly, the May 2024 Guidance defines Remanufacturing: “The processing, conditioning, renovating, repackaging, restoring, or any other act done to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use”. Considering this definition, it also crucial to understand that FDA previously in a separate September 2023 Final Guidance Document “Use of International Standard ISO 10993-1, Biological evaluation of medical devices, etc.”³ that the biological evaluation criteria included in ISO 10993 should be used as input into a decision that determines the safety of medical devices in the United States. Therefore, any entity that performs an action to a finished device that has potential to alter the device’s safety specifications (including biological evaluation) is considered for regulatory purposes to be a “Remanufacturer”. As such, they would be expected to have a similar biological evaluation performed on the “modified” lens.
On its face, this may seem like a costly and unnecessary regulatory burden to place on an entity that performs an “in-the-field” modification. However, it is a much more reasonable requirement when one considers the validation processes required of the Original Manufacturer (design validation, biological evaluation that includes their specific processing compounds and procedures, quality control, and bioburden validation). Bioburden validation is of particular significance – the Original Manufacture arranges for routine 3rd party laboratory testing of product bioburden levels. This testing is representative of their individual manufacturing, cleaning, and packaging processes. Additionally, from a risk management perspective, the Original Manufacturer didn’t need to consider any significant risks associated with controlling biological contamination from used lenses.
The Bottom Line:
Original Manufacturers of GP lenses need to make their Eye Care Professional customers aware of the changed regulatory environment that significantly affects “in-the-field” modifications. In addition to these regulatory considerations, there are also legal implications. If desired, an Original Manufacturer can create and enter into a legal agreement with a customer related to product liability. However, such an agreement does not absolve the customer that performs “in-the-field” modifications of these regulatory roles and requirements.
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Oct 5th, 2024
Written by:
Rob Ahern
Valley Contax Operations Director