The ophthalmic industry is a key growth area in the medical device world, with an ever-increasing demand for solutions to improve the day-to-day living of millions of people.
As a Notified Body, our core competency of ISO 13485 and CE marking are perfectly matched to handle a full range of ophthalmic products to help you get your devices to market.
Ophthalmic medical device legislative framework
Ophthalmic devices cover a wide range of design types and applications such as glasses, contact lenses, intraocular lenses, implants, diagnostics, lasers, solutions and surgical instruments. Devices may come under any of the three European Directives, the Medical Devices Directive, the Active Implantable Directive and or the In Vitro Diagnostic Directive.
BSI has experts with decades of experience in the ophthalmic sector and is designated by the MHRA under all three Directives providing a one stop shop for manufacturers certification needs.
Classification of ophthalmic medical devices
The Medical Device Directive includes a classification system based on the degree of perceived risk associated with the device. There are four classes:
- Class I covers devices considered to be low risk (may include devices such as corrective glasses and frames, eye occasion plasters, permanent magnets for removal of ocular debris)
- Class IIa and IIb covers devices considered to be medium risk (may include devices such as contact lenses, contact lens care solutions, intraocular lenses, surgical lasers, Scleral and corneal implants, instrumentation and sutures)
- Class III covers devices considered to be high risk (may include implants containing medicinal substances or manufactured utilizing tissues of animal origin)
The criteria for determining which class a device falls into are set out in Annex IX to the Medical Device Directives. Manufacturers are responsible for deciding what class their product falls into.
Active Implantable and IVD devices are classified under different systems as detailed in the respective directives.
The level of control required under the regulations depends on the classification of a product and is intended to be proportionate to the perceived risk, i.e. the controls of Class III (high risk) products are more stringent than those for Class I (low risk) products.
BSI has experience in certification for manufacturers of both high and lower risk devices.
Why choose BSI to help you demonstrate regulatory conformity?
Our team is highly experienced working with ophthalmic device manufacturers who specialize in a wide variety of fields, including refractive correction, cataract surgery, vitreo-retinal surgery, reconstructive surgery, corneal and scleral implants, and glaucoma.
Our technical experts have a unique combination of industrial and regulatory experience in ophthalmic devices, active devices, non active devices and active implantable devices.
Importantly, we also have internal experts in the fields of animal tissue and medicinal substances to support the manufacture of devices containing these types of materials.
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