Ophthalmic Medical Devices

An ophthalmic medical device can be defined as a device that fulfils a medical purpose for use in optometry and ophthalmology. These devices range from non-invasive devices and instruments often used for diagnoses, to invasive devices, such as contact lenses (and their associated care products), and implantable devices, such as intraocular lenses and glaucoma stents. Surgical systems, including lasers and phacoemulsification machines, and surgical instruments are also examples of these devices.

We collaborate with our in-house clinicians and, where products require additional expertise,  we consultant our other technical teams covering all areas from active and active implantable, to medicinal substances, devices utilizing animal tissue and sterile medical devices.

BSI is able to offer CE certification services under the EU MDR and UKCA services under the UK MDR 2002 for ophthalmic medical devices.  Examples of products we cover include:

• Contact lenses (including cosmetic lenses)
• Contact lens care products
• Diagnostics
• Implants (including for the treatment of conditions of the cornea and glaucoma)
• Intraocular lenses
• Lasers
• Phacoemulsification systems
• Solutions (including artificial tears)
• Surgical instruments

For more clarity on ophthalmic and related medical devices, please refer to the MDR (EU) 2017/745 and the UK MDR 2002.

Our team has a broad range of experience, including product design and development, manufacturing, sterilization, and product testing.

Our ophthalmic technical specialists are product experts who understand the specifics of these complex medical devices. Members of the team have an average of 20 years’ industry and regulatory experience. We are highly trained in working with ophthalmic device manufacturers who specialize in a variety of fields, including cataract surgery, corneal and scleral implants, glaucoma, refractive correction, reconstructive surgery, and vitreo-retinal surgery. We also have in-house animal tissue and medicinal substance experts to support manufacturers with medical devices containing these materials.

BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme. It is critical to work with an EU notified body or UK approved body that understands the industry and has the experience to review and confirm your product’s readiness for market – efficiently, reliably and promptly.

The challenges presented to manufacturers by the introduction of the EU MDR are significant, particularly for those manufacturing implantable devices. Our experienced Ophthalmic team focuses solely on ophthalmic medical devices, enabling us to provide the guidance and resources manufacturers need to support them on their journey to bringing their product onto the market. For CE marking, we have developed MDR Best Practices Guidelines to assist with this.