Ophthalmic products

Legislative framework
The Medical Devices Regulations 2002 (SI 2002 No 618) came into force on 13 June 2002. They implement a European Directive, the Medical Devices Directive 93/42/EEC, which is designed to create a single market in medical devices harmonising the essential safety requirements for these products. The regulations cover the manufacture of a wide range of products including ophthalmic appliances, instruments and equipment. In addition, some ophthalmic products to which certain provisions of the Medicines Act 1968 applied, such as contact lens care products, were also brought within the scope of the Medical Devices Regulations.

Activities covered include (among others) the following activities:

• glazing - this covers cutting and fitting finished lenses into frames and is regarded as assembly (Article 12 of the Directive). All glazing shops, including those in an optical practice, must conform with Regulations 14 and 19, and must be registered with the MHRA. If your practice receives remotely edged new lenses and fits them into a new frame, this is also regarded as assembly and your practice must, therefore, be registered as an assembler with the MHRA.
• surfacing - if you carry out surfacing work you are considered to be the manufacturer of a Class I medical device. You must meet additional requirements in addition to those related to glazing shops as detailed in Regulations 13 and 17. You must also register with the MHRA.
• post-market surveillance - all serious adverse incidents involving devices covered by the legislation must be reported to the MHRA Adverse Incident Centre and manufacturers should also be informed. Details of how to report can be found on the MHRA's website or from the Adverse Incident Centre, Tel: 020 3080 7080.

The normal professional activities of ophthalmic medical practitioners, optometrists, dispensing opticians and manufacturing opticians, such as eyesight testing, dispensing and final fitting adjustments to finished appliances, are not affected by the Directive. Neither is the activity of repairing broken appliances, refitting lenses or replacing screws, etc.

The Medical Devices Directive does not cover the position of spectacle frames already owned by individuals as these have already been placed on the market and put into service. Consequently new lenses can be put into existing frames.

The CE mark
The CE mark is the symbol used by manufacturers to show that a medical device meets the relevant requirements of the Directive and that it is fit for its intended purpose. All medical devices such as lenses and frames, contact lenses and solutions, with certain specific exceptions such as custom made devices, must carry the CE mark to denote compliance with the Directive. The CE mark may appear on the product (as for frames) or on the packing (as for lenses).

All devices must meet the essential requirements set out in the Directive at Annex I. These cover general requirements concerning safety and performance, as well as more specific instructions concerning labelling.

Classification
The Directive includes a classification system based on the degree of perceived risk associated with the device. There are three classes:

• Class I covers devices considered to be low risk, such as spectacle frames, lenses, trial sets, ready made spectacles, ophthalmoscopes
• Class IIa and IIb covers devices considered to be medium risk, such as contact lenses (IIa), contact lens care products (IIb), surgical lasers (IIb)
• Class III covers devices considered to be high risk

The criteria for determining which class a device falls into are set out in Annex IX to the Directive.

Manufacturers are responsible for deciding what class their product falls into. In the main, ophthalmic devices fall into Class I.

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.

Lenses are not generally considered to be custom made devices because they are mass produced products which are then adapted for an individual's needs. However, if the degree of specific design required to produce an appliance to a professional's prescription for an individual patient is so extensive that it goes beyond mere adaptation or assembly of mass-produced devices, the finished product may be regarded as custom-made. For example, a specially designed and produced frame to correct facial disfigurement, perhaps also including a prosthesis to replace part of the anatomy, would be regarded as custom-made. Some very special lens constructions may also fall within the definition of custom-made.

Manufacturers of custom-made devices are required to register with the MHRA once they are satisfied that they meet the requirements of the Regulations. Custom-made devices should be clearly labelled as such and do not carry the CE mark. Manufacturers of Class I sterile/measuring devices, IIa, IIb and III require assessment from a Notified Body.

Further information
You can obtain registration forms RG2 and/or RG3 , registration guidance, our information pack of Directive Bulletins by contacting the MHRA on 0203 080 7300.

Regulatory enquiries regarding the Medical Devices Regulations should be submitted in writing, to the MHRA via the email - era@mhra.gsi.gov.uk  Please state clearly what information you want us to send you, together with your name and full postal address.