Does your practice import frames from outside of the United Kingdom? Many practices enjoy a frame buying trip to Silmo or Mido, where the choice of frames from independent suppliers can provide a competitive advantage in the marketplace and some more interesting and unique styles for customers.
Many practices, however, do not realise that in bringing frames into the UK from a manufacturer who is not registered with the Medicines and Healthcare Regulatory Authority (MHRA) is illegal and can result in fines or even imprisonment.
In addition, any practice that is doing so is unwittingly taking on the role of the UK Responsible Person (UKRP), a role that has specific responsibilities in law.
The role of the MHRA
The MHRA regulates medical devices, medicines and blood components for transfusion in the UK. In the EU, the same role is undertaken by the European Medicines Agency (EMA). For optical practices this is relevant as spectacle frames and lenses are medical devices both individually and in combination medical devices.
Important definitions
Under the Medical Devices Regulations 2002 (SI 2002 No. 618 as amended) (UK MDR 2002) (Government, 2024) the following definitions are in force:
‘Medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
- Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
- Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
- Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state
- Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
- Devices for the control or support of conception
- Products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.
If we think about this definition and the items we would find in a practice, we can easily come up with examples of medical devices: a phoropter for the diagnoses of ametropia, a perimeter for the diagnosis of visual field loss or certain eye diseases, or an OCT for the detection and monitoring of disease.
These are obviously medical devices and were you to look on the MHRA Public Access Registration Database (PARD), you would find the likes of Zeiss, Nidek or Topcon registered as manufacturers and a list of all their medical devices.
However, it is not just the big ticket items used in the eye test that are medical devices. The test chart, the stereo 3D fly and the Ishihara test are all medical devices under the regulations and, from the definition, so too are spectacle frames: ‘The diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.’
Spectacles and lenses combined are intended for the treatment (myopia control) or alleviation of disease (ametropia). This combination is called a procedure pack and many practices with instore glazing will have already registered with the MHRA as producers of procedure packs.
If you have not, you can find details on how to do so on the Federation of Optometrists and Dispensing Opticians (FODO) website.
The other way in which we can identify a medical device is the manufacturer’s ‘intended purpose’. This is defined in the MDR as: the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation.
It is clear again from this that spectacle frames are a medical device and so too are items like dry eye goggles, as the intended use is to alleviate disease.
‘Manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.
‘Importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market.
‘Distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service.
‘Putting into service’ means the first use of a product for its intended purpose by an end-user. (Unusually, this makes the patient the person putting the device into service, where normally the user would be a professional.)
‘United Kingdom Responsible Person’ (UKRP) is a person or legal entity in the UK who acts on behalf of a manufacturer outside the UK.
The responsibilities of the manufacturer
The MDR sets out the obligations of the manufacturer when placing a medical device on the market. The full details can be found online.
1. Quality management system (QMS):
- Establish, implement and maintain a robust QMS compliant with ISO 13485.
- Continuously improve the QMS.
2. Design and development:
- Conduct a thorough risk management process to identify, assess and mitigate risks.
- Design and develop devices that meet essential requirements and specific requirements.
- Prepare and maintain technical documentation.
3. Clinical evaluation:
- Conduct appropriate clinical evaluations to demonstrate the safety and performance of the device.
- Review and update clinical evidence as needed.
4. Vigilance and post-market surveillance:
- Establish and maintain a vigilance system to monitor the safety and performance of the device post-market.
- Report serious incidents and adverse events to competent authorities.
- Conduct periodic safety update reports (PSURs) to assess the device’s safety and performance.
5. Regulatory compliance:
- Comply with all relevant regulatory requirements, including those related to registration, labelling and clinical trials.
- Keep up to date with regulatory changes and adapt their processes accordingly.
Remember, the UKRP takes on the obligations of the manufacturer where the manufacturer does not have a UK presence, and if your practice is importing frames from the EU, then your practice is taking on the role of the UKRP.
Examples
Practice A buys only frames from a UK manufacturer of frames or a manufacturer with a UK based entity, and they have all their glazing and assembly carried out by a UK based lab. They have no requirement to register with the MHRA.
Practice B only buys frames from a UK manufacturer of frames or a manufacturer with a UK based entity, but they glaze in-house. This practice is required to register as a manufacturer with the MHRA. The same would be true if they carried out remote edging.
Practice C buys frames from UK manufacturers but also buys frames via a distributor of a French manufacturer that has no UK based entity. In this instance, the distributor needs to register with the MHRA via the UKRP, and the practice should ensure that this has been done before they purchase. The distributor and the importer are often the same entity, but do not need to be.
Practice D buys frames from a French manufacturer after seeing the frames via a representative, but the sale is direct with the manufacturer in France and they pay import duties on the delivery.
In this instance, the practice needs to be registered with the MHRA as an importer via a UKRP. Before this can happen, the manufacturer needs to appoint a UKRP to act on their behalf.
As for frame manufacturers based in the UK, they too should have registered their products with the MHRA, the exception being if they are producing custom products or one-off frames for a specific individual – these are exempted.
What should you do?
Review these scenarios and apply them to your practice, then act accordingly. If you fall into category C or D, check the PARD database and ask the manufacturer or distributor to provide evidence they are registered or have a UKRP in place. If they do not, you are taking on that role.
Remember, to place a medical device on the market that is not registered with the MHRA can attract penalties.
As you can see, there is quite a lot to consider as a manufacturer of medical devices, but importantly, under Article 16 of the MDR for manufacturers outside of the EU, the importer takes on the responsibilities of the manufacturer. So, as an optical practice buying frames like Practice D, you are acting as the importer.
The appointment of a UKRP by the manufacturer moves a lot of these requirements away from the practice, with the UKRP being responsible for holding the technical documentation and registering the importers (the practices) with the MHRA and being a point of contact with the MHRA and the manufacturer.
Who can help?
There are many quality and regulatory consultants in the UK who can provide advice, act as a UKRP, or support practices registering with the MHRA, either as manufacturers or as importers. Professional bodies, such as the Association of British Dispensing Opticians, FODO, the Association of Optometrists or the Optical Suppliers Association, should be able to provide advice and point you in the right direction.
- Jim Cox is a dispensing optician and the director of IgniteQA Ltd, a Quality Assurance consultancy with a specialism in medical devices and support for optical practices.
