In the United Kingdom, the medical devices, including spectacle frames, falls under the jurisdiction of the Medicines and Healthcare Products Regulatory Agency (MHRA). If you are involved in the supply of spectacle frames, lenses and reading glasses, it is crucial to understand whether you need to register with the MHRA and comply with their requirements.
What is MHRA?
The MHRA is the government agency responsible for ensuring that medicines and medical devices meet applicable standards of safety, quality, and efficacy. The agency’s role includes the regulation and surveillance of medical devices within the UK market. The MHRA performs market surveillance of medical devices on the UK market and can take decisions regarding the marketing and supply of devices in the UK
Spectacle Frames as Medical Devices
Spectacle frames are classified as medical devices under UK law. Specifically, they fall under Class I medical devices according to the UK Medical Devices Regulations 2002, which align with the EU Medical Devices Directive. This classification is based on their low risk to patients and users.
Do You Need to Register?
Yes, as a supplier of spectacle frames in the UK, you do need to register with the MHRA. Here’s a breakdown of what you need to know:
- Manufacturer Obligations: If you are manufacturing spectacle frames, you are considered the manufacturer and must ensure that your products comply with relevant legislation, including CE marking (or UKCA marking post-Brexit). You must register with the MHRA to notify them of your role and the devices you manufacture. If you are manufacturing your frames outside the U.K. but importing them to the U.K. as your own brand product, then you are considered as a manufacturer in the U.K
- Importer Obligations: If you are importing spectacle frames into the UK, you need to ensure that the manufacturer is registered with the MHRA. As an importer, you also need to ensure that the products comply with UK regulations and are correctly marked.
- Distributor Obligations: Distributors must ensure that the devices they supply are compliant with UK regulations. While distributors themselves do not need to register with the MHRA, they must verify that the manufacturer or importer has fulfilled their registration obligations.
Why Registration Matters
Registration with the MHRA is crucial for suppliers of Spectacle frames; it ensures that your products are safe for consumers and that they meet the required standards. This builds trust with your customers and helps you avoid potential legal issues that could arise from non-compliance.
What are the implications of not registering with MHRA?
If you fail to register with MHRA, this means that you are not following the UK MDR 2002 regulations which can result in enforcement activities from MHRA which may lead to a hefty fine or restricting the sale of products to protect the public health and safety.
Registration for non-UK business: if you are a non-UK business and supplying spectacle frames in UK, you will need to appoint the UK Responsible Person to get registered with MHRA. If you need any help with finding the UK Responsible person, please contact us and we would be happy to help.
Conclusion
If you are involved in the supply of spectacle frames in the UK, registration and complying with MHRA registration requirements is essential. By following the necessary steps and maintaining compliance, you can ensure that your products are legally marketable and safe for your customers.
For more detailed guidance, you can visit the MHRA website.
If you need any help with the registration with MHRA, please contact us and we would be happy to help