Are you thinking about placing external prostheses and orthoses devices, or even ophthalmic products on the Great Britain market? Then, make sure to comply with the following requirements!
But first, remember to verify whether your product falls under the definition of a ‘medical device’, as per Article 2(2) of the UK Medical Device Regulation 2002 (MDR, 2002).
Prosthetic and Orthotic devices:
Currently, prosthetic and orthotic products are mainly Class I devices where a CE, UKCA or CE UKNI marking should be affixed. They could also be classified as custom-made devices (MHRA, 2021).
However, as of 1 July, 2023 new devices that will be placed on the GB market shall only conform to the UKCA marking requirements. Additionally, compliance shall also be ensured in respect to the essential requirements laid down in Part II of the UK MDR 2002 (MHRA, 2020).
These rules apply to any manufacturer or healthcare establishment who supplies medical devices to be placed on the market for use or distribution, whether at a cost or free of charge. Economic operators refurbishing prosthetic or orthotic devices outside of the original manufacturer’s instructions will automatically be considered as manufacturers too (MHRA, 2021).
Moreover, for custom-made devices, the general law around consumer protection and product liability shall also be complied with (MHRA, 2021). Orthotic devices are generally custom-made – if they are composed of a mixture of Class I UKCA, CE or CE UKNI- marked devices, or if they are made to fit from casts (MHRA, 2021).
- Prosthetic Devices:
According to the MHRA, external prosthetic devices are made up of 2 parts:
– Prosthetic socket.
The final product consists of the hardware and prosthetic socket joined together as per the manufacturer’s instructions (MHRA, 2021).
- Orthotic Devices:
Most orthotic devices are classified as Class I, and include:
– Orthotic kits/parts that have been mass produced and can be adjusted according to height;
– Reciprocating gait orthoses;
– Mass produced/stock item orthotic devices which do not give energy to the user;
– Mass produced footwear and insoles or segments for making insoles (provided that the intended use has a medical function).
However, if the support for mobility works through electrical stimulation (FES), providing energy to the user, then these devices shall be considered as Class II (MHRA, 2021).
Ophthalmic products are generally Class I devices, however, classification depends upon the possible and associable risks. Examples include:
– Ophthalmic appliances;
– Contact lenses and solutions;
– Instruments and equipment.
The involvement of a Notified Body or of a UK Approved Body is required for Class Is and Im, IIa, IIb, III, and all ophthalmic products must affix a UKCA, CE or CE UKNI mark (except for custom-made devices) (MHRA, 2021).
Finally, the requirements of the UK MDR 2002 also apply to certain activities relating to ophthalmic products (MHRA, 2021). Such activities include:
– Glazing, which involves cutting and fitting the finished lenses into the frames – this is recognised as an assembly of devices and all glazing shops must be registered with the MHRA;
– Surfacing, which is to finalise the surface of the lens – those carrying out surfacing work are considered manufacturers of a Class I medical device and should follow the regulations as well as register with the MHRA; – Post-market surveillance – you must report all adverse incidents to the MHRA, if the medical device is covered by the UK MDR 2002.
The following activities shall not be covered by the UK MDR 2002 (MHRA, 2021):
– Normal activities of medical practitioners, optometrists, dispensing and manufacturing opticians (e.g. eyesight testing);
– Repairing broken appliances, refitting lenses or replacing screws, including for already used spectacles.
Francesca Romana Anedda
Regulatory Affairs Department
Are you a manufacturer of these specific medical products? Have you got any doubts about the requirements of the UK MDR? Contact us today!
- MHRA. (2021). Medical devices: legal requirements for specific medical products. Retrieved on 29.04.2021 from Medical devices: legal requirements for specific medical products – GOV.UK (www.gov.uk)
- MHRA. (2020). Medical devices: conformity assessment and the UKCA mark. Retrieved on 29.04.2021 from Medical devices: conformity assessment and the UKCA mark – GOV.UK (www.gov.uk) · UK MDR (2002). The Medical Devices Regulations 2002. Retrieved on 29.04.2021 from The Medical Devices Regulations 2002 (legislation.gov.uk)
- UK MDR (2002). The Medical Devices Regulations 2002. Retrieved on 29.04.2021 from The Medical Devices Regulations 2002 (legislation.gov.uk)